User login
Bariatric surgery may be appropriate for class 1 obesity
LAS VEGAS – Once reserved for the most obese patients, bariatric surgery is on the road to becoming an option for millions of Americans who are just a step beyond overweight, even those with a body mass index as low as 30 kg/m2.
In regard to patients with lower levels of obesity, “we should be intervening in this chronic disease earlier rather than later,” said Stacy A. Brethauer, MD, professor of surgery at the Ohio State University, Columbus, in a presentation about new standards for bariatric surgery at the 2019 Annual Minimally Invasive Surgery Symposium by Global Academy for Medical Education.
Bariatric treatment “should be offered after nonsurgical [weight-loss] therapy has failed,” he said. “That’s not where you stop. You continue to escalate as you would for heart disease or cancer.”
As Dr. Brethauer noted, research suggests that all categories of obesity – including so-called class 1 obesity (defined as a BMI from 30.0 to 34.9 kg/m2) – boost the risk of multiple diseases, including hypertension, coronary artery disease, congestive heart failure, stroke, asthma, pulmonary embolism, gallbladder disease, several types of cancer, osteoarthritis, knee pain and chronic back pain.
“There is no question that class 1 obesity is clearly putting people at risk,” he said. “Ultimately, you can conclude from all this evidence that class 1 is a chronic disease, and it deserves to be treated effectively.”
There are, of course, various nonsurgical treatments for obesity, including diet and exercise and pharmacotherapy. However, systematic reviews have found that people find it extremely difficult to keep the weight off after 1 year regardless of the strategy they adopt.
Beyond a year, Dr. Brethauer said, “you get poor maintenance of weight control, and you get poor control of metabolic burden. You don’t have a durable efficacy.”
In the past, bariatric surgery wasn’t considered an option for patients with class 1 obesity. It’s traditionally been reserved for patients with BMIs at or above 35 kg/m2. But this standard has evolved in recent years.
In 2018, Dr. Brethauer coauthored an updated position statement by the American Society for Metabolic and Bariatric Surgery that encouraged bariatric surgery in certain mildly obese patients.
“For most people with class I obesity,” the statement on bariatric surgery states, “it is clear that the nonsurgical group of therapies will not provide a durable solution to their disease of obesity.”
The statement went on to say that “surgical intervention should be considered after failure of nonsurgical treatments” in the class 1 population.
Bariatric surgery in the class 1 population does more than reduce obesity, Dr. Brethauer said. “Over the last 5 years or so, a large body of literature has emerged,” he said, and both systematic reviews and randomized trails have shown significant postsurgery improvements in comorbidities such as diabetes.
“It’s important to emphasize that these patients don’t become underweight,” he said. “The body finds a healthy set point. They don’t become underweight or malnourished because you’re operating on a lower-weight group.”
Are weight-loss operations safe in class 1 patients? The American Society for Metabolic and Bariatric Surgery statement says that research has found “bariatric surgery is associated with modest morbidity and very low mortality in patients with class I obesity.”
In fact, Dr. Brethauer said, the mortality rate in this population is “less than gallbladder surgery, less than hip surgery, less than hysterectomy, less than knee surgery – operations people are being referred for and undergoing all the time.”
He added: “The case can be made very clearly based on this data that these operations are safe in this patient population. Not only are they safe, they have durable and significant impact on comorbidities.”
Global Academy for Medical Education and this news organization are owned by the same parent company. Dr. Brethauer discloses relationships with Medtronic (speaker) and GI Windows (consultant).
LAS VEGAS – Once reserved for the most obese patients, bariatric surgery is on the road to becoming an option for millions of Americans who are just a step beyond overweight, even those with a body mass index as low as 30 kg/m2.
In regard to patients with lower levels of obesity, “we should be intervening in this chronic disease earlier rather than later,” said Stacy A. Brethauer, MD, professor of surgery at the Ohio State University, Columbus, in a presentation about new standards for bariatric surgery at the 2019 Annual Minimally Invasive Surgery Symposium by Global Academy for Medical Education.
Bariatric treatment “should be offered after nonsurgical [weight-loss] therapy has failed,” he said. “That’s not where you stop. You continue to escalate as you would for heart disease or cancer.”
As Dr. Brethauer noted, research suggests that all categories of obesity – including so-called class 1 obesity (defined as a BMI from 30.0 to 34.9 kg/m2) – boost the risk of multiple diseases, including hypertension, coronary artery disease, congestive heart failure, stroke, asthma, pulmonary embolism, gallbladder disease, several types of cancer, osteoarthritis, knee pain and chronic back pain.
“There is no question that class 1 obesity is clearly putting people at risk,” he said. “Ultimately, you can conclude from all this evidence that class 1 is a chronic disease, and it deserves to be treated effectively.”
There are, of course, various nonsurgical treatments for obesity, including diet and exercise and pharmacotherapy. However, systematic reviews have found that people find it extremely difficult to keep the weight off after 1 year regardless of the strategy they adopt.
Beyond a year, Dr. Brethauer said, “you get poor maintenance of weight control, and you get poor control of metabolic burden. You don’t have a durable efficacy.”
In the past, bariatric surgery wasn’t considered an option for patients with class 1 obesity. It’s traditionally been reserved for patients with BMIs at or above 35 kg/m2. But this standard has evolved in recent years.
In 2018, Dr. Brethauer coauthored an updated position statement by the American Society for Metabolic and Bariatric Surgery that encouraged bariatric surgery in certain mildly obese patients.
“For most people with class I obesity,” the statement on bariatric surgery states, “it is clear that the nonsurgical group of therapies will not provide a durable solution to their disease of obesity.”
The statement went on to say that “surgical intervention should be considered after failure of nonsurgical treatments” in the class 1 population.
Bariatric surgery in the class 1 population does more than reduce obesity, Dr. Brethauer said. “Over the last 5 years or so, a large body of literature has emerged,” he said, and both systematic reviews and randomized trails have shown significant postsurgery improvements in comorbidities such as diabetes.
“It’s important to emphasize that these patients don’t become underweight,” he said. “The body finds a healthy set point. They don’t become underweight or malnourished because you’re operating on a lower-weight group.”
Are weight-loss operations safe in class 1 patients? The American Society for Metabolic and Bariatric Surgery statement says that research has found “bariatric surgery is associated with modest morbidity and very low mortality in patients with class I obesity.”
In fact, Dr. Brethauer said, the mortality rate in this population is “less than gallbladder surgery, less than hip surgery, less than hysterectomy, less than knee surgery – operations people are being referred for and undergoing all the time.”
He added: “The case can be made very clearly based on this data that these operations are safe in this patient population. Not only are they safe, they have durable and significant impact on comorbidities.”
Global Academy for Medical Education and this news organization are owned by the same parent company. Dr. Brethauer discloses relationships with Medtronic (speaker) and GI Windows (consultant).
LAS VEGAS – Once reserved for the most obese patients, bariatric surgery is on the road to becoming an option for millions of Americans who are just a step beyond overweight, even those with a body mass index as low as 30 kg/m2.
In regard to patients with lower levels of obesity, “we should be intervening in this chronic disease earlier rather than later,” said Stacy A. Brethauer, MD, professor of surgery at the Ohio State University, Columbus, in a presentation about new standards for bariatric surgery at the 2019 Annual Minimally Invasive Surgery Symposium by Global Academy for Medical Education.
Bariatric treatment “should be offered after nonsurgical [weight-loss] therapy has failed,” he said. “That’s not where you stop. You continue to escalate as you would for heart disease or cancer.”
As Dr. Brethauer noted, research suggests that all categories of obesity – including so-called class 1 obesity (defined as a BMI from 30.0 to 34.9 kg/m2) – boost the risk of multiple diseases, including hypertension, coronary artery disease, congestive heart failure, stroke, asthma, pulmonary embolism, gallbladder disease, several types of cancer, osteoarthritis, knee pain and chronic back pain.
“There is no question that class 1 obesity is clearly putting people at risk,” he said. “Ultimately, you can conclude from all this evidence that class 1 is a chronic disease, and it deserves to be treated effectively.”
There are, of course, various nonsurgical treatments for obesity, including diet and exercise and pharmacotherapy. However, systematic reviews have found that people find it extremely difficult to keep the weight off after 1 year regardless of the strategy they adopt.
Beyond a year, Dr. Brethauer said, “you get poor maintenance of weight control, and you get poor control of metabolic burden. You don’t have a durable efficacy.”
In the past, bariatric surgery wasn’t considered an option for patients with class 1 obesity. It’s traditionally been reserved for patients with BMIs at or above 35 kg/m2. But this standard has evolved in recent years.
In 2018, Dr. Brethauer coauthored an updated position statement by the American Society for Metabolic and Bariatric Surgery that encouraged bariatric surgery in certain mildly obese patients.
“For most people with class I obesity,” the statement on bariatric surgery states, “it is clear that the nonsurgical group of therapies will not provide a durable solution to their disease of obesity.”
The statement went on to say that “surgical intervention should be considered after failure of nonsurgical treatments” in the class 1 population.
Bariatric surgery in the class 1 population does more than reduce obesity, Dr. Brethauer said. “Over the last 5 years or so, a large body of literature has emerged,” he said, and both systematic reviews and randomized trails have shown significant postsurgery improvements in comorbidities such as diabetes.
“It’s important to emphasize that these patients don’t become underweight,” he said. “The body finds a healthy set point. They don’t become underweight or malnourished because you’re operating on a lower-weight group.”
Are weight-loss operations safe in class 1 patients? The American Society for Metabolic and Bariatric Surgery statement says that research has found “bariatric surgery is associated with modest morbidity and very low mortality in patients with class I obesity.”
In fact, Dr. Brethauer said, the mortality rate in this population is “less than gallbladder surgery, less than hip surgery, less than hysterectomy, less than knee surgery – operations people are being referred for and undergoing all the time.”
He added: “The case can be made very clearly based on this data that these operations are safe in this patient population. Not only are they safe, they have durable and significant impact on comorbidities.”
Global Academy for Medical Education and this news organization are owned by the same parent company. Dr. Brethauer discloses relationships with Medtronic (speaker) and GI Windows (consultant).
REPORTING FROM MISS
Bariatric surgery leads to less improvement in black patients
“Per this analysis, there are significant racial disparities in perioperative outcomes, weight loss, and quality of life after bariatric surgery,” wrote lead author Michael H. Wood, MD, of Wayne State University, Detroit, and his coauthors, adding that, “while biological differences may explain some of the disparity in outcomes, environmental, social, and behavioral factors likely play a role.” The study was published online in JAMA Surgery.
This study reviewed data from 14,210 participants in the Michigan Bariatric Surgery Collaborative (MBSC), a state-wide consortium and clinical registry of bariatric surgery patients. Matching cohorts were established for black (n = 7,105) and white (n = 7,105) patients who underwent a primary bariatric operation (Roux-en-Y gastric bypass, sleeve gastrectomy, or adjustable gastric banding) between June 2006 and January 2017. The only significant differences between cohorts – clarified as “never more than 1 or 2 percentage points” – were in regard to income brackets and procedure type.
At 30-day follow-up, the rate of overall complications was higher in black patients (628, 8.8%) than in white patients (481, 6.8%; adjusted odds ratio, 1.33; 95% confidence interval, 1.17-1.51; P = .02), as was the length of stay (mean, 2.2 days vs. 1.9 days; aOR, 0.30; 95% CI, 0.20-0.40; P less than .001). Black patients also had a higher rate of both ED visits (541 [11.6%] vs. 826 [7.6%]; aOR, 1.60; 95% CI, 1.43-1.79; P less than .001) and readmissions (414 [5.8%] vs. 245 [3.5%]; aOR, 1.73; 95% CI, 1.47-2.03; P less than .001).
In addition, at 1-year follow-up, black patients had a lower mean weight loss (32.0 kg vs. 38.3 kg; P less than .001) and percentage of total weight loss (26% vs. 29%; P less than .001) compared with white patients. And though black patients were more likely than white patients to report a high quality of life before surgery (2,672 [49.5%] vs. 2,354 [41.4%]; P less than .001), they were less likely to do so 1 year afterward (1,379 [87.2%] vs. 2,133 [90.4%]; P = .002).
The coauthors acknowledged the limitations of their study, including potential unmeasured factors between cohorts such as disease duration or severity. They also noted that a wider time horizon than 30 days post surgery could have altered the results, although “serious adverse events and resource use tend to be highest within the first month after surgery, and we anticipate that this effect would have been negligible.”
The study was funded by Blue Cross Blue Shield Michigan/Blue Care Network. Dr. Wood reported no conflicts of interest. Three of his coauthors reported receiving salary support from Blue Cross Blue Shield Michigan/Blue Care Network for their work with the MBSC, and one other coauthor reported receiving an honorarium for being the MBSC’s executive committee chair.
SOURCE: Wood MH et al. JAMA Surg. 2019 Mar 6. doi: 10.1001/jamasurg.2019.0029.
The well-documented disparities between black and white patients after bariatric surgery are brought back to the forefront via to this study from Wood et al., according to Brian Hodgens, MD, and Kenric M. Murayama, MD, of the University of Hawaii, Honolulu.
Some of the findings hint at the cultural differences that permeate the time before and after a surgery like this: In particular, they highlighted how black patients were more likely to report good or very good quality of life before surgery but less likely after. This could be related to a “difference in perceptions of obesity by black patients,” where they are more hesitant to pursue the surgery than their white counterparts, Dr. Hodgens and Dr. Murayama wrote.
More work is needed, they added, but “this study and others like it can better equip practicing bariatric surgeons to educate themselves and patients on expectations before and after bariatric surgery.”
These comments are adapted from an accompanying editorial ( JAMA Surg. 2019 Mar 6. doi: 1 0.1001/jamasurg.2019.0067 ). Dr. Murayama reported receiving personal fees from Medtronic outside the submitted work.
The well-documented disparities between black and white patients after bariatric surgery are brought back to the forefront via to this study from Wood et al., according to Brian Hodgens, MD, and Kenric M. Murayama, MD, of the University of Hawaii, Honolulu.
Some of the findings hint at the cultural differences that permeate the time before and after a surgery like this: In particular, they highlighted how black patients were more likely to report good or very good quality of life before surgery but less likely after. This could be related to a “difference in perceptions of obesity by black patients,” where they are more hesitant to pursue the surgery than their white counterparts, Dr. Hodgens and Dr. Murayama wrote.
More work is needed, they added, but “this study and others like it can better equip practicing bariatric surgeons to educate themselves and patients on expectations before and after bariatric surgery.”
These comments are adapted from an accompanying editorial ( JAMA Surg. 2019 Mar 6. doi: 1 0.1001/jamasurg.2019.0067 ). Dr. Murayama reported receiving personal fees from Medtronic outside the submitted work.
The well-documented disparities between black and white patients after bariatric surgery are brought back to the forefront via to this study from Wood et al., according to Brian Hodgens, MD, and Kenric M. Murayama, MD, of the University of Hawaii, Honolulu.
Some of the findings hint at the cultural differences that permeate the time before and after a surgery like this: In particular, they highlighted how black patients were more likely to report good or very good quality of life before surgery but less likely after. This could be related to a “difference in perceptions of obesity by black patients,” where they are more hesitant to pursue the surgery than their white counterparts, Dr. Hodgens and Dr. Murayama wrote.
More work is needed, they added, but “this study and others like it can better equip practicing bariatric surgeons to educate themselves and patients on expectations before and after bariatric surgery.”
These comments are adapted from an accompanying editorial ( JAMA Surg. 2019 Mar 6. doi: 1 0.1001/jamasurg.2019.0067 ). Dr. Murayama reported receiving personal fees from Medtronic outside the submitted work.
“Per this analysis, there are significant racial disparities in perioperative outcomes, weight loss, and quality of life after bariatric surgery,” wrote lead author Michael H. Wood, MD, of Wayne State University, Detroit, and his coauthors, adding that, “while biological differences may explain some of the disparity in outcomes, environmental, social, and behavioral factors likely play a role.” The study was published online in JAMA Surgery.
This study reviewed data from 14,210 participants in the Michigan Bariatric Surgery Collaborative (MBSC), a state-wide consortium and clinical registry of bariatric surgery patients. Matching cohorts were established for black (n = 7,105) and white (n = 7,105) patients who underwent a primary bariatric operation (Roux-en-Y gastric bypass, sleeve gastrectomy, or adjustable gastric banding) between June 2006 and January 2017. The only significant differences between cohorts – clarified as “never more than 1 or 2 percentage points” – were in regard to income brackets and procedure type.
At 30-day follow-up, the rate of overall complications was higher in black patients (628, 8.8%) than in white patients (481, 6.8%; adjusted odds ratio, 1.33; 95% confidence interval, 1.17-1.51; P = .02), as was the length of stay (mean, 2.2 days vs. 1.9 days; aOR, 0.30; 95% CI, 0.20-0.40; P less than .001). Black patients also had a higher rate of both ED visits (541 [11.6%] vs. 826 [7.6%]; aOR, 1.60; 95% CI, 1.43-1.79; P less than .001) and readmissions (414 [5.8%] vs. 245 [3.5%]; aOR, 1.73; 95% CI, 1.47-2.03; P less than .001).
In addition, at 1-year follow-up, black patients had a lower mean weight loss (32.0 kg vs. 38.3 kg; P less than .001) and percentage of total weight loss (26% vs. 29%; P less than .001) compared with white patients. And though black patients were more likely than white patients to report a high quality of life before surgery (2,672 [49.5%] vs. 2,354 [41.4%]; P less than .001), they were less likely to do so 1 year afterward (1,379 [87.2%] vs. 2,133 [90.4%]; P = .002).
The coauthors acknowledged the limitations of their study, including potential unmeasured factors between cohorts such as disease duration or severity. They also noted that a wider time horizon than 30 days post surgery could have altered the results, although “serious adverse events and resource use tend to be highest within the first month after surgery, and we anticipate that this effect would have been negligible.”
The study was funded by Blue Cross Blue Shield Michigan/Blue Care Network. Dr. Wood reported no conflicts of interest. Three of his coauthors reported receiving salary support from Blue Cross Blue Shield Michigan/Blue Care Network for their work with the MBSC, and one other coauthor reported receiving an honorarium for being the MBSC’s executive committee chair.
SOURCE: Wood MH et al. JAMA Surg. 2019 Mar 6. doi: 10.1001/jamasurg.2019.0029.
“Per this analysis, there are significant racial disparities in perioperative outcomes, weight loss, and quality of life after bariatric surgery,” wrote lead author Michael H. Wood, MD, of Wayne State University, Detroit, and his coauthors, adding that, “while biological differences may explain some of the disparity in outcomes, environmental, social, and behavioral factors likely play a role.” The study was published online in JAMA Surgery.
This study reviewed data from 14,210 participants in the Michigan Bariatric Surgery Collaborative (MBSC), a state-wide consortium and clinical registry of bariatric surgery patients. Matching cohorts were established for black (n = 7,105) and white (n = 7,105) patients who underwent a primary bariatric operation (Roux-en-Y gastric bypass, sleeve gastrectomy, or adjustable gastric banding) between June 2006 and January 2017. The only significant differences between cohorts – clarified as “never more than 1 or 2 percentage points” – were in regard to income brackets and procedure type.
At 30-day follow-up, the rate of overall complications was higher in black patients (628, 8.8%) than in white patients (481, 6.8%; adjusted odds ratio, 1.33; 95% confidence interval, 1.17-1.51; P = .02), as was the length of stay (mean, 2.2 days vs. 1.9 days; aOR, 0.30; 95% CI, 0.20-0.40; P less than .001). Black patients also had a higher rate of both ED visits (541 [11.6%] vs. 826 [7.6%]; aOR, 1.60; 95% CI, 1.43-1.79; P less than .001) and readmissions (414 [5.8%] vs. 245 [3.5%]; aOR, 1.73; 95% CI, 1.47-2.03; P less than .001).
In addition, at 1-year follow-up, black patients had a lower mean weight loss (32.0 kg vs. 38.3 kg; P less than .001) and percentage of total weight loss (26% vs. 29%; P less than .001) compared with white patients. And though black patients were more likely than white patients to report a high quality of life before surgery (2,672 [49.5%] vs. 2,354 [41.4%]; P less than .001), they were less likely to do so 1 year afterward (1,379 [87.2%] vs. 2,133 [90.4%]; P = .002).
The coauthors acknowledged the limitations of their study, including potential unmeasured factors between cohorts such as disease duration or severity. They also noted that a wider time horizon than 30 days post surgery could have altered the results, although “serious adverse events and resource use tend to be highest within the first month after surgery, and we anticipate that this effect would have been negligible.”
The study was funded by Blue Cross Blue Shield Michigan/Blue Care Network. Dr. Wood reported no conflicts of interest. Three of his coauthors reported receiving salary support from Blue Cross Blue Shield Michigan/Blue Care Network for their work with the MBSC, and one other coauthor reported receiving an honorarium for being the MBSC’s executive committee chair.
SOURCE: Wood MH et al. JAMA Surg. 2019 Mar 6. doi: 10.1001/jamasurg.2019.0029.
FROM JAMA SURGERY
Roux-en-Y achieves diabetes remission in majority of patients
Around three-quarters of people with type 2 diabetes mellitus (T2DM) who undergo Roux-en-Y gastric bypass experience remission of their disease within a year of the surgery, according to published findings from a population-based observational study. However, one in four of those people will have relapsed by 5 years, the authors noted.
Researchers looked at the effect of Roux-en-Y gastric bypass (RYGB) in 1,111 individuals with T2DM, compared with 1,074 controls who also had T2DM but did not undergo gastric bypass.
By 6 months after surgery, 65% of those who had undergone RYGB met the criteria for remission – defined as no use of glucose-lowering drugs and an HbA1c below 48 mmol/mol (less than 6.5%) or metformin monotherapy with HbA1c below 42 mmol/mol (less than 6.0%).
By 1 year, 74% of those who had surgery had achieved remission, and 73% of those remained in remission 5 years after surgery. However, at 2 years, 6% of those who had achieved remission in the first year had already relapsed; by 3 years, 12% had relapsed; and by 4 years, 18% had relapsed. By 5 years after surgery, a total of 27% of those who originally achieved remission in the first year had relapsed.
The overall prevalence of remission remained at 70% for every 6-month period during the duration of the study, which suggests that, although some achieved remission early and then relapsed, others achieved remission later.
Individuals who were aged 50-60 years were 12% less likely to achieve remission, compared with those who were younger than 40 years, whereas those aged 60 years or more were 17% less likely to achieve remission.
A longer duration of diabetes was also associated with a lower likelihood of achieving remission after RYGB; individuals who had had diabetes for 8 years or more had a 27% lower likelihood of remission, compared with those who had had the disease for less than 2 years.
A higher HbA1c (greater than 53 mmol/mol) was associated with a 19% lower likelihood of remission, and individuals using insulin had a 43% lower likelihood of remission.
“Overall, our findings add evidence to the importance of regular check-ups following RYGB, despite initial diabetes remission, and also suggest that timing of RYGB is important (i.e., consider RYGB while there are still functional pancreatic beta cells),” wrote Lene R. Madsen, MD, from the department of endocrinology and internal medicine at Aarhus (Denmark) University Hospital and her colleagues.
The study also examined the effect of RYGB on microvascular and macrovascular diabetes complications. This revealed that the incidence of diabetic retinopathy was nearly halved among individuals who had undergone gastric bypass, the incidence of hospital-coded diabetic kidney disease was 46% lower, and the incidence of diabetic neuropathy was 16% lower.
In particular, individuals who achieved remission in the first year after surgery had a 57% lower incidence of microvascular events, compared with those who did not have surgery.
The authors noted that individuals who did not reach the threshold for diabetes remission after surgery still showed signs of better glycemic control, compared with individuals who had not undergone surgery.
“This aligns with the theory of ‘metabolic memory’ introduced by Coleman et al. [Diabetes Care. 2016;39(8):1400-07], suggesting that time spent in diabetes remission after RYGB is not spent in vain when it comes to reducing the risk of subsequent microvascular complications,” they wrote.
The surgery was also associated with a 46% reduction in the incidence of ischemic heart disease. In the first 30 days after surgery, 7.5% of patients were readmitted to hospital for any surgical complication, but the 90-day mortality rate after surgery was less than 0.5%.
The study was supported by the Health Research Fund of Central Denmark, the Novo Nordisk Foundation, and the A.P. Møller Foundation. The authors reported no conflicts of interest.
SOURCE: Madsen LR et al. Diabetologia. 2019, Feb 6. doi: 10.1007/s00125-019-4816-2.
Around three-quarters of people with type 2 diabetes mellitus (T2DM) who undergo Roux-en-Y gastric bypass experience remission of their disease within a year of the surgery, according to published findings from a population-based observational study. However, one in four of those people will have relapsed by 5 years, the authors noted.
Researchers looked at the effect of Roux-en-Y gastric bypass (RYGB) in 1,111 individuals with T2DM, compared with 1,074 controls who also had T2DM but did not undergo gastric bypass.
By 6 months after surgery, 65% of those who had undergone RYGB met the criteria for remission – defined as no use of glucose-lowering drugs and an HbA1c below 48 mmol/mol (less than 6.5%) or metformin monotherapy with HbA1c below 42 mmol/mol (less than 6.0%).
By 1 year, 74% of those who had surgery had achieved remission, and 73% of those remained in remission 5 years after surgery. However, at 2 years, 6% of those who had achieved remission in the first year had already relapsed; by 3 years, 12% had relapsed; and by 4 years, 18% had relapsed. By 5 years after surgery, a total of 27% of those who originally achieved remission in the first year had relapsed.
The overall prevalence of remission remained at 70% for every 6-month period during the duration of the study, which suggests that, although some achieved remission early and then relapsed, others achieved remission later.
Individuals who were aged 50-60 years were 12% less likely to achieve remission, compared with those who were younger than 40 years, whereas those aged 60 years or more were 17% less likely to achieve remission.
A longer duration of diabetes was also associated with a lower likelihood of achieving remission after RYGB; individuals who had had diabetes for 8 years or more had a 27% lower likelihood of remission, compared with those who had had the disease for less than 2 years.
A higher HbA1c (greater than 53 mmol/mol) was associated with a 19% lower likelihood of remission, and individuals using insulin had a 43% lower likelihood of remission.
“Overall, our findings add evidence to the importance of regular check-ups following RYGB, despite initial diabetes remission, and also suggest that timing of RYGB is important (i.e., consider RYGB while there are still functional pancreatic beta cells),” wrote Lene R. Madsen, MD, from the department of endocrinology and internal medicine at Aarhus (Denmark) University Hospital and her colleagues.
The study also examined the effect of RYGB on microvascular and macrovascular diabetes complications. This revealed that the incidence of diabetic retinopathy was nearly halved among individuals who had undergone gastric bypass, the incidence of hospital-coded diabetic kidney disease was 46% lower, and the incidence of diabetic neuropathy was 16% lower.
In particular, individuals who achieved remission in the first year after surgery had a 57% lower incidence of microvascular events, compared with those who did not have surgery.
The authors noted that individuals who did not reach the threshold for diabetes remission after surgery still showed signs of better glycemic control, compared with individuals who had not undergone surgery.
“This aligns with the theory of ‘metabolic memory’ introduced by Coleman et al. [Diabetes Care. 2016;39(8):1400-07], suggesting that time spent in diabetes remission after RYGB is not spent in vain when it comes to reducing the risk of subsequent microvascular complications,” they wrote.
The surgery was also associated with a 46% reduction in the incidence of ischemic heart disease. In the first 30 days after surgery, 7.5% of patients were readmitted to hospital for any surgical complication, but the 90-day mortality rate after surgery was less than 0.5%.
The study was supported by the Health Research Fund of Central Denmark, the Novo Nordisk Foundation, and the A.P. Møller Foundation. The authors reported no conflicts of interest.
SOURCE: Madsen LR et al. Diabetologia. 2019, Feb 6. doi: 10.1007/s00125-019-4816-2.
Around three-quarters of people with type 2 diabetes mellitus (T2DM) who undergo Roux-en-Y gastric bypass experience remission of their disease within a year of the surgery, according to published findings from a population-based observational study. However, one in four of those people will have relapsed by 5 years, the authors noted.
Researchers looked at the effect of Roux-en-Y gastric bypass (RYGB) in 1,111 individuals with T2DM, compared with 1,074 controls who also had T2DM but did not undergo gastric bypass.
By 6 months after surgery, 65% of those who had undergone RYGB met the criteria for remission – defined as no use of glucose-lowering drugs and an HbA1c below 48 mmol/mol (less than 6.5%) or metformin monotherapy with HbA1c below 42 mmol/mol (less than 6.0%).
By 1 year, 74% of those who had surgery had achieved remission, and 73% of those remained in remission 5 years after surgery. However, at 2 years, 6% of those who had achieved remission in the first year had already relapsed; by 3 years, 12% had relapsed; and by 4 years, 18% had relapsed. By 5 years after surgery, a total of 27% of those who originally achieved remission in the first year had relapsed.
The overall prevalence of remission remained at 70% for every 6-month period during the duration of the study, which suggests that, although some achieved remission early and then relapsed, others achieved remission later.
Individuals who were aged 50-60 years were 12% less likely to achieve remission, compared with those who were younger than 40 years, whereas those aged 60 years or more were 17% less likely to achieve remission.
A longer duration of diabetes was also associated with a lower likelihood of achieving remission after RYGB; individuals who had had diabetes for 8 years or more had a 27% lower likelihood of remission, compared with those who had had the disease for less than 2 years.
A higher HbA1c (greater than 53 mmol/mol) was associated with a 19% lower likelihood of remission, and individuals using insulin had a 43% lower likelihood of remission.
“Overall, our findings add evidence to the importance of regular check-ups following RYGB, despite initial diabetes remission, and also suggest that timing of RYGB is important (i.e., consider RYGB while there are still functional pancreatic beta cells),” wrote Lene R. Madsen, MD, from the department of endocrinology and internal medicine at Aarhus (Denmark) University Hospital and her colleagues.
The study also examined the effect of RYGB on microvascular and macrovascular diabetes complications. This revealed that the incidence of diabetic retinopathy was nearly halved among individuals who had undergone gastric bypass, the incidence of hospital-coded diabetic kidney disease was 46% lower, and the incidence of diabetic neuropathy was 16% lower.
In particular, individuals who achieved remission in the first year after surgery had a 57% lower incidence of microvascular events, compared with those who did not have surgery.
The authors noted that individuals who did not reach the threshold for diabetes remission after surgery still showed signs of better glycemic control, compared with individuals who had not undergone surgery.
“This aligns with the theory of ‘metabolic memory’ introduced by Coleman et al. [Diabetes Care. 2016;39(8):1400-07], suggesting that time spent in diabetes remission after RYGB is not spent in vain when it comes to reducing the risk of subsequent microvascular complications,” they wrote.
The surgery was also associated with a 46% reduction in the incidence of ischemic heart disease. In the first 30 days after surgery, 7.5% of patients were readmitted to hospital for any surgical complication, but the 90-day mortality rate after surgery was less than 0.5%.
The study was supported by the Health Research Fund of Central Denmark, the Novo Nordisk Foundation, and the A.P. Møller Foundation. The authors reported no conflicts of interest.
SOURCE: Madsen LR et al. Diabetologia. 2019, Feb 6. doi: 10.1007/s00125-019-4816-2.
FROM DIABETOLOGIA
Key clinical point: Diabetes remission was achieved in three-quarters of Roux-en-Y surgical patients.
Major finding: The incidence of diabetes remission 1 year after Roux-en-Y gastric bypass was 74%.
Study details: A population-based cohort study in 1,111 individuals with type 2 diabetes mellitus who underwent Roux-en-Y gastric bypass, compared with 1,074 nonsurgical controls with diabetes.
Disclosures: The study was supported by the Health Research Fund of Central Denmark, the Novo Nordisk Foundation, and the A.P. Møller Foundation. The authors reported no conflicts of interest.
Source: Madsen LR et al. Diabetologia. 2019, Feb 6. doi: 10.1007/s00125-019-4816-2.
Robotic sleeve gastrectomy may heighten organ space infection risk
While most outcomes are similar between robotic surgery and laparoscopic surgery for sleeve gastrectomy, the robotic approach carried a greater risk of organ space infection, according to the findings from a large clinical trial of more than 100,000 patients.
The study’s authors analyzed 107,726 sleeve gastrectomy operations in the Metabolic and Bariatric Surgery Association and Quality Improvement Program data registry (MBSAQIP), 7,385 of which were robotic sleeve gastrectomy (RSG). Peter William Lundberg, MD, and his coauthors of St. Luke’s University Health Network, Bethlehem, Pa., evaluated the safety of RSG vs. laparoscopic sleeve gastrectomy (LSG). The study was the first and largest comparing the two approaches to sleeve gastrectomy, the researchers noted.
“According to the MBSAQIP database, the robotic approach demonstrates a significantly higher rate of organ space infection while trending toward a lower rate of bleeding and 30-day reoperation and intervention,” Dr. Lundberg and his coauthors said.
Overall mortality was 0.07% in both groups (P = .49). The overall rates of significant adverse events were similar in both groups – 1.3% for LSG and 1.1% for RSG (P = .14) – as were bleeding rates – 0.5% and 0.4% (P = .003), respectively. The investigators characterized the slightly lower rates for RSG as “insignificant.”
RSG, however, had three times the rate of organ space infection than did the laparoscopic approach, 0.3% vs. 0.1% (P = .79). “Considering the enthusiasm with which robotics has been adopted by some bariatric surgeons, this is a sobering finding,” Dr. Lundberg noted.
The study determined that the use of staple-line reinforcement (SLR) alone significantly reduced the rate of bleeding regardless of approach by 31% on average (P = .0005). “This risk reduction was enhanced when SLR was combined with oversewing of the staple line,” Dr. Lundberg and his colleagues noted – an average reduction of 42% (P = .0009).
RSG took longer on average, 89 minutes vs. 63 minutes (P less than .0001), and the average length of stay was almost identical, 1.7 for RSG vs. 1.6 days for LSG. Reoperation rates within 30 days were also similar: 0.7% for RSG vs. 0.8% for LSG (P = .003).
“As surgeons continue to adopt and develop new technology, ongoing monitoring and reporting of safety and outcomes data are advised to maintain the high standards for outcomes in bariatric surgery,” Dr. Lundberg and his coauthors said.
The study researchers had no financial conflicts.
SOURCE: Lundberg PW et al. Surg Obes Relat Dis. 2018 Oct 25. doi:10.1016/j.soard.2018.10.015.
While most outcomes are similar between robotic surgery and laparoscopic surgery for sleeve gastrectomy, the robotic approach carried a greater risk of organ space infection, according to the findings from a large clinical trial of more than 100,000 patients.
The study’s authors analyzed 107,726 sleeve gastrectomy operations in the Metabolic and Bariatric Surgery Association and Quality Improvement Program data registry (MBSAQIP), 7,385 of which were robotic sleeve gastrectomy (RSG). Peter William Lundberg, MD, and his coauthors of St. Luke’s University Health Network, Bethlehem, Pa., evaluated the safety of RSG vs. laparoscopic sleeve gastrectomy (LSG). The study was the first and largest comparing the two approaches to sleeve gastrectomy, the researchers noted.
“According to the MBSAQIP database, the robotic approach demonstrates a significantly higher rate of organ space infection while trending toward a lower rate of bleeding and 30-day reoperation and intervention,” Dr. Lundberg and his coauthors said.
Overall mortality was 0.07% in both groups (P = .49). The overall rates of significant adverse events were similar in both groups – 1.3% for LSG and 1.1% for RSG (P = .14) – as were bleeding rates – 0.5% and 0.4% (P = .003), respectively. The investigators characterized the slightly lower rates for RSG as “insignificant.”
RSG, however, had three times the rate of organ space infection than did the laparoscopic approach, 0.3% vs. 0.1% (P = .79). “Considering the enthusiasm with which robotics has been adopted by some bariatric surgeons, this is a sobering finding,” Dr. Lundberg noted.
The study determined that the use of staple-line reinforcement (SLR) alone significantly reduced the rate of bleeding regardless of approach by 31% on average (P = .0005). “This risk reduction was enhanced when SLR was combined with oversewing of the staple line,” Dr. Lundberg and his colleagues noted – an average reduction of 42% (P = .0009).
RSG took longer on average, 89 minutes vs. 63 minutes (P less than .0001), and the average length of stay was almost identical, 1.7 for RSG vs. 1.6 days for LSG. Reoperation rates within 30 days were also similar: 0.7% for RSG vs. 0.8% for LSG (P = .003).
“As surgeons continue to adopt and develop new technology, ongoing monitoring and reporting of safety and outcomes data are advised to maintain the high standards for outcomes in bariatric surgery,” Dr. Lundberg and his coauthors said.
The study researchers had no financial conflicts.
SOURCE: Lundberg PW et al. Surg Obes Relat Dis. 2018 Oct 25. doi:10.1016/j.soard.2018.10.015.
While most outcomes are similar between robotic surgery and laparoscopic surgery for sleeve gastrectomy, the robotic approach carried a greater risk of organ space infection, according to the findings from a large clinical trial of more than 100,000 patients.
The study’s authors analyzed 107,726 sleeve gastrectomy operations in the Metabolic and Bariatric Surgery Association and Quality Improvement Program data registry (MBSAQIP), 7,385 of which were robotic sleeve gastrectomy (RSG). Peter William Lundberg, MD, and his coauthors of St. Luke’s University Health Network, Bethlehem, Pa., evaluated the safety of RSG vs. laparoscopic sleeve gastrectomy (LSG). The study was the first and largest comparing the two approaches to sleeve gastrectomy, the researchers noted.
“According to the MBSAQIP database, the robotic approach demonstrates a significantly higher rate of organ space infection while trending toward a lower rate of bleeding and 30-day reoperation and intervention,” Dr. Lundberg and his coauthors said.
Overall mortality was 0.07% in both groups (P = .49). The overall rates of significant adverse events were similar in both groups – 1.3% for LSG and 1.1% for RSG (P = .14) – as were bleeding rates – 0.5% and 0.4% (P = .003), respectively. The investigators characterized the slightly lower rates for RSG as “insignificant.”
RSG, however, had three times the rate of organ space infection than did the laparoscopic approach, 0.3% vs. 0.1% (P = .79). “Considering the enthusiasm with which robotics has been adopted by some bariatric surgeons, this is a sobering finding,” Dr. Lundberg noted.
The study determined that the use of staple-line reinforcement (SLR) alone significantly reduced the rate of bleeding regardless of approach by 31% on average (P = .0005). “This risk reduction was enhanced when SLR was combined with oversewing of the staple line,” Dr. Lundberg and his colleagues noted – an average reduction of 42% (P = .0009).
RSG took longer on average, 89 minutes vs. 63 minutes (P less than .0001), and the average length of stay was almost identical, 1.7 for RSG vs. 1.6 days for LSG. Reoperation rates within 30 days were also similar: 0.7% for RSG vs. 0.8% for LSG (P = .003).
“As surgeons continue to adopt and develop new technology, ongoing monitoring and reporting of safety and outcomes data are advised to maintain the high standards for outcomes in bariatric surgery,” Dr. Lundberg and his coauthors said.
The study researchers had no financial conflicts.
SOURCE: Lundberg PW et al. Surg Obes Relat Dis. 2018 Oct 25. doi:10.1016/j.soard.2018.10.015.
FROM SURGERY FOR OBESITY AND RELATED DISEASES
Key clinical point: Robotic sleeve gastrectomy carries a higher risk of organ space infection than does the laparoscopic approach.
Major finding: Rate of OSI was 0.3% with RSG and 0.1% with laparoscopic surgery.
Study details: An analysis of 107,726 patients who had sleeve gastrectomy in 2016 in the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program registry.
Disclosures: Dr. Lundberg and his coauthors reported having no conflicts.
Source: Lundberg PW et al. Surg Obes Related Dis. 2018 Oct. 25. doi:10.1016/j.soard.2018.10.015.
True postbariatric hyperinsulinemic hypoglycemia is rare
based on a decade’s worth of experience from the Mayo Clinic, Rochester, Minn.
Of 2,386 patients who had bariatric surgery at Mayo, 60 (2.6%) had a postsurgical diagnosis code associated with hypoglycemia in their medical record. However, just five of them (0.25%) had documentation meeting the criteria for Whipple’s Triad, which consists of low blood glucose levels, symptoms associated with the low glucose levels, and symptom resolution when glucose levels are corrected, Tiffany Cortes, MD, reported in an oral presentation at Obesity Week, which is presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery .
“Postbariatric hypoglycemia is an infrequent occurrence among patients who present with suspicious symptoms,” said Dr. Cortes, an endocrinology fellow at the clinic.
Post–bariatric surgery hypoglycemia is characterized by neuroglycopenia with a documented plasma glucose of less than 54 mg/dL with symptom resolution after a rise in glucose levels; neuroglycopenia that occurs 1-3 hours after a meal; and symptom onset more than 6 months after bariatric surgery, said Dr. Cortes.
Previous work had found that the overall prevalence of post–bariatric surgery hyperinsulinemic hypoglycemia ranged from 17%-34%, with severe symptoms seen in fewer than 1% of surgery recipients.
Bariatric surgery, especially Roux-en-Y gastric bypass (RYGB), may result in wide postprandial blood glucose excursions, with a spike occurring about 30 minutes after eating. For symptomatic individuals, this postprandial glucose peak will prompt an insulin surge followed by a rapid and steep decline in serum glucose.
Looking at Mayo Clinic medical records from mid-2008 to the end of 2017, Dr. Cortes and her colleagues wanted to determine the prevalence of hyperinsulinemic hypoglycemia in the bariatric surgery population.
Additionally, the researchers wanted to see how patients who presented with symptoms suspicious for the syndrome were evaluated and to understand the efficacy of treatments.
Patients who had a diagnosis of type 1 diabetes mellitus and those who were on insulin or sulfonylureas were excluded from the retrospective chart review.
Of the 60 patients evaluated in the endocrinology clinic for symptoms suspicious for hyperinsulinemic hypoglycemia, 51 (85%) were female, and 14 had a diagnosis of diabetes before surgery. Mean patient age at surgery was 43 years.
These symptomatic patients had a mean presurgical body mass index (BMI) of 42.8 kg/m2 (range, 38.6-49.3 kg/m2). Their mean time to maximal weight loss was 1.3 years after surgery, with symptoms beginning at 1.4 years after surgery. Patients lost a mean 37.4% of their body mass to reach a mean nadir BMI of 26.2.
Overall, about two-thirds of the surgeries performed were RYGB. Of patients with hypoglycemic symptoms, 73.3% had an RYGB. Revision of gastric bypass was the next most common surgery, at 21.8% overall; these patients constituted 15% of the hypoglycemic symptom group.
Of the patients with symptoms, 80% noted symptoms only after eating, with half of patients describing symptoms coming on 1-3 hours after eating. A little over a third of the patients didn’t describe the exact timing of symptoms.
Just 20 patients had a complete hypoglycemia work up bundle documented in their medical record, said Dr. Cortes. This consisted of measures of serum glucose, insulin, and C-peptide levels. Of the 20 patients, 5 met Whipple’s Triad criteria, and 4 of these patients received a diagnosis of hyperinsulinemic hypoglycemia.
Two patients had a 72-hour fast, and neither of them met diagnostic criteria. Seventeen patients had a mixed meal tolerance test, with one individual meeting diagnostic criteria for and receiving a diagnosis of hypoinsulinemic hyperglycemia.
Of the five patients meeting diagnostic criteria (0.20% of surgical population), all had received RYGB, and two had previous weight loss procedures, said Dr. Cortes. For four of the patients, the surgical indication was weight loss; the other patient had an indication of gastroesophageal reflux disease (GERD).
“Dietary interventions are the most effective treatment” for post–bariatric surgery hyperinsulinemic hypoglycemia in the Mayo Clinic experience, said Dr. Cortes.
Turning to the investigators’ examination of treatment recommendations for the 60 patients who reported hypoglycemic symptoms, most (95%) received an initial recommendation to manage symptoms by diet changes.
Most patients (77%) had at least one follow-up visit, with over half of these patients (61%) reporting improvement in symptoms, and seven patients (16%) reporting resolution. Twelve patients (27%) either remained the same or had not had a recurrence of symptoms.
Medication was prescribed for 12 patients; of them, 8 received the alpha glucosidase inhibitor acarbose and 7 responded, according to the record review. No one reported worsening of symptoms on acarbose.
Other individual patients were prescribed octreotide alone, or octreotide, pasireotide, or diazoxide in combination with acarbose, with variable results.
Dr. Cortes reported no conflicts of interest and no external sources of funding.
SOURCE: Cortes T et al. Obesity Week 2018, Abstract T-OR-2015.
based on a decade’s worth of experience from the Mayo Clinic, Rochester, Minn.
Of 2,386 patients who had bariatric surgery at Mayo, 60 (2.6%) had a postsurgical diagnosis code associated with hypoglycemia in their medical record. However, just five of them (0.25%) had documentation meeting the criteria for Whipple’s Triad, which consists of low blood glucose levels, symptoms associated with the low glucose levels, and symptom resolution when glucose levels are corrected, Tiffany Cortes, MD, reported in an oral presentation at Obesity Week, which is presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery .
“Postbariatric hypoglycemia is an infrequent occurrence among patients who present with suspicious symptoms,” said Dr. Cortes, an endocrinology fellow at the clinic.
Post–bariatric surgery hypoglycemia is characterized by neuroglycopenia with a documented plasma glucose of less than 54 mg/dL with symptom resolution after a rise in glucose levels; neuroglycopenia that occurs 1-3 hours after a meal; and symptom onset more than 6 months after bariatric surgery, said Dr. Cortes.
Previous work had found that the overall prevalence of post–bariatric surgery hyperinsulinemic hypoglycemia ranged from 17%-34%, with severe symptoms seen in fewer than 1% of surgery recipients.
Bariatric surgery, especially Roux-en-Y gastric bypass (RYGB), may result in wide postprandial blood glucose excursions, with a spike occurring about 30 minutes after eating. For symptomatic individuals, this postprandial glucose peak will prompt an insulin surge followed by a rapid and steep decline in serum glucose.
Looking at Mayo Clinic medical records from mid-2008 to the end of 2017, Dr. Cortes and her colleagues wanted to determine the prevalence of hyperinsulinemic hypoglycemia in the bariatric surgery population.
Additionally, the researchers wanted to see how patients who presented with symptoms suspicious for the syndrome were evaluated and to understand the efficacy of treatments.
Patients who had a diagnosis of type 1 diabetes mellitus and those who were on insulin or sulfonylureas were excluded from the retrospective chart review.
Of the 60 patients evaluated in the endocrinology clinic for symptoms suspicious for hyperinsulinemic hypoglycemia, 51 (85%) were female, and 14 had a diagnosis of diabetes before surgery. Mean patient age at surgery was 43 years.
These symptomatic patients had a mean presurgical body mass index (BMI) of 42.8 kg/m2 (range, 38.6-49.3 kg/m2). Their mean time to maximal weight loss was 1.3 years after surgery, with symptoms beginning at 1.4 years after surgery. Patients lost a mean 37.4% of their body mass to reach a mean nadir BMI of 26.2.
Overall, about two-thirds of the surgeries performed were RYGB. Of patients with hypoglycemic symptoms, 73.3% had an RYGB. Revision of gastric bypass was the next most common surgery, at 21.8% overall; these patients constituted 15% of the hypoglycemic symptom group.
Of the patients with symptoms, 80% noted symptoms only after eating, with half of patients describing symptoms coming on 1-3 hours after eating. A little over a third of the patients didn’t describe the exact timing of symptoms.
Just 20 patients had a complete hypoglycemia work up bundle documented in their medical record, said Dr. Cortes. This consisted of measures of serum glucose, insulin, and C-peptide levels. Of the 20 patients, 5 met Whipple’s Triad criteria, and 4 of these patients received a diagnosis of hyperinsulinemic hypoglycemia.
Two patients had a 72-hour fast, and neither of them met diagnostic criteria. Seventeen patients had a mixed meal tolerance test, with one individual meeting diagnostic criteria for and receiving a diagnosis of hypoinsulinemic hyperglycemia.
Of the five patients meeting diagnostic criteria (0.20% of surgical population), all had received RYGB, and two had previous weight loss procedures, said Dr. Cortes. For four of the patients, the surgical indication was weight loss; the other patient had an indication of gastroesophageal reflux disease (GERD).
“Dietary interventions are the most effective treatment” for post–bariatric surgery hyperinsulinemic hypoglycemia in the Mayo Clinic experience, said Dr. Cortes.
Turning to the investigators’ examination of treatment recommendations for the 60 patients who reported hypoglycemic symptoms, most (95%) received an initial recommendation to manage symptoms by diet changes.
Most patients (77%) had at least one follow-up visit, with over half of these patients (61%) reporting improvement in symptoms, and seven patients (16%) reporting resolution. Twelve patients (27%) either remained the same or had not had a recurrence of symptoms.
Medication was prescribed for 12 patients; of them, 8 received the alpha glucosidase inhibitor acarbose and 7 responded, according to the record review. No one reported worsening of symptoms on acarbose.
Other individual patients were prescribed octreotide alone, or octreotide, pasireotide, or diazoxide in combination with acarbose, with variable results.
Dr. Cortes reported no conflicts of interest and no external sources of funding.
SOURCE: Cortes T et al. Obesity Week 2018, Abstract T-OR-2015.
based on a decade’s worth of experience from the Mayo Clinic, Rochester, Minn.
Of 2,386 patients who had bariatric surgery at Mayo, 60 (2.6%) had a postsurgical diagnosis code associated with hypoglycemia in their medical record. However, just five of them (0.25%) had documentation meeting the criteria for Whipple’s Triad, which consists of low blood glucose levels, symptoms associated with the low glucose levels, and symptom resolution when glucose levels are corrected, Tiffany Cortes, MD, reported in an oral presentation at Obesity Week, which is presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery .
“Postbariatric hypoglycemia is an infrequent occurrence among patients who present with suspicious symptoms,” said Dr. Cortes, an endocrinology fellow at the clinic.
Post–bariatric surgery hypoglycemia is characterized by neuroglycopenia with a documented plasma glucose of less than 54 mg/dL with symptom resolution after a rise in glucose levels; neuroglycopenia that occurs 1-3 hours after a meal; and symptom onset more than 6 months after bariatric surgery, said Dr. Cortes.
Previous work had found that the overall prevalence of post–bariatric surgery hyperinsulinemic hypoglycemia ranged from 17%-34%, with severe symptoms seen in fewer than 1% of surgery recipients.
Bariatric surgery, especially Roux-en-Y gastric bypass (RYGB), may result in wide postprandial blood glucose excursions, with a spike occurring about 30 minutes after eating. For symptomatic individuals, this postprandial glucose peak will prompt an insulin surge followed by a rapid and steep decline in serum glucose.
Looking at Mayo Clinic medical records from mid-2008 to the end of 2017, Dr. Cortes and her colleagues wanted to determine the prevalence of hyperinsulinemic hypoglycemia in the bariatric surgery population.
Additionally, the researchers wanted to see how patients who presented with symptoms suspicious for the syndrome were evaluated and to understand the efficacy of treatments.
Patients who had a diagnosis of type 1 diabetes mellitus and those who were on insulin or sulfonylureas were excluded from the retrospective chart review.
Of the 60 patients evaluated in the endocrinology clinic for symptoms suspicious for hyperinsulinemic hypoglycemia, 51 (85%) were female, and 14 had a diagnosis of diabetes before surgery. Mean patient age at surgery was 43 years.
These symptomatic patients had a mean presurgical body mass index (BMI) of 42.8 kg/m2 (range, 38.6-49.3 kg/m2). Their mean time to maximal weight loss was 1.3 years after surgery, with symptoms beginning at 1.4 years after surgery. Patients lost a mean 37.4% of their body mass to reach a mean nadir BMI of 26.2.
Overall, about two-thirds of the surgeries performed were RYGB. Of patients with hypoglycemic symptoms, 73.3% had an RYGB. Revision of gastric bypass was the next most common surgery, at 21.8% overall; these patients constituted 15% of the hypoglycemic symptom group.
Of the patients with symptoms, 80% noted symptoms only after eating, with half of patients describing symptoms coming on 1-3 hours after eating. A little over a third of the patients didn’t describe the exact timing of symptoms.
Just 20 patients had a complete hypoglycemia work up bundle documented in their medical record, said Dr. Cortes. This consisted of measures of serum glucose, insulin, and C-peptide levels. Of the 20 patients, 5 met Whipple’s Triad criteria, and 4 of these patients received a diagnosis of hyperinsulinemic hypoglycemia.
Two patients had a 72-hour fast, and neither of them met diagnostic criteria. Seventeen patients had a mixed meal tolerance test, with one individual meeting diagnostic criteria for and receiving a diagnosis of hypoinsulinemic hyperglycemia.
Of the five patients meeting diagnostic criteria (0.20% of surgical population), all had received RYGB, and two had previous weight loss procedures, said Dr. Cortes. For four of the patients, the surgical indication was weight loss; the other patient had an indication of gastroesophageal reflux disease (GERD).
“Dietary interventions are the most effective treatment” for post–bariatric surgery hyperinsulinemic hypoglycemia in the Mayo Clinic experience, said Dr. Cortes.
Turning to the investigators’ examination of treatment recommendations for the 60 patients who reported hypoglycemic symptoms, most (95%) received an initial recommendation to manage symptoms by diet changes.
Most patients (77%) had at least one follow-up visit, with over half of these patients (61%) reporting improvement in symptoms, and seven patients (16%) reporting resolution. Twelve patients (27%) either remained the same or had not had a recurrence of symptoms.
Medication was prescribed for 12 patients; of them, 8 received the alpha glucosidase inhibitor acarbose and 7 responded, according to the record review. No one reported worsening of symptoms on acarbose.
Other individual patients were prescribed octreotide alone, or octreotide, pasireotide, or diazoxide in combination with acarbose, with variable results.
Dr. Cortes reported no conflicts of interest and no external sources of funding.
SOURCE: Cortes T et al. Obesity Week 2018, Abstract T-OR-2015.
REPORTING FROM OBESITY WEEK 2018
Key clinical point: Less than 1% of bariatric surgery patients had hyperinsulinemic hypoglycemia.
Major finding: When strict diagnostic criteria were used, 0.20% received the diagnosis.
Study details: Single-center retrospective chart review of 2,386 patients receiving bariatric surgery.
Disclosures: Dr. Cortes reported no outside sources of funding and no conflicts of interest.
Source: Cortes T et al. Obesity Week 2018, Abstract T-OR-2015.
Bariatric surgery ups risk of suicide, self-harm
NASHVILLE – , according to findings from a meta-analysis presented at the meeting.
Overall, the odds ratio was 1.69 for self-harm or suicide after bariatric surgery (95% confidence interval, 1.62-1.76; P less than .001), “indicating a nearly 70% increase in risk for self-harm or suicide following bariatric surgery,” wrote Dawn Roberts, PhD, of Bradley University, Peoria, Ill., and her coauthor, Nicole Pearl of Washington University, St. Louis, in the poster accompanying the presentation.
Further, as elapsed time from surgery grew, the suicide rate dropped (effect size covariance, r = –0.25). “Thus, the greatest risk for self-harm or suicide appears to emerge in the years immediately following surgery,” Dr. Roberts said at the meeting presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.
The investigators had a primary objective of characterizing the association between bariatric surgery and suicide or self-harm. The secondary purpose of the meta-analysis was to find moderators of the association that could explain some of the variability that had previously been seen in studies looking at mental health outcomes after bariatric surgery.
Some of the potential moderators, explained the investigators, included the surgery type. With Roux-en-Y gastric bypass (RYGB), more tissue is removed, potentially causing “more extensive disruption of neural pathways,” the investigators wrote. With greater loss of small-intestine surface area might come more disruption of the gut-brain axis, along with unknown effects on metabolism and pharmacokinetics of psychiatric medication. Additionally, alcohol use disorder might have a more profound effect after gastric bypass surgery.
It had previously been shown that more than two-thirds of suicides happen within the first 3 years after bariatric surgery. With the initial weight loss comes renegotiation of personal relationships, and the potential for more mobility and perhaps expanded career choices; stress accompanies even positive changes in these major life domains. Some patients will also experience weight regain within the first 3 years, after an initial nadir. This also can cause deterioration in quality of life, the investigators explained.
Dr. Roberts and her coinvestigator acknowledge that some of the potential moderators may have been missed in the initial data reporting. For example, the “presurgical sample may be at higher risk for suicide or self-injury but withhold psychiatric history during evaluation for fear of being rejected for surgery.”
From an initial 2,676 studies identified for consideration, investigators in the end extracted data from 28 studies from the United States, Canada, Sweden, and Brazil. The studies had considerable heterogeneity in methods; some included presurgery/postsurgery analyses of the same patients, some had a comparator nonsurgical group, and some used a single postsurgical assessment.
In studies where no nonbariatric comparison sample was available, the investigators assigned interpolated comparison. To arrive at this measure, they drew on the World Health Organization–reported base rate of suicides in the study country at the approximate year of assessment. Suicide was the only interpolated outcome.
Various measures of suicide and self-harm were captured, including completed and probable suicides, suicide attempts, and self-harm events. In some studies, information was drawn from a suicide-specific questionnaire, or from a suicide item on another type of questionnaire.
There was significant variability in the odds ratios for suicide or self-harm across studies, Dr. Roberts said.
The researchers plan to continue analyzing additional measures captured in the meta-analysis, such as gender, age, initial body mass index, surgery type, and the percent of excess weight lost at the time of assessment for suicide or self-harm risk. They reported no outside sources of funding, and no conflicts of interest.
SOURCE: Roberts, D et al. Obesity Week 2018, Poster A433.
NASHVILLE – , according to findings from a meta-analysis presented at the meeting.
Overall, the odds ratio was 1.69 for self-harm or suicide after bariatric surgery (95% confidence interval, 1.62-1.76; P less than .001), “indicating a nearly 70% increase in risk for self-harm or suicide following bariatric surgery,” wrote Dawn Roberts, PhD, of Bradley University, Peoria, Ill., and her coauthor, Nicole Pearl of Washington University, St. Louis, in the poster accompanying the presentation.
Further, as elapsed time from surgery grew, the suicide rate dropped (effect size covariance, r = –0.25). “Thus, the greatest risk for self-harm or suicide appears to emerge in the years immediately following surgery,” Dr. Roberts said at the meeting presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.
The investigators had a primary objective of characterizing the association between bariatric surgery and suicide or self-harm. The secondary purpose of the meta-analysis was to find moderators of the association that could explain some of the variability that had previously been seen in studies looking at mental health outcomes after bariatric surgery.
Some of the potential moderators, explained the investigators, included the surgery type. With Roux-en-Y gastric bypass (RYGB), more tissue is removed, potentially causing “more extensive disruption of neural pathways,” the investigators wrote. With greater loss of small-intestine surface area might come more disruption of the gut-brain axis, along with unknown effects on metabolism and pharmacokinetics of psychiatric medication. Additionally, alcohol use disorder might have a more profound effect after gastric bypass surgery.
It had previously been shown that more than two-thirds of suicides happen within the first 3 years after bariatric surgery. With the initial weight loss comes renegotiation of personal relationships, and the potential for more mobility and perhaps expanded career choices; stress accompanies even positive changes in these major life domains. Some patients will also experience weight regain within the first 3 years, after an initial nadir. This also can cause deterioration in quality of life, the investigators explained.
Dr. Roberts and her coinvestigator acknowledge that some of the potential moderators may have been missed in the initial data reporting. For example, the “presurgical sample may be at higher risk for suicide or self-injury but withhold psychiatric history during evaluation for fear of being rejected for surgery.”
From an initial 2,676 studies identified for consideration, investigators in the end extracted data from 28 studies from the United States, Canada, Sweden, and Brazil. The studies had considerable heterogeneity in methods; some included presurgery/postsurgery analyses of the same patients, some had a comparator nonsurgical group, and some used a single postsurgical assessment.
In studies where no nonbariatric comparison sample was available, the investigators assigned interpolated comparison. To arrive at this measure, they drew on the World Health Organization–reported base rate of suicides in the study country at the approximate year of assessment. Suicide was the only interpolated outcome.
Various measures of suicide and self-harm were captured, including completed and probable suicides, suicide attempts, and self-harm events. In some studies, information was drawn from a suicide-specific questionnaire, or from a suicide item on another type of questionnaire.
There was significant variability in the odds ratios for suicide or self-harm across studies, Dr. Roberts said.
The researchers plan to continue analyzing additional measures captured in the meta-analysis, such as gender, age, initial body mass index, surgery type, and the percent of excess weight lost at the time of assessment for suicide or self-harm risk. They reported no outside sources of funding, and no conflicts of interest.
SOURCE: Roberts, D et al. Obesity Week 2018, Poster A433.
NASHVILLE – , according to findings from a meta-analysis presented at the meeting.
Overall, the odds ratio was 1.69 for self-harm or suicide after bariatric surgery (95% confidence interval, 1.62-1.76; P less than .001), “indicating a nearly 70% increase in risk for self-harm or suicide following bariatric surgery,” wrote Dawn Roberts, PhD, of Bradley University, Peoria, Ill., and her coauthor, Nicole Pearl of Washington University, St. Louis, in the poster accompanying the presentation.
Further, as elapsed time from surgery grew, the suicide rate dropped (effect size covariance, r = –0.25). “Thus, the greatest risk for self-harm or suicide appears to emerge in the years immediately following surgery,” Dr. Roberts said at the meeting presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.
The investigators had a primary objective of characterizing the association between bariatric surgery and suicide or self-harm. The secondary purpose of the meta-analysis was to find moderators of the association that could explain some of the variability that had previously been seen in studies looking at mental health outcomes after bariatric surgery.
Some of the potential moderators, explained the investigators, included the surgery type. With Roux-en-Y gastric bypass (RYGB), more tissue is removed, potentially causing “more extensive disruption of neural pathways,” the investigators wrote. With greater loss of small-intestine surface area might come more disruption of the gut-brain axis, along with unknown effects on metabolism and pharmacokinetics of psychiatric medication. Additionally, alcohol use disorder might have a more profound effect after gastric bypass surgery.
It had previously been shown that more than two-thirds of suicides happen within the first 3 years after bariatric surgery. With the initial weight loss comes renegotiation of personal relationships, and the potential for more mobility and perhaps expanded career choices; stress accompanies even positive changes in these major life domains. Some patients will also experience weight regain within the first 3 years, after an initial nadir. This also can cause deterioration in quality of life, the investigators explained.
Dr. Roberts and her coinvestigator acknowledge that some of the potential moderators may have been missed in the initial data reporting. For example, the “presurgical sample may be at higher risk for suicide or self-injury but withhold psychiatric history during evaluation for fear of being rejected for surgery.”
From an initial 2,676 studies identified for consideration, investigators in the end extracted data from 28 studies from the United States, Canada, Sweden, and Brazil. The studies had considerable heterogeneity in methods; some included presurgery/postsurgery analyses of the same patients, some had a comparator nonsurgical group, and some used a single postsurgical assessment.
In studies where no nonbariatric comparison sample was available, the investigators assigned interpolated comparison. To arrive at this measure, they drew on the World Health Organization–reported base rate of suicides in the study country at the approximate year of assessment. Suicide was the only interpolated outcome.
Various measures of suicide and self-harm were captured, including completed and probable suicides, suicide attempts, and self-harm events. In some studies, information was drawn from a suicide-specific questionnaire, or from a suicide item on another type of questionnaire.
There was significant variability in the odds ratios for suicide or self-harm across studies, Dr. Roberts said.
The researchers plan to continue analyzing additional measures captured in the meta-analysis, such as gender, age, initial body mass index, surgery type, and the percent of excess weight lost at the time of assessment for suicide or self-harm risk. They reported no outside sources of funding, and no conflicts of interest.
SOURCE: Roberts, D et al. Obesity Week 2018, Poster A433.
REPORTING FROM OBESITY WEEK 2018
Key clinical point: Bariatric surgery patients have an elevated risk for suicide or self-harm.
Major finding: The odds ratio for suicide or self-harm was 1.69 after bariatric surgery.
Study details: Meta-analysis of 28 studies of bariatric surgery patients.
Disclosures: The authors reported no conflicts of interest and no outside sources of funding.
Source: Roberts D et al. Obesity Week 2018, Poster A433.
Gastric banding, metformin “equal” for slowing early T2DM progression
BERLIN – Gastric banding surgery and metformin produce similar improvements in insulin sensitivity and parameters indicative of preserved beta-cell function in patients with impaired glucose tolerance (IGT) or newly diagnosed type 2 diabetes mellitus (T2DM), according to the results of a study conducted by the Restoring Insulin Secretion (RISE) Consortium.
“Both interventions resulted in about 50% improvements in insulin sensitivity at 1 year, which was attenuated at 2 years,” reported study investigator Thomas Buchanan, MD, of the University of Southern California, Los Angeles, at the annual meeting of the European Association for the Study of Diabetes.
“The beta-cell responses fell in a pattern that maintained relatively, but not perfectly, stable compensation for insulin resistance,” he added.
Although glucose levels improved “only slightly,” he said, “acute compensation to glucose improved significantly with gastric banding and beta-cell compensation at maximal stimulation fell significantly with metformin.”
Results of the BetaFat (Beta Cell Restoration through Fat Mitigation) study, which are now published online in Diabetes Care, also showed that greater weight loss could be achieved with surgery versus metformin, with a 8.9 kg difference between the groups at 2 years (10.6 vs. 1.7 kg, respectively, P less than .01).
HDL cholesterol levels also rose with both interventions, and gastric banding resulted in a greater effect on very low–density lipoprotein cholesterol and triglycerides, as well as serum ALT, Dr. Buchanan said.
The BetaFat study is one of three “proof-of principle” studies currently being conducted by the RISE Consortium in patients with IGT, sometimes called prediabetes, and T2DM, explained Steven E. Kahn, MB, ChB, the chair for the RISE studies.
The other two multicenter, randomized trials being conducted by the RISE Consortium are looking at the effects of medications on preserving beta-cell function in pediatric/adolescent (10-19 years) and adult (21-65 years) populations with IGT or mild, recently diagnosed T2DM. The design, and some results, of these trials can be viewed on a dedicated section of the Diabetes Care website.
Beta-cell function is being assessed using “state-of-the-art” methods; the coprimary endpoint of the surgery versus metformin study was the steady state C-peptide level and acute C-peptide response at maximal glycemia measured using a hyperglycemic “clamp.”
The goal of the RISE studies is to test different approaches to preserve beta-cell function. It is designed to answer the question of which is more effective in this setting: sustained weight loss through gastric banding such as in the BetaFat study or medication.
Patients were eligible for inclusion in the study if they were aged 21-65 years, had a body mass index of 30-40 kg/m2, and had IGT or a diagnosis of T2DM within the past year for which they had received no diabetes medication at recruitment.
A total of 88 individuals were randomized with exactly half undergoing gastric banding. This consisted of a gastric band placed laparoscopically and adjusted every 2 months for the first year, and then every 3 months for the following year depending on symptoms and weight change.
Normoglycemia was observed in none of the study subjects at baseline but in 22% and 15% of those who had gastric banding or metformin, respectively, at 2 years (P = .66).
As for tolerability, five patients who underwent gastric banding experienced serious adverse events, of which two were caused by band slippage and three were caused other reasons. In the metformin arm, there were two serious adverse events, both unrelated to the medication.
“Gastric banding and metformin offered approximately equal approaches for improving insulin sensitivity in adults with mild to moderate obesity and impaired glucose tolerance or early, mild type 2 diabetes,” Dr. Buchanan concluded. “The predominant beta-cell response was a reduction in secretion to maintain a relatively constant compensation for insulin resistance, with only a small improvement in glucose. Whether these interventions will have different effects on beta-cell function over the long-term remains to be determined.”
Commenting on the study, Roy Taylor, MD, professor of medicine and metabolism at Newcastle University (England), noted that the changes in the lipid and liver parameters were important. Fasting plasma triglyceride levels fell from 1.3 mmol/L at baseline to 1.1 mmol/L at 2 years with surgery but stayed more or less the same with metformin (1.23 mmol/L and 1.28 mmol/L; P less than .009 comparing surgery and metformin groups at 2 years). Change in ALT levels were also significant comparing baseline values with results at 2 years, decreasing in the surgical group to a greater extent than in the metformin groups.
“There’s a really important message here, the predictors of a better response to the weight loss [i.e. changes in triglycerides and liver enzymes] are all there,” Dr. Taylor observed. “RISE has looked at 2 years of this effect, but the conversion to type 2 diabetes is probably going to happen over a longer time course.”
He added that “although the primary outcome measure of change in insulin secretion was not achieved, the writing is on the wall. These people, provided they maintain their weight loss, are likely to succeed. We see all the hallmarks of a successful outcome for the weight loss group – remove the primary driver for type 2 diabetes, and that group is on track.”
The RISE Consortium conducted the BetaFat study. The RISE Consortium is supported by grants from the National Institutes for Health. Further support came from the Department of Veterans Affairs, Kaiser Permanente Southern California, the American Diabetes Association, and Allergan. Additional donations of supplies were provided by Allergan, Apollo Endosurgery, Abbott, and Novo Nordisk. Dr. Buchanan reported receiving research funding from Allergan and Apollo Endosurgery. Dr. Taylor had no conflicts of interest.
SOURCES: Buchanan T et al. EASD 2018, Session S09; Xiang AH et al. Diabetes Care. 2018 Oct; dc181662.
BERLIN – Gastric banding surgery and metformin produce similar improvements in insulin sensitivity and parameters indicative of preserved beta-cell function in patients with impaired glucose tolerance (IGT) or newly diagnosed type 2 diabetes mellitus (T2DM), according to the results of a study conducted by the Restoring Insulin Secretion (RISE) Consortium.
“Both interventions resulted in about 50% improvements in insulin sensitivity at 1 year, which was attenuated at 2 years,” reported study investigator Thomas Buchanan, MD, of the University of Southern California, Los Angeles, at the annual meeting of the European Association for the Study of Diabetes.
“The beta-cell responses fell in a pattern that maintained relatively, but not perfectly, stable compensation for insulin resistance,” he added.
Although glucose levels improved “only slightly,” he said, “acute compensation to glucose improved significantly with gastric banding and beta-cell compensation at maximal stimulation fell significantly with metformin.”
Results of the BetaFat (Beta Cell Restoration through Fat Mitigation) study, which are now published online in Diabetes Care, also showed that greater weight loss could be achieved with surgery versus metformin, with a 8.9 kg difference between the groups at 2 years (10.6 vs. 1.7 kg, respectively, P less than .01).
HDL cholesterol levels also rose with both interventions, and gastric banding resulted in a greater effect on very low–density lipoprotein cholesterol and triglycerides, as well as serum ALT, Dr. Buchanan said.
The BetaFat study is one of three “proof-of principle” studies currently being conducted by the RISE Consortium in patients with IGT, sometimes called prediabetes, and T2DM, explained Steven E. Kahn, MB, ChB, the chair for the RISE studies.
The other two multicenter, randomized trials being conducted by the RISE Consortium are looking at the effects of medications on preserving beta-cell function in pediatric/adolescent (10-19 years) and adult (21-65 years) populations with IGT or mild, recently diagnosed T2DM. The design, and some results, of these trials can be viewed on a dedicated section of the Diabetes Care website.
Beta-cell function is being assessed using “state-of-the-art” methods; the coprimary endpoint of the surgery versus metformin study was the steady state C-peptide level and acute C-peptide response at maximal glycemia measured using a hyperglycemic “clamp.”
The goal of the RISE studies is to test different approaches to preserve beta-cell function. It is designed to answer the question of which is more effective in this setting: sustained weight loss through gastric banding such as in the BetaFat study or medication.
Patients were eligible for inclusion in the study if they were aged 21-65 years, had a body mass index of 30-40 kg/m2, and had IGT or a diagnosis of T2DM within the past year for which they had received no diabetes medication at recruitment.
A total of 88 individuals were randomized with exactly half undergoing gastric banding. This consisted of a gastric band placed laparoscopically and adjusted every 2 months for the first year, and then every 3 months for the following year depending on symptoms and weight change.
Normoglycemia was observed in none of the study subjects at baseline but in 22% and 15% of those who had gastric banding or metformin, respectively, at 2 years (P = .66).
As for tolerability, five patients who underwent gastric banding experienced serious adverse events, of which two were caused by band slippage and three were caused other reasons. In the metformin arm, there were two serious adverse events, both unrelated to the medication.
“Gastric banding and metformin offered approximately equal approaches for improving insulin sensitivity in adults with mild to moderate obesity and impaired glucose tolerance or early, mild type 2 diabetes,” Dr. Buchanan concluded. “The predominant beta-cell response was a reduction in secretion to maintain a relatively constant compensation for insulin resistance, with only a small improvement in glucose. Whether these interventions will have different effects on beta-cell function over the long-term remains to be determined.”
Commenting on the study, Roy Taylor, MD, professor of medicine and metabolism at Newcastle University (England), noted that the changes in the lipid and liver parameters were important. Fasting plasma triglyceride levels fell from 1.3 mmol/L at baseline to 1.1 mmol/L at 2 years with surgery but stayed more or less the same with metformin (1.23 mmol/L and 1.28 mmol/L; P less than .009 comparing surgery and metformin groups at 2 years). Change in ALT levels were also significant comparing baseline values with results at 2 years, decreasing in the surgical group to a greater extent than in the metformin groups.
“There’s a really important message here, the predictors of a better response to the weight loss [i.e. changes in triglycerides and liver enzymes] are all there,” Dr. Taylor observed. “RISE has looked at 2 years of this effect, but the conversion to type 2 diabetes is probably going to happen over a longer time course.”
He added that “although the primary outcome measure of change in insulin secretion was not achieved, the writing is on the wall. These people, provided they maintain their weight loss, are likely to succeed. We see all the hallmarks of a successful outcome for the weight loss group – remove the primary driver for type 2 diabetes, and that group is on track.”
The RISE Consortium conducted the BetaFat study. The RISE Consortium is supported by grants from the National Institutes for Health. Further support came from the Department of Veterans Affairs, Kaiser Permanente Southern California, the American Diabetes Association, and Allergan. Additional donations of supplies were provided by Allergan, Apollo Endosurgery, Abbott, and Novo Nordisk. Dr. Buchanan reported receiving research funding from Allergan and Apollo Endosurgery. Dr. Taylor had no conflicts of interest.
SOURCES: Buchanan T et al. EASD 2018, Session S09; Xiang AH et al. Diabetes Care. 2018 Oct; dc181662.
BERLIN – Gastric banding surgery and metformin produce similar improvements in insulin sensitivity and parameters indicative of preserved beta-cell function in patients with impaired glucose tolerance (IGT) or newly diagnosed type 2 diabetes mellitus (T2DM), according to the results of a study conducted by the Restoring Insulin Secretion (RISE) Consortium.
“Both interventions resulted in about 50% improvements in insulin sensitivity at 1 year, which was attenuated at 2 years,” reported study investigator Thomas Buchanan, MD, of the University of Southern California, Los Angeles, at the annual meeting of the European Association for the Study of Diabetes.
“The beta-cell responses fell in a pattern that maintained relatively, but not perfectly, stable compensation for insulin resistance,” he added.
Although glucose levels improved “only slightly,” he said, “acute compensation to glucose improved significantly with gastric banding and beta-cell compensation at maximal stimulation fell significantly with metformin.”
Results of the BetaFat (Beta Cell Restoration through Fat Mitigation) study, which are now published online in Diabetes Care, also showed that greater weight loss could be achieved with surgery versus metformin, with a 8.9 kg difference between the groups at 2 years (10.6 vs. 1.7 kg, respectively, P less than .01).
HDL cholesterol levels also rose with both interventions, and gastric banding resulted in a greater effect on very low–density lipoprotein cholesterol and triglycerides, as well as serum ALT, Dr. Buchanan said.
The BetaFat study is one of three “proof-of principle” studies currently being conducted by the RISE Consortium in patients with IGT, sometimes called prediabetes, and T2DM, explained Steven E. Kahn, MB, ChB, the chair for the RISE studies.
The other two multicenter, randomized trials being conducted by the RISE Consortium are looking at the effects of medications on preserving beta-cell function in pediatric/adolescent (10-19 years) and adult (21-65 years) populations with IGT or mild, recently diagnosed T2DM. The design, and some results, of these trials can be viewed on a dedicated section of the Diabetes Care website.
Beta-cell function is being assessed using “state-of-the-art” methods; the coprimary endpoint of the surgery versus metformin study was the steady state C-peptide level and acute C-peptide response at maximal glycemia measured using a hyperglycemic “clamp.”
The goal of the RISE studies is to test different approaches to preserve beta-cell function. It is designed to answer the question of which is more effective in this setting: sustained weight loss through gastric banding such as in the BetaFat study or medication.
Patients were eligible for inclusion in the study if they were aged 21-65 years, had a body mass index of 30-40 kg/m2, and had IGT or a diagnosis of T2DM within the past year for which they had received no diabetes medication at recruitment.
A total of 88 individuals were randomized with exactly half undergoing gastric banding. This consisted of a gastric band placed laparoscopically and adjusted every 2 months for the first year, and then every 3 months for the following year depending on symptoms and weight change.
Normoglycemia was observed in none of the study subjects at baseline but in 22% and 15% of those who had gastric banding or metformin, respectively, at 2 years (P = .66).
As for tolerability, five patients who underwent gastric banding experienced serious adverse events, of which two were caused by band slippage and three were caused other reasons. In the metformin arm, there were two serious adverse events, both unrelated to the medication.
“Gastric banding and metformin offered approximately equal approaches for improving insulin sensitivity in adults with mild to moderate obesity and impaired glucose tolerance or early, mild type 2 diabetes,” Dr. Buchanan concluded. “The predominant beta-cell response was a reduction in secretion to maintain a relatively constant compensation for insulin resistance, with only a small improvement in glucose. Whether these interventions will have different effects on beta-cell function over the long-term remains to be determined.”
Commenting on the study, Roy Taylor, MD, professor of medicine and metabolism at Newcastle University (England), noted that the changes in the lipid and liver parameters were important. Fasting plasma triglyceride levels fell from 1.3 mmol/L at baseline to 1.1 mmol/L at 2 years with surgery but stayed more or less the same with metformin (1.23 mmol/L and 1.28 mmol/L; P less than .009 comparing surgery and metformin groups at 2 years). Change in ALT levels were also significant comparing baseline values with results at 2 years, decreasing in the surgical group to a greater extent than in the metformin groups.
“There’s a really important message here, the predictors of a better response to the weight loss [i.e. changes in triglycerides and liver enzymes] are all there,” Dr. Taylor observed. “RISE has looked at 2 years of this effect, but the conversion to type 2 diabetes is probably going to happen over a longer time course.”
He added that “although the primary outcome measure of change in insulin secretion was not achieved, the writing is on the wall. These people, provided they maintain their weight loss, are likely to succeed. We see all the hallmarks of a successful outcome for the weight loss group – remove the primary driver for type 2 diabetes, and that group is on track.”
The RISE Consortium conducted the BetaFat study. The RISE Consortium is supported by grants from the National Institutes for Health. Further support came from the Department of Veterans Affairs, Kaiser Permanente Southern California, the American Diabetes Association, and Allergan. Additional donations of supplies were provided by Allergan, Apollo Endosurgery, Abbott, and Novo Nordisk. Dr. Buchanan reported receiving research funding from Allergan and Apollo Endosurgery. Dr. Taylor had no conflicts of interest.
SOURCES: Buchanan T et al. EASD 2018, Session S09; Xiang AH et al. Diabetes Care. 2018 Oct; dc181662.
REPORTING FROM EASD 2018
Key clinical point: Over 2 years, gastric banding surgery and metformin produced similar improvements in insulin sensitivity and parameters suggestive of preserved beta-cell function in patients with prediabetes or early type 2 diabetes.
Major finding: Around a 50% improvement in insulin sensitivity was seen in both study groups at 1 year with attenuation of the effect at 2 years.
Study details: The BetaFat study included 88 obese adults with impaired glucose tolerance or newly diagnosed early type 2 diabetes.
Disclosures: The study was part of the RISE studies, which are supported by grants from the National Institutes for Health. Further support comes from the Department of Veterans Affairs, Kaiser Permanente Southern California, the American Diabetes Association, and Allergan. Additional donations of supplies are provided by Allergan, Apollo Endosurgery, Abbott Laboratories, and Novo Nordisk. Dr. Buchanan reported research funding from Allergan and Apollo Endosurgery. Dr. Taylor had no conflicts of interest.
Sources: Buchanan T et al. EASD 2018, Session S09; Xiang AH et al. Diabetes Care. 2018 Oct; dc181662.
GBS in T2DM patients: Study highlights pros and cons, need for better patient selection
ORLANDO – , according to a nationwide, matched, observational cohort study in Sweden.
After 9 years of follow-up, all-cause mortality was 49% lower among 5,321 patients with T2DM compared with 5,321 matched control (183 vs. 351 deaths; hazard ratio, 0.51), as has been reported in prior studies, Vasileios Liakopoulos, MD, of the University of Gothenburg (Sweden) reported at the annual scientific sessions of the American Diabetes Association.
Cardiovascular disease (CVD) risk was 34% lower (108 vs. 150 patients; HR, 0.66), fatal CVD risk was 66% lower (21 vs. 64 patients; HR, 0.34), acute myocardial infarction risk was 45% lower (51 vs. 85 events; HR, 0.55) congestive heart failure risk was 51% lower (109 vs. 225 events; HR, 0.49), and cancer risk was 22% lower (153 vs. 188 cases; HR, 0.78) in cases vs. controls, respectively.
“[As for] the diagnoses that related to diabetes, hyperglycemia was lower by 66%, admission to the hospital due to amputation was 49% lower, and we also found something relatively new – that renal disease was lower by 42%,” Dr. Liakopoulos said.
Renal disease occurred in 105 cases vs. 187 controls (HR, 0.58), with the difference between the groups intensifying after the third year of follow-up, he noted.
However, numerous adverse events occurred more often in case patients, he said.
For example, hospitalizations for psychiatric disorders were increased by 33% (317 vs. 268; HR, 1.33), alcohol-related diagnoses were nearly threefold higher (180 vs. 65; HR, 2.90), malnutrition occurred nearly three times more often (128 vs. 46 patients; HR, 2.81), and anemia occurred nearly twice as often (84 vs. 46 cases; HR, 1.92) in cases vs. controls.
Of course, all the surgery-related adverse events occurred more often in the case patients, but interestingly, those events – which included things like gastrointestinal surgery other than gastric bypass, abdominal pain, gallstones/pancreatitis, gastrointestinal ulcers and reflux, and bowel obstruction – did not occur more often in case patients than in gastric bypass patients without diabetes in other studies, he noted.
The findings were based on merged data from the Scandinavian Obesity Surgery Registry, the Swedish National Diabetes Register, and other national databases, and persons with T2DM who had undergone gastric bypass surgery between 2007 and 2013 were matched by propensity score (based on sex, age, body mass index, and calendar time from the beginning of the study) with obese individuals who were not surgically treated for obesity. The risks of postoperative outcomes were assessed using a Cox regression model adjusted for sex, age, body mass index, and socioeconomic status, Dr. Liakopoulos said.
This study, though limited by its observational nature, minor differences in patient characteristics between the cases and controls, and potential residual confounding, confirms the benefits of gastric bypass surgery in obese patients with T2DM but also characterizes an array of both short- and long-term adverse events after bariatric surgery in these patients, he said.
“The beneficial effects of gastric bypass have been presented in terms of weight reduction, improvements in risk factors and cardiovascular disease, and mortality reduction in people with or without diabetes,” he said, noting, however, that only a few reports have addressed long-term incidence of complications after gastric bypass – and type 2 diabetes has only been addressed in small randomized studies or in low proportions in large prospective studies.
“[Based on the findings] we suggest better selection of patients for bariatric surgery, and we think improved long-term postoperative monitoring might further improve the results of such treatment,” he concluded.
Dr. Liakopoulos reported having no disclosures.
SOURCE: Liakopoulos V et al. ADA 2018, Abstract 131-OR.
ORLANDO – , according to a nationwide, matched, observational cohort study in Sweden.
After 9 years of follow-up, all-cause mortality was 49% lower among 5,321 patients with T2DM compared with 5,321 matched control (183 vs. 351 deaths; hazard ratio, 0.51), as has been reported in prior studies, Vasileios Liakopoulos, MD, of the University of Gothenburg (Sweden) reported at the annual scientific sessions of the American Diabetes Association.
Cardiovascular disease (CVD) risk was 34% lower (108 vs. 150 patients; HR, 0.66), fatal CVD risk was 66% lower (21 vs. 64 patients; HR, 0.34), acute myocardial infarction risk was 45% lower (51 vs. 85 events; HR, 0.55) congestive heart failure risk was 51% lower (109 vs. 225 events; HR, 0.49), and cancer risk was 22% lower (153 vs. 188 cases; HR, 0.78) in cases vs. controls, respectively.
“[As for] the diagnoses that related to diabetes, hyperglycemia was lower by 66%, admission to the hospital due to amputation was 49% lower, and we also found something relatively new – that renal disease was lower by 42%,” Dr. Liakopoulos said.
Renal disease occurred in 105 cases vs. 187 controls (HR, 0.58), with the difference between the groups intensifying after the third year of follow-up, he noted.
However, numerous adverse events occurred more often in case patients, he said.
For example, hospitalizations for psychiatric disorders were increased by 33% (317 vs. 268; HR, 1.33), alcohol-related diagnoses were nearly threefold higher (180 vs. 65; HR, 2.90), malnutrition occurred nearly three times more often (128 vs. 46 patients; HR, 2.81), and anemia occurred nearly twice as often (84 vs. 46 cases; HR, 1.92) in cases vs. controls.
Of course, all the surgery-related adverse events occurred more often in the case patients, but interestingly, those events – which included things like gastrointestinal surgery other than gastric bypass, abdominal pain, gallstones/pancreatitis, gastrointestinal ulcers and reflux, and bowel obstruction – did not occur more often in case patients than in gastric bypass patients without diabetes in other studies, he noted.
The findings were based on merged data from the Scandinavian Obesity Surgery Registry, the Swedish National Diabetes Register, and other national databases, and persons with T2DM who had undergone gastric bypass surgery between 2007 and 2013 were matched by propensity score (based on sex, age, body mass index, and calendar time from the beginning of the study) with obese individuals who were not surgically treated for obesity. The risks of postoperative outcomes were assessed using a Cox regression model adjusted for sex, age, body mass index, and socioeconomic status, Dr. Liakopoulos said.
This study, though limited by its observational nature, minor differences in patient characteristics between the cases and controls, and potential residual confounding, confirms the benefits of gastric bypass surgery in obese patients with T2DM but also characterizes an array of both short- and long-term adverse events after bariatric surgery in these patients, he said.
“The beneficial effects of gastric bypass have been presented in terms of weight reduction, improvements in risk factors and cardiovascular disease, and mortality reduction in people with or without diabetes,” he said, noting, however, that only a few reports have addressed long-term incidence of complications after gastric bypass – and type 2 diabetes has only been addressed in small randomized studies or in low proportions in large prospective studies.
“[Based on the findings] we suggest better selection of patients for bariatric surgery, and we think improved long-term postoperative monitoring might further improve the results of such treatment,” he concluded.
Dr. Liakopoulos reported having no disclosures.
SOURCE: Liakopoulos V et al. ADA 2018, Abstract 131-OR.
ORLANDO – , according to a nationwide, matched, observational cohort study in Sweden.
After 9 years of follow-up, all-cause mortality was 49% lower among 5,321 patients with T2DM compared with 5,321 matched control (183 vs. 351 deaths; hazard ratio, 0.51), as has been reported in prior studies, Vasileios Liakopoulos, MD, of the University of Gothenburg (Sweden) reported at the annual scientific sessions of the American Diabetes Association.
Cardiovascular disease (CVD) risk was 34% lower (108 vs. 150 patients; HR, 0.66), fatal CVD risk was 66% lower (21 vs. 64 patients; HR, 0.34), acute myocardial infarction risk was 45% lower (51 vs. 85 events; HR, 0.55) congestive heart failure risk was 51% lower (109 vs. 225 events; HR, 0.49), and cancer risk was 22% lower (153 vs. 188 cases; HR, 0.78) in cases vs. controls, respectively.
“[As for] the diagnoses that related to diabetes, hyperglycemia was lower by 66%, admission to the hospital due to amputation was 49% lower, and we also found something relatively new – that renal disease was lower by 42%,” Dr. Liakopoulos said.
Renal disease occurred in 105 cases vs. 187 controls (HR, 0.58), with the difference between the groups intensifying after the third year of follow-up, he noted.
However, numerous adverse events occurred more often in case patients, he said.
For example, hospitalizations for psychiatric disorders were increased by 33% (317 vs. 268; HR, 1.33), alcohol-related diagnoses were nearly threefold higher (180 vs. 65; HR, 2.90), malnutrition occurred nearly three times more often (128 vs. 46 patients; HR, 2.81), and anemia occurred nearly twice as often (84 vs. 46 cases; HR, 1.92) in cases vs. controls.
Of course, all the surgery-related adverse events occurred more often in the case patients, but interestingly, those events – which included things like gastrointestinal surgery other than gastric bypass, abdominal pain, gallstones/pancreatitis, gastrointestinal ulcers and reflux, and bowel obstruction – did not occur more often in case patients than in gastric bypass patients without diabetes in other studies, he noted.
The findings were based on merged data from the Scandinavian Obesity Surgery Registry, the Swedish National Diabetes Register, and other national databases, and persons with T2DM who had undergone gastric bypass surgery between 2007 and 2013 were matched by propensity score (based on sex, age, body mass index, and calendar time from the beginning of the study) with obese individuals who were not surgically treated for obesity. The risks of postoperative outcomes were assessed using a Cox regression model adjusted for sex, age, body mass index, and socioeconomic status, Dr. Liakopoulos said.
This study, though limited by its observational nature, minor differences in patient characteristics between the cases and controls, and potential residual confounding, confirms the benefits of gastric bypass surgery in obese patients with T2DM but also characterizes an array of both short- and long-term adverse events after bariatric surgery in these patients, he said.
“The beneficial effects of gastric bypass have been presented in terms of weight reduction, improvements in risk factors and cardiovascular disease, and mortality reduction in people with or without diabetes,” he said, noting, however, that only a few reports have addressed long-term incidence of complications after gastric bypass – and type 2 diabetes has only been addressed in small randomized studies or in low proportions in large prospective studies.
“[Based on the findings] we suggest better selection of patients for bariatric surgery, and we think improved long-term postoperative monitoring might further improve the results of such treatment,” he concluded.
Dr. Liakopoulos reported having no disclosures.
SOURCE: Liakopoulos V et al. ADA 2018, Abstract 131-OR.
REPORTING FROM ADA 2018
Key clinical point: Bariatric surgery lowers mortality, CVD, and renal and other risks in obese T2DM patients but also has high complication rates.
Major finding: All-cause mortality, CVD, and renal disease risks were 49%, 34%, and 42% lower, respectively, in cases vs. controls.
Study details: A matched observational cohort study of 5,321 cases and 5,321 controls.
Disclosures: Dr. Liakopoulos reported having no disclosures.
Source: Liakopoulos V et al. ADA 2018, Abstract 131-OR.
Enhanced recovery initiative improved bariatric length of stay
ORLANDO – Adopting a 28-point significantly reduced length of stay without significant effects on complications or readmissions, according to interim results of a large, nationwide surgical quality initiative. 
Thirty-six centers participated in this pilot initiative, making it one of the largest national projects focused on enhanced recovery to date, according to Stacy A. Brethauer, MD, FACS, cochair of the Quality and Data Committee of the Metabolic and Bariatric Surgery Accreditation Quality Improvement Program (MBSAQIP).
The initiative, known as Employing New Enhanced Recovery Goals for Bariatric Surgery (ENERGY), was developed in light of “huge gaps in literature and knowledge” about what best practices of enhanced recovery should look like for bariatric surgery, Dr. Brethauer said in a podium presentation at the American College of Surgeons Quality and Safety Conference.
“Bariatric surgery is very pathway driven, but the pathway can be very cumbersome and very antiquated if you don’t keep it up to date and evidence based,” said Dr. Brethauer, associate professor of surgery at the Cleveland Clinic.
Invitations to join in the ENERGY pilot were targeted to the 80 or so MBSAQIP-accredited centers in the top decile of programs for length of stay. “That’s the needle that we want to move,” Dr. Brethauer said.
ENERGY includes interventions in the preoperative, perioperative, and postoperative setting for each patient who undergoes a primary band, lap sleeve, or lap bypass procedure.
The 36 participating centers were asked to document 28 discrete process measures, starting with “did the patient stop smoking before surgery?” and ending with “did the patient have a follow-up clinic appointment scheduled?” Each one was entered by a trained clinical reviewer. The program included monthly audits for each participating center.
Data collection started on July 1, 2017, and continued to June 30, 2018, following a 6-month run-up period to allow centers to incorporate the measures.
The interim analysis presented included 4,700 patients who underwent procedures in the first 6 months of the data collection period. Nearly 60% (2,790 patients) had a laparoscopic sleeve gastrectomy, while about 40% (1,896 patients) underwent laparoscopic gastric bypass, and 0.1% (6 patients) had a band procedure.
Average length of stay was 1.76 days in the first 6 months of the pilot, down from 2.24 days in 2016 for those same participating centers (P less than .001), Dr. Brethauer reported.
Similarly, the rate of extended length of stay was 4.4% in the first 6 months of the pilot, down from 8.2% in 2016. Extended length of stay decreased with increasing adherence to the protocol, Dr. Brethauer and his colleagues found in their analysis.
Those length-of-stay reductions were accomplished with no increase in bleeding rates, all-cause reoperation rates, or readmissions. “We’re not doing this at the expense of other complications,” Dr. Brethauer said in a comment on the results.
Adherence to the 28 ENERGY measures increased from 26% in the first month of the pilot to 80.2% in March 2017, the latest month included in the interim analysis.
Opioid-sparing pain management strategies are incorporated into ENERGY. Over the first six months of the pilot, the average proportion of patients receiving no opioids postoperatively was 26.8%.
The ultimate goal of ENERGY is a large-scale rollout of enhanced recovery strategies, according to Dr. Brethauer.
ENERGY is the second national quality improvement project of the MBSAQIP. In the first, known as Decreasing Readmissions through Opportunities Provided (DROP), 128 U.S. hospitals implemented a set of standard processes organized into preoperative, inpatient, and postoperative care bundles. Results of a yearlong study of the DROP intervention demonstrated a significant reduction in 30-day all-cause hospital readmissions following sleeve gastrectomy.
“If you look at what’s happened in our specialty, and all the changes and all the work that’s been done, it’s really quite impressive,” Dr. Brethauer told attendees at the meeting. “It’s something that we’re very proud of. “
Dr. Brethauer reported disclosures related to Medtronic and Ethicon outside of the scope of this presentation.
ORLANDO – Adopting a 28-point significantly reduced length of stay without significant effects on complications or readmissions, according to interim results of a large, nationwide surgical quality initiative.
Thirty-six centers participated in this pilot initiative, making it one of the largest national projects focused on enhanced recovery to date, according to Stacy A. Brethauer, MD, FACS, cochair of the Quality and Data Committee of the Metabolic and Bariatric Surgery Accreditation Quality Improvement Program (MBSAQIP).
The initiative, known as Employing New Enhanced Recovery Goals for Bariatric Surgery (ENERGY), was developed in light of “huge gaps in literature and knowledge” about what best practices of enhanced recovery should look like for bariatric surgery, Dr. Brethauer said in a podium presentation at the American College of Surgeons Quality and Safety Conference.
“Bariatric surgery is very pathway driven, but the pathway can be very cumbersome and very antiquated if you don’t keep it up to date and evidence based,” said Dr. Brethauer, associate professor of surgery at the Cleveland Clinic.
Invitations to join in the ENERGY pilot were targeted to the 80 or so MBSAQIP-accredited centers in the top decile of programs for length of stay. “That’s the needle that we want to move,” Dr. Brethauer said.
ENERGY includes interventions in the preoperative, perioperative, and postoperative setting for each patient who undergoes a primary band, lap sleeve, or lap bypass procedure.
The 36 participating centers were asked to document 28 discrete process measures, starting with “did the patient stop smoking before surgery?” and ending with “did the patient have a follow-up clinic appointment scheduled?” Each one was entered by a trained clinical reviewer. The program included monthly audits for each participating center.
Data collection started on July 1, 2017, and continued to June 30, 2018, following a 6-month run-up period to allow centers to incorporate the measures.
The interim analysis presented included 4,700 patients who underwent procedures in the first 6 months of the data collection period. Nearly 60% (2,790 patients) had a laparoscopic sleeve gastrectomy, while about 40% (1,896 patients) underwent laparoscopic gastric bypass, and 0.1% (6 patients) had a band procedure.
Average length of stay was 1.76 days in the first 6 months of the pilot, down from 2.24 days in 2016 for those same participating centers (P less than .001), Dr. Brethauer reported.
Similarly, the rate of extended length of stay was 4.4% in the first 6 months of the pilot, down from 8.2% in 2016. Extended length of stay decreased with increasing adherence to the protocol, Dr. Brethauer and his colleagues found in their analysis.
Those length-of-stay reductions were accomplished with no increase in bleeding rates, all-cause reoperation rates, or readmissions. “We’re not doing this at the expense of other complications,” Dr. Brethauer said in a comment on the results.
Adherence to the 28 ENERGY measures increased from 26% in the first month of the pilot to 80.2% in March 2017, the latest month included in the interim analysis.
Opioid-sparing pain management strategies are incorporated into ENERGY. Over the first six months of the pilot, the average proportion of patients receiving no opioids postoperatively was 26.8%.
The ultimate goal of ENERGY is a large-scale rollout of enhanced recovery strategies, according to Dr. Brethauer.
ENERGY is the second national quality improvement project of the MBSAQIP. In the first, known as Decreasing Readmissions through Opportunities Provided (DROP), 128 U.S. hospitals implemented a set of standard processes organized into preoperative, inpatient, and postoperative care bundles. Results of a yearlong study of the DROP intervention demonstrated a significant reduction in 30-day all-cause hospital readmissions following sleeve gastrectomy.
“If you look at what’s happened in our specialty, and all the changes and all the work that’s been done, it’s really quite impressive,” Dr. Brethauer told attendees at the meeting. “It’s something that we’re very proud of. “
Dr. Brethauer reported disclosures related to Medtronic and Ethicon outside of the scope of this presentation.
ORLANDO – Adopting a 28-point significantly reduced length of stay without significant effects on complications or readmissions, according to interim results of a large, nationwide surgical quality initiative.
Thirty-six centers participated in this pilot initiative, making it one of the largest national projects focused on enhanced recovery to date, according to Stacy A. Brethauer, MD, FACS, cochair of the Quality and Data Committee of the Metabolic and Bariatric Surgery Accreditation Quality Improvement Program (MBSAQIP).
The initiative, known as Employing New Enhanced Recovery Goals for Bariatric Surgery (ENERGY), was developed in light of “huge gaps in literature and knowledge” about what best practices of enhanced recovery should look like for bariatric surgery, Dr. Brethauer said in a podium presentation at the American College of Surgeons Quality and Safety Conference.
“Bariatric surgery is very pathway driven, but the pathway can be very cumbersome and very antiquated if you don’t keep it up to date and evidence based,” said Dr. Brethauer, associate professor of surgery at the Cleveland Clinic.
Invitations to join in the ENERGY pilot were targeted to the 80 or so MBSAQIP-accredited centers in the top decile of programs for length of stay. “That’s the needle that we want to move,” Dr. Brethauer said.
ENERGY includes interventions in the preoperative, perioperative, and postoperative setting for each patient who undergoes a primary band, lap sleeve, or lap bypass procedure.
The 36 participating centers were asked to document 28 discrete process measures, starting with “did the patient stop smoking before surgery?” and ending with “did the patient have a follow-up clinic appointment scheduled?” Each one was entered by a trained clinical reviewer. The program included monthly audits for each participating center.
Data collection started on July 1, 2017, and continued to June 30, 2018, following a 6-month run-up period to allow centers to incorporate the measures.
The interim analysis presented included 4,700 patients who underwent procedures in the first 6 months of the data collection period. Nearly 60% (2,790 patients) had a laparoscopic sleeve gastrectomy, while about 40% (1,896 patients) underwent laparoscopic gastric bypass, and 0.1% (6 patients) had a band procedure.
Average length of stay was 1.76 days in the first 6 months of the pilot, down from 2.24 days in 2016 for those same participating centers (P less than .001), Dr. Brethauer reported.
Similarly, the rate of extended length of stay was 4.4% in the first 6 months of the pilot, down from 8.2% in 2016. Extended length of stay decreased with increasing adherence to the protocol, Dr. Brethauer and his colleagues found in their analysis.
Those length-of-stay reductions were accomplished with no increase in bleeding rates, all-cause reoperation rates, or readmissions. “We’re not doing this at the expense of other complications,” Dr. Brethauer said in a comment on the results.
Adherence to the 28 ENERGY measures increased from 26% in the first month of the pilot to 80.2% in March 2017, the latest month included in the interim analysis.
Opioid-sparing pain management strategies are incorporated into ENERGY. Over the first six months of the pilot, the average proportion of patients receiving no opioids postoperatively was 26.8%.
The ultimate goal of ENERGY is a large-scale rollout of enhanced recovery strategies, according to Dr. Brethauer.
ENERGY is the second national quality improvement project of the MBSAQIP. In the first, known as Decreasing Readmissions through Opportunities Provided (DROP), 128 U.S. hospitals implemented a set of standard processes organized into preoperative, inpatient, and postoperative care bundles. Results of a yearlong study of the DROP intervention demonstrated a significant reduction in 30-day all-cause hospital readmissions following sleeve gastrectomy.
“If you look at what’s happened in our specialty, and all the changes and all the work that’s been done, it’s really quite impressive,” Dr. Brethauer told attendees at the meeting. “It’s something that we’re very proud of. “
Dr. Brethauer reported disclosures related to Medtronic and Ethicon outside of the scope of this presentation.
REPORTING FROM ACSQSC 2018
Key clinical point: An evidence-based enhanced recovery protocol reduced length of stay for bariatric surgery patients.
Major finding: Average length of stay was 1.76 days in the first 6 months of the pilot, down from 2.24 days in 2016 for those same participating centers.
Study details: Data on 36 bariatric surgery centers and 4,700 patients who underwent procedures in the first 6 months of the data collection period.
Disclosures: Dr. Brethauer reported disclosures related to Medtronic and Ethicon outside of the scope of this presentation.
What underlies post–bariatric surgery bone fragility?
BOSTON – Charting a healthy path for patients after bariatric surgery can be complicated and addressing bone health is an important part of the endocrinologist’s role in keeping patients safe from postsurgical fractures, according to John Bilezikian, MD.
said Dr. Bilezikian, speaking during a bariatric surgery–focused session at the annual scientific & clinical congress of the American Academy of Clinical Endocrinologists.
It’s not easy to assess bone health, even before surgery, said Dr. Bilezikian. Even objective measures of bone density, such as dual-energy x-ray absorptiometry (DXA), may be skewed: very high fat mass causes artifact that interferes with accurate measurement of bone density, and DXA can’t distinguish between cortical and trabecular bone. The latter is a particular issue in high body mass index patients, since obesity is known to be associated with a more fragile bone microarchitecture, said Dr. Bilezikian, the Dorothy L. and Daniel H. Silberberg Professor of Medicine and director of the metabolic bone diseases unit at Columbia University, New York.
With these caveats in mind, Dr. Bilezikian said, there are some lessons to be learned from existing research to better manage bone health in bariatric patients.
After Roux-en-Y gastric bypass surgery (RYGB), bone turnover soon increases, with bone resorption markers increasing by up to 200% in the first 12-18 months after surgery. Bone formation markers also are elevated but to a lesser extent, said Dr. Bilezikian. Over time, the weight loss from RYGB is associated with a significant drop in bone mineral density (BMD) at weight-bearing sites. Weight loss was associated with bone loss at the total hip (r = 0.70; P less than .0003) and femoral neck (r = 0.47; P = .03 (J Clin Endocrinol Metab. 2013 Feb;98[2] 541-9).
A newer-technology, high-resolution peripheral quantitative CT (HR-pQCT) offers a noninvasive look not just at bone size and density but also at microarchitecture, including cortical thickness and details of trabecular structure. This technology “can help elucidate the structural basis for fragility,” said Dr. Bilezikian.
HR-pQCT was used in a recent study (J Bone Min Res. 2017 Dec. 27. doi: 10.1002/jbmr.3371) that followed 48 patients for 1 year after RYGB. Using HR-pQCT, DXA, and serum markers of bone turnover, the researchers found significant decrease in BMD and estimated decrease in bone strength after RYGB. Bone cortex became increasingly porous as well. Taken together, these changes may indicate an increased fracture risk, concluded the investigators.
A longer study that followed RYGB recipients for 2 years and used similar imaging and serum parameters also found that participants had decreased BMD. Tellingly, these investigators saw more marked increase in cortical porosity in the second year after bypass. Estimated bone strength continued to decline during the study period, even after weight loss had stopped.
All of these findings, said Dr. Bilezikian, point to a pathogenetic process other than weight loss that promotes the deteriorating bone microarchitecture seen years after RYGB. “Loss of bone mass and skeletal deterioration after gastric bypass surgery cannot be explained by weight loss alone,” said Dr. Bilezikian.
Another recent study was able to follow a small cohort of patients for a full 5 years, using DXA, lumbar CT, and Hr-pQCT. Though weight loss stabilized after 2 years and 25-OH D and calcium levels were unchanged from presurgical baseline, bone density continued to drop, and bone microarchitecture further deteriorated, said Dr. Bilezikian (Greenblatt L et al. ASBMR 2017, Abstract 1125).
Initially, post–bariatric surgery weight loss may induce bone changes because of skeletal unloading; further down the road, estrogen production by adipose tissue is decreased with ongoing fat loss, and sarcopenia may have an adverse effect on bone microarchitecture. Postsurgical malabsorption may also be an early mechanism of bone loss.
Other hormonal changes can include secondary hyperparathyroidism. Leptin, adiponectin, and peptide YY levels also may be altered.
Do these changes in BMD and bone architecture result in increased fracture risk? This question is difficult to answer, for the same reasons that other bariatric surgery research can be challenging, said Dr. Bilezikian. There is heterogeneity of procedures and supplement regimens, sample sizes can be small, follow-up times short, and adherence often is not tracked.
However, there are some clues that RYGB may be associated with an increased risk of all fractures and of fragility fractures, with appendicular fractures seen most frequently (Osteoporos Int. 2014 Jan; 25[1]:151-8). A larger study that tracked 12,676 patients receiving bariatric surgery, 38,028 patients with obesity, and 126,760 nonobese participants found that the bariatric patients had a 4.1% risk of fracture at 4 years post surgery, compared with 2.7% and 2.4% fracture rates in the participants with and without obesity, respectively (BMJ. 2016;354:i3794).
Other retrospective studies have found “a time-dependent increase in nonvertebral fractures with Roux-en-Y gastric bypass compared to gastric banding,” said Dr. Bilezikian.
How can these risks be managed after gastric bypass surgery? “Strive for nutritional adequacy” as the first step, said Dr. Bilezikian, meaning that calcium and vitamin D should be prescribed – and adherence encouraged – as indicated. Levels of 25-OH D should be checked regularly, with supplementation managed to keep levels over 30 ng/mL, he said.
All patients should be encouraged to develop and maintain an appropriate exercise regimen, and BMD should be followed over time. Those caring for post–gastric bypass patients can still use a bisphosphonate or other bone-health medication, if indicated using standard parameters. However, “You probably shouldn’t use an oral bisphosphonate in this population,” said Dr. Bilezikian.
Dr. Bilezikian reported that he has consulting or advisory relationships with Amgen, Radius Pharmaceuticals, Shire Pharmaceuticals, and Ultragenyx, and serves on a data safety monitoring board for Regeneron.
BOSTON – Charting a healthy path for patients after bariatric surgery can be complicated and addressing bone health is an important part of the endocrinologist’s role in keeping patients safe from postsurgical fractures, according to John Bilezikian, MD.
said Dr. Bilezikian, speaking during a bariatric surgery–focused session at the annual scientific & clinical congress of the American Academy of Clinical Endocrinologists.
It’s not easy to assess bone health, even before surgery, said Dr. Bilezikian. Even objective measures of bone density, such as dual-energy x-ray absorptiometry (DXA), may be skewed: very high fat mass causes artifact that interferes with accurate measurement of bone density, and DXA can’t distinguish between cortical and trabecular bone. The latter is a particular issue in high body mass index patients, since obesity is known to be associated with a more fragile bone microarchitecture, said Dr. Bilezikian, the Dorothy L. and Daniel H. Silberberg Professor of Medicine and director of the metabolic bone diseases unit at Columbia University, New York.
With these caveats in mind, Dr. Bilezikian said, there are some lessons to be learned from existing research to better manage bone health in bariatric patients.
After Roux-en-Y gastric bypass surgery (RYGB), bone turnover soon increases, with bone resorption markers increasing by up to 200% in the first 12-18 months after surgery. Bone formation markers also are elevated but to a lesser extent, said Dr. Bilezikian. Over time, the weight loss from RYGB is associated with a significant drop in bone mineral density (BMD) at weight-bearing sites. Weight loss was associated with bone loss at the total hip (r = 0.70; P less than .0003) and femoral neck (r = 0.47; P = .03 (J Clin Endocrinol Metab. 2013 Feb;98[2] 541-9).
A newer-technology, high-resolution peripheral quantitative CT (HR-pQCT) offers a noninvasive look not just at bone size and density but also at microarchitecture, including cortical thickness and details of trabecular structure. This technology “can help elucidate the structural basis for fragility,” said Dr. Bilezikian.
HR-pQCT was used in a recent study (J Bone Min Res. 2017 Dec. 27. doi: 10.1002/jbmr.3371) that followed 48 patients for 1 year after RYGB. Using HR-pQCT, DXA, and serum markers of bone turnover, the researchers found significant decrease in BMD and estimated decrease in bone strength after RYGB. Bone cortex became increasingly porous as well. Taken together, these changes may indicate an increased fracture risk, concluded the investigators.
A longer study that followed RYGB recipients for 2 years and used similar imaging and serum parameters also found that participants had decreased BMD. Tellingly, these investigators saw more marked increase in cortical porosity in the second year after bypass. Estimated bone strength continued to decline during the study period, even after weight loss had stopped.
All of these findings, said Dr. Bilezikian, point to a pathogenetic process other than weight loss that promotes the deteriorating bone microarchitecture seen years after RYGB. “Loss of bone mass and skeletal deterioration after gastric bypass surgery cannot be explained by weight loss alone,” said Dr. Bilezikian.
Another recent study was able to follow a small cohort of patients for a full 5 years, using DXA, lumbar CT, and Hr-pQCT. Though weight loss stabilized after 2 years and 25-OH D and calcium levels were unchanged from presurgical baseline, bone density continued to drop, and bone microarchitecture further deteriorated, said Dr. Bilezikian (Greenblatt L et al. ASBMR 2017, Abstract 1125).
Initially, post–bariatric surgery weight loss may induce bone changes because of skeletal unloading; further down the road, estrogen production by adipose tissue is decreased with ongoing fat loss, and sarcopenia may have an adverse effect on bone microarchitecture. Postsurgical malabsorption may also be an early mechanism of bone loss.
Other hormonal changes can include secondary hyperparathyroidism. Leptin, adiponectin, and peptide YY levels also may be altered.
Do these changes in BMD and bone architecture result in increased fracture risk? This question is difficult to answer, for the same reasons that other bariatric surgery research can be challenging, said Dr. Bilezikian. There is heterogeneity of procedures and supplement regimens, sample sizes can be small, follow-up times short, and adherence often is not tracked.
However, there are some clues that RYGB may be associated with an increased risk of all fractures and of fragility fractures, with appendicular fractures seen most frequently (Osteoporos Int. 2014 Jan; 25[1]:151-8). A larger study that tracked 12,676 patients receiving bariatric surgery, 38,028 patients with obesity, and 126,760 nonobese participants found that the bariatric patients had a 4.1% risk of fracture at 4 years post surgery, compared with 2.7% and 2.4% fracture rates in the participants with and without obesity, respectively (BMJ. 2016;354:i3794).
Other retrospective studies have found “a time-dependent increase in nonvertebral fractures with Roux-en-Y gastric bypass compared to gastric banding,” said Dr. Bilezikian.
How can these risks be managed after gastric bypass surgery? “Strive for nutritional adequacy” as the first step, said Dr. Bilezikian, meaning that calcium and vitamin D should be prescribed – and adherence encouraged – as indicated. Levels of 25-OH D should be checked regularly, with supplementation managed to keep levels over 30 ng/mL, he said.
All patients should be encouraged to develop and maintain an appropriate exercise regimen, and BMD should be followed over time. Those caring for post–gastric bypass patients can still use a bisphosphonate or other bone-health medication, if indicated using standard parameters. However, “You probably shouldn’t use an oral bisphosphonate in this population,” said Dr. Bilezikian.
Dr. Bilezikian reported that he has consulting or advisory relationships with Amgen, Radius Pharmaceuticals, Shire Pharmaceuticals, and Ultragenyx, and serves on a data safety monitoring board for Regeneron.
BOSTON – Charting a healthy path for patients after bariatric surgery can be complicated and addressing bone health is an important part of the endocrinologist’s role in keeping patients safe from postsurgical fractures, according to John Bilezikian, MD.
said Dr. Bilezikian, speaking during a bariatric surgery–focused session at the annual scientific & clinical congress of the American Academy of Clinical Endocrinologists.
It’s not easy to assess bone health, even before surgery, said Dr. Bilezikian. Even objective measures of bone density, such as dual-energy x-ray absorptiometry (DXA), may be skewed: very high fat mass causes artifact that interferes with accurate measurement of bone density, and DXA can’t distinguish between cortical and trabecular bone. The latter is a particular issue in high body mass index patients, since obesity is known to be associated with a more fragile bone microarchitecture, said Dr. Bilezikian, the Dorothy L. and Daniel H. Silberberg Professor of Medicine and director of the metabolic bone diseases unit at Columbia University, New York.
With these caveats in mind, Dr. Bilezikian said, there are some lessons to be learned from existing research to better manage bone health in bariatric patients.
After Roux-en-Y gastric bypass surgery (RYGB), bone turnover soon increases, with bone resorption markers increasing by up to 200% in the first 12-18 months after surgery. Bone formation markers also are elevated but to a lesser extent, said Dr. Bilezikian. Over time, the weight loss from RYGB is associated with a significant drop in bone mineral density (BMD) at weight-bearing sites. Weight loss was associated with bone loss at the total hip (r = 0.70; P less than .0003) and femoral neck (r = 0.47; P = .03 (J Clin Endocrinol Metab. 2013 Feb;98[2] 541-9).
A newer-technology, high-resolution peripheral quantitative CT (HR-pQCT) offers a noninvasive look not just at bone size and density but also at microarchitecture, including cortical thickness and details of trabecular structure. This technology “can help elucidate the structural basis for fragility,” said Dr. Bilezikian.
HR-pQCT was used in a recent study (J Bone Min Res. 2017 Dec. 27. doi: 10.1002/jbmr.3371) that followed 48 patients for 1 year after RYGB. Using HR-pQCT, DXA, and serum markers of bone turnover, the researchers found significant decrease in BMD and estimated decrease in bone strength after RYGB. Bone cortex became increasingly porous as well. Taken together, these changes may indicate an increased fracture risk, concluded the investigators.
A longer study that followed RYGB recipients for 2 years and used similar imaging and serum parameters also found that participants had decreased BMD. Tellingly, these investigators saw more marked increase in cortical porosity in the second year after bypass. Estimated bone strength continued to decline during the study period, even after weight loss had stopped.
All of these findings, said Dr. Bilezikian, point to a pathogenetic process other than weight loss that promotes the deteriorating bone microarchitecture seen years after RYGB. “Loss of bone mass and skeletal deterioration after gastric bypass surgery cannot be explained by weight loss alone,” said Dr. Bilezikian.
Another recent study was able to follow a small cohort of patients for a full 5 years, using DXA, lumbar CT, and Hr-pQCT. Though weight loss stabilized after 2 years and 25-OH D and calcium levels were unchanged from presurgical baseline, bone density continued to drop, and bone microarchitecture further deteriorated, said Dr. Bilezikian (Greenblatt L et al. ASBMR 2017, Abstract 1125).
Initially, post–bariatric surgery weight loss may induce bone changes because of skeletal unloading; further down the road, estrogen production by adipose tissue is decreased with ongoing fat loss, and sarcopenia may have an adverse effect on bone microarchitecture. Postsurgical malabsorption may also be an early mechanism of bone loss.
Other hormonal changes can include secondary hyperparathyroidism. Leptin, adiponectin, and peptide YY levels also may be altered.
Do these changes in BMD and bone architecture result in increased fracture risk? This question is difficult to answer, for the same reasons that other bariatric surgery research can be challenging, said Dr. Bilezikian. There is heterogeneity of procedures and supplement regimens, sample sizes can be small, follow-up times short, and adherence often is not tracked.
However, there are some clues that RYGB may be associated with an increased risk of all fractures and of fragility fractures, with appendicular fractures seen most frequently (Osteoporos Int. 2014 Jan; 25[1]:151-8). A larger study that tracked 12,676 patients receiving bariatric surgery, 38,028 patients with obesity, and 126,760 nonobese participants found that the bariatric patients had a 4.1% risk of fracture at 4 years post surgery, compared with 2.7% and 2.4% fracture rates in the participants with and without obesity, respectively (BMJ. 2016;354:i3794).
Other retrospective studies have found “a time-dependent increase in nonvertebral fractures with Roux-en-Y gastric bypass compared to gastric banding,” said Dr. Bilezikian.
How can these risks be managed after gastric bypass surgery? “Strive for nutritional adequacy” as the first step, said Dr. Bilezikian, meaning that calcium and vitamin D should be prescribed – and adherence encouraged – as indicated. Levels of 25-OH D should be checked regularly, with supplementation managed to keep levels over 30 ng/mL, he said.
All patients should be encouraged to develop and maintain an appropriate exercise regimen, and BMD should be followed over time. Those caring for post–gastric bypass patients can still use a bisphosphonate or other bone-health medication, if indicated using standard parameters. However, “You probably shouldn’t use an oral bisphosphonate in this population,” said Dr. Bilezikian.
Dr. Bilezikian reported that he has consulting or advisory relationships with Amgen, Radius Pharmaceuticals, Shire Pharmaceuticals, and Ultragenyx, and serves on a data safety monitoring board for Regeneron.
REPORTING FROM AACE 2018