Shrabasti Bhattacharya

TOPLINE:

Whether they have normal weight, overweight, or obesity, individuals with metabolically healthy (MH) phenotypes show a lower frequency of impaired glucose metabolism than their unhealthy counterparts across all weight categories.

METHODOLOGY:

• The concepts of MH overweight and MH obesity refer to a subset of people who exhibit an absence of cardiometabolic risk factors despite excess body fat, but the prevalence of prediabetes has not been investigated by metabolic phenotype and body mass index (BMI).
• This study first validated the use of estimated glucose disposal rate (eGDR), an index of insulin sensitivity calculated from clinical variables, in 350 individuals without diabetes (mean age, 37 years; 219 women; mean BMI, 30.3) from the EUGENE2 project who had varying glucose tolerance values originally assessed by insulin-stimulated glucose disposal.
• Researchers then stratified 2201 participants without diabetes (mean age, 46 years; White; 1290 women; mean BMI, 31.2) from the CATAMERI study according to BMI into three groups — individuals with normal weight (BMI, 18-24.9), overweight (BMI, 25-29.9), and obesity (BMI, ≥ 30).
• The men and women in each BMI group were separated into quartiles of insulin sensitivity based on eGDR index:
• In the normal weight group, men and women were defined as MH in the top three eGDR quartiles and metabolically unhealthy (MU) in the lowest quartile.
• In the overweight and obesity groups, people were defined as MH in the top eGDR quartile and MU in the lower three quartiles.
• Impaired glucose tolerance (IGT), impaired fasting glucose (IFG), and combined IFG+IGT conditions (from an oral glucose tolerance test) were compared in individuals without diabetes based on MH or unhealthy phenotypes across normal weight, overweight, and obese categories.

TAKEAWAY:

• eGDR demonstrated good accuracy in detecting individuals with higher insulin sensitivity in the EUGENE2 cohort.
• The MH overweight and MH obesity groups showed comparable glycemic parameters as the MH normal weight group, whereas the MU overweight and MU obesity groups exhibited higher A1c levels and fasting and 2-hour post-load glucose than the MH normal weight group.
• The frequencies of IFG, IGT, and IFG+IGT conditions were similar among the MH normal weight, MH overweight, and MH obesity groups but were higher in the MU overweight and MU obesity groups than in the MU normal weight group.
• Furthermore, compared with those in the MH normal weight group, the odds of prediabetes were at least two times higher in the MU obesity (odds ratio [OR], 2.54; P < .001) and MU overweight (OR, 2.06; P < .001) groups but not significantly different in the MU normal weight, MH obesity, and MH overweight groups.

IN PRACTICE:

The authors wrote, “Overall, the results of this cross-sectional study support the notion that metabolically healthy individuals with overweight or obesity have a more favorable metabolic risk profile in comparison to metabolically unhealthy subjects with overweight or obesity.”

SOURCE:

The study was conducted by Chiara M.A. Cefalo, MD, department of clinical and molecular medicine, Sapienza University of Rome, Rome, Italy, and was published online in Diabetes, Obesity and Metabolism.

LIMITATIONS:

There was no consensus on the parameters and cutoff values for defining metabolic health status, allowing for potential variations in results. The study design suggested an association with prevalent IFG and IGT conditions but not with incident IFG and IGT conditions. All participants in this study were White, limiting the generalizability of its findings.

DISCLOSURES:

The study was supported by Sapienza University of Rome and the Italian Ministry of University. The authors declared no conflicts of interest.

A version of this article first appeared on Medscape.com.

TOPLINE:

Whether they have normal weight, overweight, or obesity, individuals with metabolically healthy (MH) phenotypes show a lower frequency of impaired glucose metabolism than their unhealthy counterparts across all weight categories.

METHODOLOGY:

• The concepts of MH overweight and MH obesity refer to a subset of people who exhibit an absence of cardiometabolic risk factors despite excess body fat, but the prevalence of prediabetes has not been investigated by metabolic phenotype and body mass index (BMI).
• This study first validated the use of estimated glucose disposal rate (eGDR), an index of insulin sensitivity calculated from clinical variables, in 350 individuals without diabetes (mean age, 37 years; 219 women; mean BMI, 30.3) from the EUGENE2 project who had varying glucose tolerance values originally assessed by insulin-stimulated glucose disposal.
• Researchers then stratified 2201 participants without diabetes (mean age, 46 years; White; 1290 women; mean BMI, 31.2) from the CATAMERI study according to BMI into three groups — individuals with normal weight (BMI, 18-24.9), overweight (BMI, 25-29.9), and obesity (BMI, ≥ 30).
• The men and women in each BMI group were separated into quartiles of insulin sensitivity based on eGDR index:
• In the normal weight group, men and women were defined as MH in the top three eGDR quartiles and metabolically unhealthy (MU) in the lowest quartile.
• In the overweight and obesity groups, people were defined as MH in the top eGDR quartile and MU in the lower three quartiles.
• Impaired glucose tolerance (IGT), impaired fasting glucose (IFG), and combined IFG+IGT conditions (from an oral glucose tolerance test) were compared in individuals without diabetes based on MH or unhealthy phenotypes across normal weight, overweight, and obese categories.

TAKEAWAY:

• eGDR demonstrated good accuracy in detecting individuals with higher insulin sensitivity in the EUGENE2 cohort.
• The MH overweight and MH obesity groups showed comparable glycemic parameters as the MH normal weight group, whereas the MU overweight and MU obesity groups exhibited higher A1c levels and fasting and 2-hour post-load glucose than the MH normal weight group.
• The frequencies of IFG, IGT, and IFG+IGT conditions were similar among the MH normal weight, MH overweight, and MH obesity groups but were higher in the MU overweight and MU obesity groups than in the MU normal weight group.
• Furthermore, compared with those in the MH normal weight group, the odds of prediabetes were at least two times higher in the MU obesity (odds ratio [OR], 2.54; P < .001) and MU overweight (OR, 2.06; P < .001) groups but not significantly different in the MU normal weight, MH obesity, and MH overweight groups.

IN PRACTICE:

The authors wrote, “Overall, the results of this cross-sectional study support the notion that metabolically healthy individuals with overweight or obesity have a more favorable metabolic risk profile in comparison to metabolically unhealthy subjects with overweight or obesity.”

SOURCE:

The study was conducted by Chiara M.A. Cefalo, MD, department of clinical and molecular medicine, Sapienza University of Rome, Rome, Italy, and was published online in Diabetes, Obesity and Metabolism.

LIMITATIONS:

There was no consensus on the parameters and cutoff values for defining metabolic health status, allowing for potential variations in results. The study design suggested an association with prevalent IFG and IGT conditions but not with incident IFG and IGT conditions. All participants in this study were White, limiting the generalizability of its findings.

DISCLOSURES:

The study was supported by Sapienza University of Rome and the Italian Ministry of University. The authors declared no conflicts of interest.

A version of this article first appeared on Medscape.com.

TOPLINE:

Whether they have normal weight, overweight, or obesity, individuals with metabolically healthy (MH) phenotypes show a lower frequency of impaired glucose metabolism than their unhealthy counterparts across all weight categories.

METHODOLOGY:

• The concepts of MH overweight and MH obesity refer to a subset of people who exhibit an absence of cardiometabolic risk factors despite excess body fat, but the prevalence of prediabetes has not been investigated by metabolic phenotype and body mass index (BMI).
• This study first validated the use of estimated glucose disposal rate (eGDR), an index of insulin sensitivity calculated from clinical variables, in 350 individuals without diabetes (mean age, 37 years; 219 women; mean BMI, 30.3) from the EUGENE2 project who had varying glucose tolerance values originally assessed by insulin-stimulated glucose disposal.
• Researchers then stratified 2201 participants without diabetes (mean age, 46 years; White; 1290 women; mean BMI, 31.2) from the CATAMERI study according to BMI into three groups — individuals with normal weight (BMI, 18-24.9), overweight (BMI, 25-29.9), and obesity (BMI, ≥ 30).
• The men and women in each BMI group were separated into quartiles of insulin sensitivity based on eGDR index:
• In the normal weight group, men and women were defined as MH in the top three eGDR quartiles and metabolically unhealthy (MU) in the lowest quartile.
• In the overweight and obesity groups, people were defined as MH in the top eGDR quartile and MU in the lower three quartiles.
• Impaired glucose tolerance (IGT), impaired fasting glucose (IFG), and combined IFG+IGT conditions (from an oral glucose tolerance test) were compared in individuals without diabetes based on MH or unhealthy phenotypes across normal weight, overweight, and obese categories.

TAKEAWAY:

• eGDR demonstrated good accuracy in detecting individuals with higher insulin sensitivity in the EUGENE2 cohort.
• The MH overweight and MH obesity groups showed comparable glycemic parameters as the MH normal weight group, whereas the MU overweight and MU obesity groups exhibited higher A1c levels and fasting and 2-hour post-load glucose than the MH normal weight group.
• The frequencies of IFG, IGT, and IFG+IGT conditions were similar among the MH normal weight, MH overweight, and MH obesity groups but were higher in the MU overweight and MU obesity groups than in the MU normal weight group.
• Furthermore, compared with those in the MH normal weight group, the odds of prediabetes were at least two times higher in the MU obesity (odds ratio [OR], 2.54; P < .001) and MU overweight (OR, 2.06; P < .001) groups but not significantly different in the MU normal weight, MH obesity, and MH overweight groups.

IN PRACTICE:

The authors wrote, “Overall, the results of this cross-sectional study support the notion that metabolically healthy individuals with overweight or obesity have a more favorable metabolic risk profile in comparison to metabolically unhealthy subjects with overweight or obesity.”

SOURCE:

The study was conducted by Chiara M.A. Cefalo, MD, department of clinical and molecular medicine, Sapienza University of Rome, Rome, Italy, and was published online in Diabetes, Obesity and Metabolism.

LIMITATIONS:

There was no consensus on the parameters and cutoff values for defining metabolic health status, allowing for potential variations in results. The study design suggested an association with prevalent IFG and IGT conditions but not with incident IFG and IGT conditions. All participants in this study were White, limiting the generalizability of its findings.

DISCLOSURES:

The study was supported by Sapienza University of Rome and the Italian Ministry of University. The authors declared no conflicts of interest.

A version of this article first appeared on Medscape.com.

TOPLINE:

Consuming ultraprocessed food (UPF) and minimally processed food (MPF) is linked to higher and lower odds of constipation, respectively, with the effect of food processing independent of diet quality.

METHODOLOGY:

• Excess consumption of UPF has been linked to disturbed intestinal motility.
• Using data from the National Health and Nutrition Examination Survey (2005-2010), researchers performed a cross-sectional study to assess the association between UPF and MPF intake and bowel habits.
• They used two 24-hour dietary recalls to capture the participants’ dietary intake and subsequently categorized food items into MPF, processed culinary ingredients, processed food, and UPF, according to the Nova classification.
• The Bowel Health Questionnaire was used to assess bowel habits, with constipation and diarrhea being defined according to the Bristol Stool Form Scale and stool frequency.
• The odds ratios for constipation and diarrhea were calculated by comparing the quartiles of UPF and MPF consumption using survey-weighted logistic regressions adjusted for potential confounding factors.

TAKEAWAY:

• Researchers included 12,716 US adults, of whom 1290 and 1067 had constipation and diarrhea, respectively.
• Increased consumption of UPF was associated with more than two times increased odds of constipation; the association held after adjusting for diet quality, water intake, and fiber intake.
• Conversely, increased intake of MPF was associated with reduced odds of constipation; the association held after adjustment.
• Substituting 10% of UPF with an equivalent proportion of MPF was associated with 10% lower odds of constipation.
• Neither MPF nor UPF consumption was associated with increased odds of diarrhea.

IN PRACTICE:

“The persistently strong associations with [UPF] and MPF consumption despite adjustment for diet quality suggest that food processing plays a unique role in constipation,” the authors wrote.

SOURCE:

The study, led by Chun-Han Lo, MD, MPH, Department of Internal Medicine, Kirk Kerkorian School of Medicine at the University of Nevada, Las Vegas, was published online in Clinical Gastroenterology and Hepatology.

LIMITATIONS:

The evaluation of dietary intake using two 24-hour dietary recalls did not allow for the assessment of dietary changes over time. Misclassification bias could be present due to varying degrees of food processing across different brands. The authors could not fully account for unmeasured confounders owing to the observational nature of this study.

DISCLOSURES:

This study did not receive any funding. Some authors declared serving as consultants, being on advisory boards, or receiving research funding from various sources.

A version of this article first appeared on Medscape.com.

TOPLINE:

Consuming ultraprocessed food (UPF) and minimally processed food (MPF) is linked to higher and lower odds of constipation, respectively, with the effect of food processing independent of diet quality.

METHODOLOGY:

• Excess consumption of UPF has been linked to disturbed intestinal motility.
• Using data from the National Health and Nutrition Examination Survey (2005-2010), researchers performed a cross-sectional study to assess the association between UPF and MPF intake and bowel habits.
• They used two 24-hour dietary recalls to capture the participants’ dietary intake and subsequently categorized food items into MPF, processed culinary ingredients, processed food, and UPF, according to the Nova classification.
• The Bowel Health Questionnaire was used to assess bowel habits, with constipation and diarrhea being defined according to the Bristol Stool Form Scale and stool frequency.
• The odds ratios for constipation and diarrhea were calculated by comparing the quartiles of UPF and MPF consumption using survey-weighted logistic regressions adjusted for potential confounding factors.

TAKEAWAY:

• Researchers included 12,716 US adults, of whom 1290 and 1067 had constipation and diarrhea, respectively.
• Increased consumption of UPF was associated with more than two times increased odds of constipation; the association held after adjusting for diet quality, water intake, and fiber intake.
• Conversely, increased intake of MPF was associated with reduced odds of constipation; the association held after adjustment.
• Substituting 10% of UPF with an equivalent proportion of MPF was associated with 10% lower odds of constipation.
• Neither MPF nor UPF consumption was associated with increased odds of diarrhea.

IN PRACTICE:

“The persistently strong associations with [UPF] and MPF consumption despite adjustment for diet quality suggest that food processing plays a unique role in constipation,” the authors wrote.

SOURCE:

The study, led by Chun-Han Lo, MD, MPH, Department of Internal Medicine, Kirk Kerkorian School of Medicine at the University of Nevada, Las Vegas, was published online in Clinical Gastroenterology and Hepatology.

LIMITATIONS:

The evaluation of dietary intake using two 24-hour dietary recalls did not allow for the assessment of dietary changes over time. Misclassification bias could be present due to varying degrees of food processing across different brands. The authors could not fully account for unmeasured confounders owing to the observational nature of this study.

DISCLOSURES:

This study did not receive any funding. Some authors declared serving as consultants, being on advisory boards, or receiving research funding from various sources.

A version of this article first appeared on Medscape.com.

TOPLINE:

Consuming ultraprocessed food (UPF) and minimally processed food (MPF) is linked to higher and lower odds of constipation, respectively, with the effect of food processing independent of diet quality.

METHODOLOGY:

• Excess consumption of UPF has been linked to disturbed intestinal motility.
• Using data from the National Health and Nutrition Examination Survey (2005-2010), researchers performed a cross-sectional study to assess the association between UPF and MPF intake and bowel habits.
• They used two 24-hour dietary recalls to capture the participants’ dietary intake and subsequently categorized food items into MPF, processed culinary ingredients, processed food, and UPF, according to the Nova classification.
• The Bowel Health Questionnaire was used to assess bowel habits, with constipation and diarrhea being defined according to the Bristol Stool Form Scale and stool frequency.
• The odds ratios for constipation and diarrhea were calculated by comparing the quartiles of UPF and MPF consumption using survey-weighted logistic regressions adjusted for potential confounding factors.

TAKEAWAY:

• Researchers included 12,716 US adults, of whom 1290 and 1067 had constipation and diarrhea, respectively.
• Increased consumption of UPF was associated with more than two times increased odds of constipation; the association held after adjusting for diet quality, water intake, and fiber intake.
• Conversely, increased intake of MPF was associated with reduced odds of constipation; the association held after adjustment.
• Substituting 10% of UPF with an equivalent proportion of MPF was associated with 10% lower odds of constipation.
• Neither MPF nor UPF consumption was associated with increased odds of diarrhea.

IN PRACTICE:

“The persistently strong associations with [UPF] and MPF consumption despite adjustment for diet quality suggest that food processing plays a unique role in constipation,” the authors wrote.

SOURCE:

The study, led by Chun-Han Lo, MD, MPH, Department of Internal Medicine, Kirk Kerkorian School of Medicine at the University of Nevada, Las Vegas, was published online in Clinical Gastroenterology and Hepatology.

LIMITATIONS:

The evaluation of dietary intake using two 24-hour dietary recalls did not allow for the assessment of dietary changes over time. Misclassification bias could be present due to varying degrees of food processing across different brands. The authors could not fully account for unmeasured confounders owing to the observational nature of this study.

DISCLOSURES:

This study did not receive any funding. Some authors declared serving as consultants, being on advisory boards, or receiving research funding from various sources.

A version of this article first appeared on Medscape.com.

TOPLINE:

Bimekizumab, currently approved for treating psoriasis, was well tolerated and reduced abscesses and the number of inflammatory nodules in patients with moderate to severe hidradenitis suppurativa (HS), in two phase 3 studies.

METHODOLOGY:

• To assess the efficacy and safety of bimekizumab, an interleukin (IL)-17A and IL-17F antagonist, 320 mg for HS, researchers conducted two 48-week phase 3 trials BE HEARD I (n = 505) and II (n = 509), which enrolled patients with moderate to severe HS and a history of inadequate response to systemic antibiotics.
• Patients were randomly assigned to one of four groups: Bimekizumab every 2 weeks, bimekizumab every 2 weeks for 16 weeks followed by every 4 weeks of dosing, bimekizumab every 4 weeks, or placebo for 16 weeks followed by bimekizumab every 2 weeks.
• The primary outcome was an HS clinical response of at least 50% (HiSCR50) at week 16, defined as at least a 50% reduction in total abscess and inflammatory nodule count.

TAKEAWAY:

• A higher proportion of patients receiving bimekizumab every 2 weeks vs placebo achieved an HiSCR50 response at week 16 in BE HEARD I (48% vs 29%; odds ratio [OR], 2.23; P = .006) and II (52% vs 32%; OR, 2.29; P = .0032) trials.
• Patients receiving bimekizumab every 4 weeks also achieved a higher HiSCR50 response at week 16 vs placebo in the BE HEARD II trial (54% vs 32%; OR, 2.42; P = .0038).
• At week 16, a higher proportion of patients receiving bimekizumab every 2 weeks vs placebo achieved at least a 75% HiSCR (HiSCR75) in both trials, and a higher proportion of those receiving bimekizumab every 4 weeks achieved HiSCR75 in the BE HEARD II trial.
• At week 48, 45%-68% of patients achieved HiSCR50 in both trials.
• Patients who received bimekizumab vs placebo for the initial 16 weeks had greater improvements in patient-reported outcomes, and bimekizumab was well tolerated with a low number of serious or severe treatment-emergent adverse events.

IN PRACTICE:

“Bimekizumab was well tolerated by patients with hidradenitis suppurativa and produced rapid and deep clinically meaningful responses that were maintained up to 48 weeks,” the authors wrote. “These data support the use of bimekizumab as a promising new therapeutic option for patients with moderate to severe hidradenitis suppurativa.”

[embed:render:related:node:269278]

SOURCE:

Alexa B. Kimball, MD, MPH, from Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, led this study, which was published online in The Lancet.

LIMITATIONS:

The placebo-controlled part of this trial was relatively short at 16 weeks and may affect the interpretation of later efficacy data, there was a lack of an active comparator group, and the efficacy of treatment was evaluated in the presence of rescue treatment with systemic antibiotics.

DISCLOSURES:

The studies were funded by bimekizumab manufacturer UCB Pharma. Seven authors disclosed being current or former employees of UCB Pharma. Other authors reported several ties with many companies, including UCB Pharma.

A version of this article first appeared on Medscape.com.

TOPLINE:

Bimekizumab, currently approved for treating psoriasis, was well tolerated and reduced abscesses and the number of inflammatory nodules in patients with moderate to severe hidradenitis suppurativa (HS), in two phase 3 studies.

METHODOLOGY:

• To assess the efficacy and safety of bimekizumab, an interleukin (IL)-17A and IL-17F antagonist, 320 mg for HS, researchers conducted two 48-week phase 3 trials BE HEARD I (n = 505) and II (n = 509), which enrolled patients with moderate to severe HS and a history of inadequate response to systemic antibiotics.
• Patients were randomly assigned to one of four groups: Bimekizumab every 2 weeks, bimekizumab every 2 weeks for 16 weeks followed by every 4 weeks of dosing, bimekizumab every 4 weeks, or placebo for 16 weeks followed by bimekizumab every 2 weeks.
• The primary outcome was an HS clinical response of at least 50% (HiSCR50) at week 16, defined as at least a 50% reduction in total abscess and inflammatory nodule count.

TAKEAWAY:

• A higher proportion of patients receiving bimekizumab every 2 weeks vs placebo achieved an HiSCR50 response at week 16 in BE HEARD I (48% vs 29%; odds ratio [OR], 2.23; P = .006) and II (52% vs 32%; OR, 2.29; P = .0032) trials.
• Patients receiving bimekizumab every 4 weeks also achieved a higher HiSCR50 response at week 16 vs placebo in the BE HEARD II trial (54% vs 32%; OR, 2.42; P = .0038).
• At week 16, a higher proportion of patients receiving bimekizumab every 2 weeks vs placebo achieved at least a 75% HiSCR (HiSCR75) in both trials, and a higher proportion of those receiving bimekizumab every 4 weeks achieved HiSCR75 in the BE HEARD II trial.
• At week 48, 45%-68% of patients achieved HiSCR50 in both trials.
• Patients who received bimekizumab vs placebo for the initial 16 weeks had greater improvements in patient-reported outcomes, and bimekizumab was well tolerated with a low number of serious or severe treatment-emergent adverse events.

IN PRACTICE:

“Bimekizumab was well tolerated by patients with hidradenitis suppurativa and produced rapid and deep clinically meaningful responses that were maintained up to 48 weeks,” the authors wrote. “These data support the use of bimekizumab as a promising new therapeutic option for patients with moderate to severe hidradenitis suppurativa.”

[embed:render:related:node:269278]

SOURCE:

Alexa B. Kimball, MD, MPH, from Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, led this study, which was published online in The Lancet.

LIMITATIONS:

The placebo-controlled part of this trial was relatively short at 16 weeks and may affect the interpretation of later efficacy data, there was a lack of an active comparator group, and the efficacy of treatment was evaluated in the presence of rescue treatment with systemic antibiotics.

DISCLOSURES:

The studies were funded by bimekizumab manufacturer UCB Pharma. Seven authors disclosed being current or former employees of UCB Pharma. Other authors reported several ties with many companies, including UCB Pharma.

A version of this article first appeared on Medscape.com.

TOPLINE:

Bimekizumab, currently approved for treating psoriasis, was well tolerated and reduced abscesses and the number of inflammatory nodules in patients with moderate to severe hidradenitis suppurativa (HS), in two phase 3 studies.

METHODOLOGY:

• To assess the efficacy and safety of bimekizumab, an interleukin (IL)-17A and IL-17F antagonist, 320 mg for HS, researchers conducted two 48-week phase 3 trials BE HEARD I (n = 505) and II (n = 509), which enrolled patients with moderate to severe HS and a history of inadequate response to systemic antibiotics.
• Patients were randomly assigned to one of four groups: Bimekizumab every 2 weeks, bimekizumab every 2 weeks for 16 weeks followed by every 4 weeks of dosing, bimekizumab every 4 weeks, or placebo for 16 weeks followed by bimekizumab every 2 weeks.
• The primary outcome was an HS clinical response of at least 50% (HiSCR50) at week 16, defined as at least a 50% reduction in total abscess and inflammatory nodule count.

TAKEAWAY:

• A higher proportion of patients receiving bimekizumab every 2 weeks vs placebo achieved an HiSCR50 response at week 16 in BE HEARD I (48% vs 29%; odds ratio [OR], 2.23; P = .006) and II (52% vs 32%; OR, 2.29; P = .0032) trials.
• Patients receiving bimekizumab every 4 weeks also achieved a higher HiSCR50 response at week 16 vs placebo in the BE HEARD II trial (54% vs 32%; OR, 2.42; P = .0038).
• At week 16, a higher proportion of patients receiving bimekizumab every 2 weeks vs placebo achieved at least a 75% HiSCR (HiSCR75) in both trials, and a higher proportion of those receiving bimekizumab every 4 weeks achieved HiSCR75 in the BE HEARD II trial.
• At week 48, 45%-68% of patients achieved HiSCR50 in both trials.
• Patients who received bimekizumab vs placebo for the initial 16 weeks had greater improvements in patient-reported outcomes, and bimekizumab was well tolerated with a low number of serious or severe treatment-emergent adverse events.

IN PRACTICE:

“Bimekizumab was well tolerated by patients with hidradenitis suppurativa and produced rapid and deep clinically meaningful responses that were maintained up to 48 weeks,” the authors wrote. “These data support the use of bimekizumab as a promising new therapeutic option for patients with moderate to severe hidradenitis suppurativa.”

[embed:render:related:node:269278]

SOURCE:

Alexa B. Kimball, MD, MPH, from Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, led this study, which was published online in The Lancet.

LIMITATIONS:

The placebo-controlled part of this trial was relatively short at 16 weeks and may affect the interpretation of later efficacy data, there was a lack of an active comparator group, and the efficacy of treatment was evaluated in the presence of rescue treatment with systemic antibiotics.

DISCLOSURES:

The studies were funded by bimekizumab manufacturer UCB Pharma. Seven authors disclosed being current or former employees of UCB Pharma. Other authors reported several ties with many companies, including UCB Pharma.

A version of this article first appeared on Medscape.com.

TOPLINE:

Inebilizumab-cdon, a monoclonal antibody that depletes B cells, reduces the risk for flares without showing any new safety signals in patients with immunoglobulin G4-related disease (IgG4-RD) who have multiorgan disease and are on glucocorticoid therapy.

METHODOLOGY:

• IgG4-RD is an immune-mediated, fibroinflammatory condition that affects multiple organs, causing irreversible organ damage. MITIGATE is the first multinational, placebo-controlled trial involving patients with IgG4-RD.
• Researchers evaluated the efficacy and safety of inebilizumab in 135 adult patients at risk for flares due to a history of multiorgan disease and active disease requiring treatment with glucocorticoids.
• The patients were randomly assigned to receive 300-mg intravenous inebilizumab or placebo on day 1, day 15, and week 26.
• The primary endpoint was the time to the first treated and adjudicated IgG4-RD flare within 52 weeks.
• The secondary endpoints included the annualized flare rate, flare-free and treatment-free complete remission, and flare-free and corticosteroid-free complete remission.

TAKEAWAY:

• Compared with the placebo, inebilizumab reduced the risk for IgG4-RD flares by 87% during the 52-week trial period (hazard ratio, 0.13; P < .0001).
• All the secondary endpoints showed improvement following treatment with inebilizumab.
• The most common adverse reactions with inebilizumab, as observed in a previous trial for neuromyelitis optica spectrum disorder, were urinary tract infection and arthralgia.
• There were no new safety signals in the MITIGATE trial.

IN PRACTICE:

“These data mark a major milestone for the IgG4-RD community and provide substantial insight into not only how inebilizumab can help manage IgG4-RD but also key insights into the nature of this condition,” John Stone, MD, MPH, principal investigator, said in a news release.

SOURCE:

Dr. Stone, a professor of medicine at the Harvard Medical School and the Edward A. Fox Chair in Medicine at the Massachusetts General Hospital, Boston, led this study.

LIMITATIONS:

This press release did not discuss any limitations of the current study.

DISCLOSURES:

This study was funded by Mitsubishi Tanabe Pharma and Hansoh Pharma and sponsored by Amgen. The author disclosures were not available.

A version of this article appeared on Medscape.com.

TOPLINE:

Inebilizumab-cdon, a monoclonal antibody that depletes B cells, reduces the risk for flares without showing any new safety signals in patients with immunoglobulin G4-related disease (IgG4-RD) who have multiorgan disease and are on glucocorticoid therapy.

METHODOLOGY:

• IgG4-RD is an immune-mediated, fibroinflammatory condition that affects multiple organs, causing irreversible organ damage. MITIGATE is the first multinational, placebo-controlled trial involving patients with IgG4-RD.
• Researchers evaluated the efficacy and safety of inebilizumab in 135 adult patients at risk for flares due to a history of multiorgan disease and active disease requiring treatment with glucocorticoids.
• The patients were randomly assigned to receive 300-mg intravenous inebilizumab or placebo on day 1, day 15, and week 26.
• The primary endpoint was the time to the first treated and adjudicated IgG4-RD flare within 52 weeks.
• The secondary endpoints included the annualized flare rate, flare-free and treatment-free complete remission, and flare-free and corticosteroid-free complete remission.

TAKEAWAY:

• Compared with the placebo, inebilizumab reduced the risk for IgG4-RD flares by 87% during the 52-week trial period (hazard ratio, 0.13; P < .0001).
• All the secondary endpoints showed improvement following treatment with inebilizumab.
• The most common adverse reactions with inebilizumab, as observed in a previous trial for neuromyelitis optica spectrum disorder, were urinary tract infection and arthralgia.
• There were no new safety signals in the MITIGATE trial.

IN PRACTICE:

“These data mark a major milestone for the IgG4-RD community and provide substantial insight into not only how inebilizumab can help manage IgG4-RD but also key insights into the nature of this condition,” John Stone, MD, MPH, principal investigator, said in a news release.

SOURCE:

Dr. Stone, a professor of medicine at the Harvard Medical School and the Edward A. Fox Chair in Medicine at the Massachusetts General Hospital, Boston, led this study.

LIMITATIONS:

This press release did not discuss any limitations of the current study.

DISCLOSURES:

This study was funded by Mitsubishi Tanabe Pharma and Hansoh Pharma and sponsored by Amgen. The author disclosures were not available.

A version of this article appeared on Medscape.com.

TOPLINE:

Inebilizumab-cdon, a monoclonal antibody that depletes B cells, reduces the risk for flares without showing any new safety signals in patients with immunoglobulin G4-related disease (IgG4-RD) who have multiorgan disease and are on glucocorticoid therapy.

METHODOLOGY:

• IgG4-RD is an immune-mediated, fibroinflammatory condition that affects multiple organs, causing irreversible organ damage. MITIGATE is the first multinational, placebo-controlled trial involving patients with IgG4-RD.
• Researchers evaluated the efficacy and safety of inebilizumab in 135 adult patients at risk for flares due to a history of multiorgan disease and active disease requiring treatment with glucocorticoids.
• The patients were randomly assigned to receive 300-mg intravenous inebilizumab or placebo on day 1, day 15, and week 26.
• The primary endpoint was the time to the first treated and adjudicated IgG4-RD flare within 52 weeks.
• The secondary endpoints included the annualized flare rate, flare-free and treatment-free complete remission, and flare-free and corticosteroid-free complete remission.

TAKEAWAY:

• Compared with the placebo, inebilizumab reduced the risk for IgG4-RD flares by 87% during the 52-week trial period (hazard ratio, 0.13; P < .0001).
• All the secondary endpoints showed improvement following treatment with inebilizumab.
• The most common adverse reactions with inebilizumab, as observed in a previous trial for neuromyelitis optica spectrum disorder, were urinary tract infection and arthralgia.
• There were no new safety signals in the MITIGATE trial.

IN PRACTICE:

“These data mark a major milestone for the IgG4-RD community and provide substantial insight into not only how inebilizumab can help manage IgG4-RD but also key insights into the nature of this condition,” John Stone, MD, MPH, principal investigator, said in a news release.

SOURCE:

Dr. Stone, a professor of medicine at the Harvard Medical School and the Edward A. Fox Chair in Medicine at the Massachusetts General Hospital, Boston, led this study.

LIMITATIONS:

This press release did not discuss any limitations of the current study.

DISCLOSURES:

This study was funded by Mitsubishi Tanabe Pharma and Hansoh Pharma and sponsored by Amgen. The author disclosures were not available.

A version of this article appeared on Medscape.com.

TOPLINE:

Metformin use lowers the risk for gout by 32% in individuals with prediabetes; however, the treatment doesn’t change serum urate or C-reactive protein levels.

METHODOLOGY:

• Individuals with prediabetes not only are at an elevated risk for diabetes but also face an increased risk for incident gout. Many previous reports have demonstrated the efficacy of antidiabetic medications in reducing the risk for gout in adults with diabetes.
• This study assessed the gout-lowering properties of metformin in 25,064 individuals with prediabetes (age ≥ 18 years; A1c levels, 5.7%-6.4%) who had never reported A1c levels > 6.4%.
• Patients who were initiated on metformin within 18 months after the diagnosis of prediabetes (n = 1154) were propensity score–matched with those who did not initiate metformin or other antidiabetic medications in this period (n = 13,877) and were followed for a median of 3.9 years for the primary outcome of incident gout.

TAKEAWAY:

• Initiation vs no initiation of metformin resulted in 2.4 fewer cases of gout per 1000 person-years and a 32% reduced relative risk for incident gout (hazard ratio, 0.68; 95% CI, 0.48-0.96).
• The results were consistent across different subgroups stratified on the basis of sex, age (≤ 60 vs > 60 years), estimated glomerular filtration rate (≥ 90 vs < 90 mL/min/1.73 m²), and baseline diuretic use.
• Metformin initiation was not associated with significant changes in serum urate or C-reactive protein levels.
• Metformin use was associated with a reduction in A1c levels and body mass index.

IN PRACTICE:

The authors suggested that “metformin may be important in lowering gout risk in individuals with prediabetes.”

SOURCE:

Javier Marrugo, MD, Department of Medicine, Brigham and Women’s Hospital, Boston, led this study, which was published online in Annals of the Rheumatic Diseases.

LIMITATIONS:

Although gout is more commonly observed in men, around 60% of the study population consisted of women. Owing to the observational nature of this study, exposure misclassifications might have occurred. Misclassification of the outcome is also possible due to the presence of two or more diagnostic codes for gout and/or the combination of urate-lowering therapies or colchicine with at least one diagnostic code.

DISCLOSURES:

This work was supported by the National Institutes of Health. Some authors declared serving as consultants or receiving salary support or consulting fees from various sources.

A version of this article first appeared on Medscape.com.

TOPLINE:

Metformin use lowers the risk for gout by 32% in individuals with prediabetes; however, the treatment doesn’t change serum urate or C-reactive protein levels.

METHODOLOGY:

• Individuals with prediabetes not only are at an elevated risk for diabetes but also face an increased risk for incident gout. Many previous reports have demonstrated the efficacy of antidiabetic medications in reducing the risk for gout in adults with diabetes.
• This study assessed the gout-lowering properties of metformin in 25,064 individuals with prediabetes (age ≥ 18 years; A1c levels, 5.7%-6.4%) who had never reported A1c levels > 6.4%.
• Patients who were initiated on metformin within 18 months after the diagnosis of prediabetes (n = 1154) were propensity score–matched with those who did not initiate metformin or other antidiabetic medications in this period (n = 13,877) and were followed for a median of 3.9 years for the primary outcome of incident gout.

TAKEAWAY:

• Initiation vs no initiation of metformin resulted in 2.4 fewer cases of gout per 1000 person-years and a 32% reduced relative risk for incident gout (hazard ratio, 0.68; 95% CI, 0.48-0.96).
• The results were consistent across different subgroups stratified on the basis of sex, age (≤ 60 vs > 60 years), estimated glomerular filtration rate (≥ 90 vs < 90 mL/min/1.73 m²), and baseline diuretic use.
• Metformin initiation was not associated with significant changes in serum urate or C-reactive protein levels.
• Metformin use was associated with a reduction in A1c levels and body mass index.

IN PRACTICE:

The authors suggested that “metformin may be important in lowering gout risk in individuals with prediabetes.”

SOURCE:

Javier Marrugo, MD, Department of Medicine, Brigham and Women’s Hospital, Boston, led this study, which was published online in Annals of the Rheumatic Diseases.

LIMITATIONS:

Although gout is more commonly observed in men, around 60% of the study population consisted of women. Owing to the observational nature of this study, exposure misclassifications might have occurred. Misclassification of the outcome is also possible due to the presence of two or more diagnostic codes for gout and/or the combination of urate-lowering therapies or colchicine with at least one diagnostic code.

DISCLOSURES:

This work was supported by the National Institutes of Health. Some authors declared serving as consultants or receiving salary support or consulting fees from various sources.

A version of this article first appeared on Medscape.com.

TOPLINE:

Metformin use lowers the risk for gout by 32% in individuals with prediabetes; however, the treatment doesn’t change serum urate or C-reactive protein levels.

METHODOLOGY:

• Individuals with prediabetes not only are at an elevated risk for diabetes but also face an increased risk for incident gout. Many previous reports have demonstrated the efficacy of antidiabetic medications in reducing the risk for gout in adults with diabetes.
• This study assessed the gout-lowering properties of metformin in 25,064 individuals with prediabetes (age ≥ 18 years; A1c levels, 5.7%-6.4%) who had never reported A1c levels > 6.4%.
• Patients who were initiated on metformin within 18 months after the diagnosis of prediabetes (n = 1154) were propensity score–matched with those who did not initiate metformin or other antidiabetic medications in this period (n = 13,877) and were followed for a median of 3.9 years for the primary outcome of incident gout.

TAKEAWAY:

• Initiation vs no initiation of metformin resulted in 2.4 fewer cases of gout per 1000 person-years and a 32% reduced relative risk for incident gout (hazard ratio, 0.68; 95% CI, 0.48-0.96).
• The results were consistent across different subgroups stratified on the basis of sex, age (≤ 60 vs > 60 years), estimated glomerular filtration rate (≥ 90 vs < 90 mL/min/1.73 m²), and baseline diuretic use.
• Metformin initiation was not associated with significant changes in serum urate or C-reactive protein levels.
• Metformin use was associated with a reduction in A1c levels and body mass index.

IN PRACTICE:

The authors suggested that “metformin may be important in lowering gout risk in individuals with prediabetes.”

SOURCE:

Javier Marrugo, MD, Department of Medicine, Brigham and Women’s Hospital, Boston, led this study, which was published online in Annals of the Rheumatic Diseases.

LIMITATIONS:

Although gout is more commonly observed in men, around 60% of the study population consisted of women. Owing to the observational nature of this study, exposure misclassifications might have occurred. Misclassification of the outcome is also possible due to the presence of two or more diagnostic codes for gout and/or the combination of urate-lowering therapies or colchicine with at least one diagnostic code.

DISCLOSURES:

This work was supported by the National Institutes of Health. Some authors declared serving as consultants or receiving salary support or consulting fees from various sources.

A version of this article first appeared on Medscape.com.

TOPLINE:

Patients with both type 2 diabetes (T2D) and obesity who have a lower diabetes severity, as characterized by the individualized metabolic surgery (IMS) scoring system, achieve better weight loss outcomes with semaglutide.

METHODOLOGY:

• Prior studies indicate that semaglutide leads to inferior weight loss outcomes in patients with obesity who have T2D vs those without T2D; however, no study has assessed semaglutide’s weight loss effects as a function of T2D severity.
• The IMS score, which includes four parameters (A1c, < 7%; insulin use; number of T2D medications; and T2D duration), is a validated tool that can categorize T2D severity as mild (0-24.9 points), moderate (25-94.9 points), or severe (95-180 points).
• This retrospective cohort study of patients with obesity and T2D taking ≥ 1 mg of semaglutide investigated weight loss outcomes over 12 months based on IMS scores at baseline as well as changes in glycemic parameters.
• The primary endpoint was weight loss outcomes based on four IMS score quartiles (quartile 1, 12-78 points; quartile 2, 79-107 points; quartile 3, 108-129 points; and quartile 4, 130-172 points) at 12 months after starting semaglutide.

TAKEAWAY:

• Investigators included 297 patients (42% women; mean age, 61.5 years).
• At 12 months, the weight loss outcomes decreased in a stepwise manner as the IMS score quartiles increased from 1 to 4 (total body weight loss %; quartile 1, 8.8; quartile 2, 6.9; quartile 3, 5.7; and quartile 4, 5.0).
• Similarly, patients in the mild to moderate IMS category achieved significantly superior weight loss outcomes than those in the severe category (−8.3% vs −5.5%; P = .006) at 12 months.
• All four individual IMS parameters (ie, being on insulin, having a higher baseline level of A1c, having a longer duration of T2D, and using a greater number of diabetes medications) were independently associated with significantly inferior weight loss outcomes.
• Glycemic parameters, such as fasting blood glucose and A1c levels, did not improve regardless of the IMS severity at baseline.

IN PRACTICE:

“Our findings could help clinicians set informed expectations for weight loss outcomes in patients with severe T2D taking semaglutide; however, it is likely that the cardiometabolic benefits associated with semaglutide treatment in this population far exceed the effect on weight loss,” the authors commented.

SOURCE:

Wissam Ghusn, MD, from the Department of Medicine, Mayo Clinic, Rochester, Minnesota, led this study, which was published online in eClinicalMedicine.

LIMITATIONS:

Due to the retrospective nature of this study, the authors had limited ability to abstract data on all IMS parameters. The presence of predominantly White and male patients in this cohort limited the generalizability of this study’s findings to other external populations. The number of patients in the mild IMS category was extremely low.

DISCLOSURES:

This study did not receive any specific grants, but the involved research staff received payments from the Mayo Clinic. One of the authors declared serving as a consultant, having contracts, and holding equity in various companies.

A version of this article appeared on Medscape.com.

TOPLINE:

Patients with both type 2 diabetes (T2D) and obesity who have a lower diabetes severity, as characterized by the individualized metabolic surgery (IMS) scoring system, achieve better weight loss outcomes with semaglutide.

METHODOLOGY:

• Prior studies indicate that semaglutide leads to inferior weight loss outcomes in patients with obesity who have T2D vs those without T2D; however, no study has assessed semaglutide’s weight loss effects as a function of T2D severity.
• The IMS score, which includes four parameters (A1c, < 7%; insulin use; number of T2D medications; and T2D duration), is a validated tool that can categorize T2D severity as mild (0-24.9 points), moderate (25-94.9 points), or severe (95-180 points).
• This retrospective cohort study of patients with obesity and T2D taking ≥ 1 mg of semaglutide investigated weight loss outcomes over 12 months based on IMS scores at baseline as well as changes in glycemic parameters.
• The primary endpoint was weight loss outcomes based on four IMS score quartiles (quartile 1, 12-78 points; quartile 2, 79-107 points; quartile 3, 108-129 points; and quartile 4, 130-172 points) at 12 months after starting semaglutide.

TAKEAWAY:

• Investigators included 297 patients (42% women; mean age, 61.5 years).
• At 12 months, the weight loss outcomes decreased in a stepwise manner as the IMS score quartiles increased from 1 to 4 (total body weight loss %; quartile 1, 8.8; quartile 2, 6.9; quartile 3, 5.7; and quartile 4, 5.0).
• Similarly, patients in the mild to moderate IMS category achieved significantly superior weight loss outcomes than those in the severe category (−8.3% vs −5.5%; P = .006) at 12 months.
• All four individual IMS parameters (ie, being on insulin, having a higher baseline level of A1c, having a longer duration of T2D, and using a greater number of diabetes medications) were independently associated with significantly inferior weight loss outcomes.
• Glycemic parameters, such as fasting blood glucose and A1c levels, did not improve regardless of the IMS severity at baseline.

IN PRACTICE:

“Our findings could help clinicians set informed expectations for weight loss outcomes in patients with severe T2D taking semaglutide; however, it is likely that the cardiometabolic benefits associated with semaglutide treatment in this population far exceed the effect on weight loss,” the authors commented.

SOURCE:

Wissam Ghusn, MD, from the Department of Medicine, Mayo Clinic, Rochester, Minnesota, led this study, which was published online in eClinicalMedicine.

LIMITATIONS:

Due to the retrospective nature of this study, the authors had limited ability to abstract data on all IMS parameters. The presence of predominantly White and male patients in this cohort limited the generalizability of this study’s findings to other external populations. The number of patients in the mild IMS category was extremely low.

DISCLOSURES:

This study did not receive any specific grants, but the involved research staff received payments from the Mayo Clinic. One of the authors declared serving as a consultant, having contracts, and holding equity in various companies.

A version of this article appeared on Medscape.com.

TOPLINE:

Patients with both type 2 diabetes (T2D) and obesity who have a lower diabetes severity, as characterized by the individualized metabolic surgery (IMS) scoring system, achieve better weight loss outcomes with semaglutide.

METHODOLOGY:

• Prior studies indicate that semaglutide leads to inferior weight loss outcomes in patients with obesity who have T2D vs those without T2D; however, no study has assessed semaglutide’s weight loss effects as a function of T2D severity.
• The IMS score, which includes four parameters (A1c, < 7%; insulin use; number of T2D medications; and T2D duration), is a validated tool that can categorize T2D severity as mild (0-24.9 points), moderate (25-94.9 points), or severe (95-180 points).
• This retrospective cohort study of patients with obesity and T2D taking ≥ 1 mg of semaglutide investigated weight loss outcomes over 12 months based on IMS scores at baseline as well as changes in glycemic parameters.
• The primary endpoint was weight loss outcomes based on four IMS score quartiles (quartile 1, 12-78 points; quartile 2, 79-107 points; quartile 3, 108-129 points; and quartile 4, 130-172 points) at 12 months after starting semaglutide.

TAKEAWAY:

• Investigators included 297 patients (42% women; mean age, 61.5 years).
• At 12 months, the weight loss outcomes decreased in a stepwise manner as the IMS score quartiles increased from 1 to 4 (total body weight loss %; quartile 1, 8.8; quartile 2, 6.9; quartile 3, 5.7; and quartile 4, 5.0).
• Similarly, patients in the mild to moderate IMS category achieved significantly superior weight loss outcomes than those in the severe category (−8.3% vs −5.5%; P = .006) at 12 months.
• All four individual IMS parameters (ie, being on insulin, having a higher baseline level of A1c, having a longer duration of T2D, and using a greater number of diabetes medications) were independently associated with significantly inferior weight loss outcomes.
• Glycemic parameters, such as fasting blood glucose and A1c levels, did not improve regardless of the IMS severity at baseline.

IN PRACTICE:

“Our findings could help clinicians set informed expectations for weight loss outcomes in patients with severe T2D taking semaglutide; however, it is likely that the cardiometabolic benefits associated with semaglutide treatment in this population far exceed the effect on weight loss,” the authors commented.

SOURCE:

Wissam Ghusn, MD, from the Department of Medicine, Mayo Clinic, Rochester, Minnesota, led this study, which was published online in eClinicalMedicine.

LIMITATIONS:

Due to the retrospective nature of this study, the authors had limited ability to abstract data on all IMS parameters. The presence of predominantly White and male patients in this cohort limited the generalizability of this study’s findings to other external populations. The number of patients in the mild IMS category was extremely low.

DISCLOSURES:

This study did not receive any specific grants, but the involved research staff received payments from the Mayo Clinic. One of the authors declared serving as a consultant, having contracts, and holding equity in various companies.

A version of this article appeared on Medscape.com.

TOPLINE:

The adenoma missed rate (AMR), including lesions > 5 mm, was lower in patients whose precolonoscopy bowel preparation was deemed suitable using an artificial intelligence (AI)–guided assessment.

METHODOLOGY:

• Individuals with inappropriate bowel preparation before a colonoscopy face a higher lesion miss rate and may need to repeat the procedure.
• This prospective single-center study analyzed the screening colonoscopies of 393 individuals (mean age, 55 years; 50% men) using assessments made by endoscopists and AI.
• The AI-based method was the e-Boston Bowel Preparation Scale (e-BBPS), in which a score of 3 is the threshold to guarantee an adenoma detection rate of > 25%. Patients with an e-BBPS score of ≤ 3 or > 3 were considered by the AI as being qualified or unqualified, respectively.
• If the bowel preparation was considered adequate by the endoscopists and qualified by AI, individuals immediately underwent a repeat colonoscopy to assess for any missed lesions; otherwise, they underwent bowel recleansing before a repeat colonoscopy.
• The primary outcome was a > 5-mm AMR.

TAKEAWAY:

• The > 5-mm AMR was higher in individuals whose bowel preparation was deemed unqualified vs qualified by AI (35.71% vs 13.19%), particularly in the cecum (50.00% vs 25.00%), ascending colon (25.00% vs 9.09%), transverse colon (58.82% vs 14.71%), and descending colon (40.00% vs 21.43%).
• Similarly, any AMR (50.89% vs 20.79%), > 5-mm polyp miss rate (35.82% vs 19.48%), and any polyp miss rate (43.05% vs 25.51%) were higher in the unqualified AI vs qualified AI individuals.
• The rate of detection of adenomas > 5 mm (2.88% vs 11.25%) or any adenoma (15.97% vs 46.25%) was lower among the qualified AI vs unqualified AI individuals during the repeat colonoscopy.
• The e-BBPS also showed a high pairwise agreement with the analysis of expert endoscopists and moderate pairwise agreement with that of general endoscopists.

IN PRACTICE:

“The use of AI in bowel preparation assessment can relieve endoscopists’ workload, enabling them to concentrate more on detecting lesions during colonoscopy without being distracted by preparation evaluation, thus enhancing both efficiency and overall medical quality,” the authors wrote.

SOURCE:

The study, led by Liwen Yao, PhD, Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, China, was published online in Gastrointestinal Endoscopy.

LIMITATIONS:

Limitations included the study’s lack of external validity, including Western populations. Different bowel preparation regimens were not compared; therefore, conclusions about their efficacy cannot be deduced. The use of AI in the assessment of bowel preparation may lead to ethical issues, such as increased colonoscopy costs due to the technology and whether patients are fully informed.

DISCLOSURES:

This study was funded by the Science and Technology Achievement Transformation Platform Construction Project of Ministry of Education and Public Health Research Project of Futian District, Shenzhen. The authors declared no conflicts of interest.

A version of this article first appeared on Medscape.com.

TOPLINE:

The adenoma missed rate (AMR), including lesions > 5 mm, was lower in patients whose precolonoscopy bowel preparation was deemed suitable using an artificial intelligence (AI)–guided assessment.

METHODOLOGY:

• Individuals with inappropriate bowel preparation before a colonoscopy face a higher lesion miss rate and may need to repeat the procedure.
• This prospective single-center study analyzed the screening colonoscopies of 393 individuals (mean age, 55 years; 50% men) using assessments made by endoscopists and AI.
• The AI-based method was the e-Boston Bowel Preparation Scale (e-BBPS), in which a score of 3 is the threshold to guarantee an adenoma detection rate of > 25%. Patients with an e-BBPS score of ≤ 3 or > 3 were considered by the AI as being qualified or unqualified, respectively.
• If the bowel preparation was considered adequate by the endoscopists and qualified by AI, individuals immediately underwent a repeat colonoscopy to assess for any missed lesions; otherwise, they underwent bowel recleansing before a repeat colonoscopy.
• The primary outcome was a > 5-mm AMR.

TAKEAWAY:

• The > 5-mm AMR was higher in individuals whose bowel preparation was deemed unqualified vs qualified by AI (35.71% vs 13.19%), particularly in the cecum (50.00% vs 25.00%), ascending colon (25.00% vs 9.09%), transverse colon (58.82% vs 14.71%), and descending colon (40.00% vs 21.43%).
• Similarly, any AMR (50.89% vs 20.79%), > 5-mm polyp miss rate (35.82% vs 19.48%), and any polyp miss rate (43.05% vs 25.51%) were higher in the unqualified AI vs qualified AI individuals.
• The rate of detection of adenomas > 5 mm (2.88% vs 11.25%) or any adenoma (15.97% vs 46.25%) was lower among the qualified AI vs unqualified AI individuals during the repeat colonoscopy.
• The e-BBPS also showed a high pairwise agreement with the analysis of expert endoscopists and moderate pairwise agreement with that of general endoscopists.

IN PRACTICE:

“The use of AI in bowel preparation assessment can relieve endoscopists’ workload, enabling them to concentrate more on detecting lesions during colonoscopy without being distracted by preparation evaluation, thus enhancing both efficiency and overall medical quality,” the authors wrote.

SOURCE:

The study, led by Liwen Yao, PhD, Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, China, was published online in Gastrointestinal Endoscopy.

LIMITATIONS:

Limitations included the study’s lack of external validity, including Western populations. Different bowel preparation regimens were not compared; therefore, conclusions about their efficacy cannot be deduced. The use of AI in the assessment of bowel preparation may lead to ethical issues, such as increased colonoscopy costs due to the technology and whether patients are fully informed.

DISCLOSURES:

This study was funded by the Science and Technology Achievement Transformation Platform Construction Project of Ministry of Education and Public Health Research Project of Futian District, Shenzhen. The authors declared no conflicts of interest.

A version of this article first appeared on Medscape.com.

TOPLINE:

The adenoma missed rate (AMR), including lesions > 5 mm, was lower in patients whose precolonoscopy bowel preparation was deemed suitable using an artificial intelligence (AI)–guided assessment.

METHODOLOGY:

• Individuals with inappropriate bowel preparation before a colonoscopy face a higher lesion miss rate and may need to repeat the procedure.
• This prospective single-center study analyzed the screening colonoscopies of 393 individuals (mean age, 55 years; 50% men) using assessments made by endoscopists and AI.
• The AI-based method was the e-Boston Bowel Preparation Scale (e-BBPS), in which a score of 3 is the threshold to guarantee an adenoma detection rate of > 25%. Patients with an e-BBPS score of ≤ 3 or > 3 were considered by the AI as being qualified or unqualified, respectively.
• If the bowel preparation was considered adequate by the endoscopists and qualified by AI, individuals immediately underwent a repeat colonoscopy to assess for any missed lesions; otherwise, they underwent bowel recleansing before a repeat colonoscopy.
• The primary outcome was a > 5-mm AMR.

TAKEAWAY:

• The > 5-mm AMR was higher in individuals whose bowel preparation was deemed unqualified vs qualified by AI (35.71% vs 13.19%), particularly in the cecum (50.00% vs 25.00%), ascending colon (25.00% vs 9.09%), transverse colon (58.82% vs 14.71%), and descending colon (40.00% vs 21.43%).
• Similarly, any AMR (50.89% vs 20.79%), > 5-mm polyp miss rate (35.82% vs 19.48%), and any polyp miss rate (43.05% vs 25.51%) were higher in the unqualified AI vs qualified AI individuals.
• The rate of detection of adenomas > 5 mm (2.88% vs 11.25%) or any adenoma (15.97% vs 46.25%) was lower among the qualified AI vs unqualified AI individuals during the repeat colonoscopy.
• The e-BBPS also showed a high pairwise agreement with the analysis of expert endoscopists and moderate pairwise agreement with that of general endoscopists.

IN PRACTICE:

“The use of AI in bowel preparation assessment can relieve endoscopists’ workload, enabling them to concentrate more on detecting lesions during colonoscopy without being distracted by preparation evaluation, thus enhancing both efficiency and overall medical quality,” the authors wrote.

SOURCE:

The study, led by Liwen Yao, PhD, Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, China, was published online in Gastrointestinal Endoscopy.

LIMITATIONS:

Limitations included the study’s lack of external validity, including Western populations. Different bowel preparation regimens were not compared; therefore, conclusions about their efficacy cannot be deduced. The use of AI in the assessment of bowel preparation may lead to ethical issues, such as increased colonoscopy costs due to the technology and whether patients are fully informed.

DISCLOSURES:

This study was funded by the Science and Technology Achievement Transformation Platform Construction Project of Ministry of Education and Public Health Research Project of Futian District, Shenzhen. The authors declared no conflicts of interest.

A version of this article first appeared on Medscape.com.

TOPLINE:

Various food additive emulsifiers, including total carrageenans, carrageenan gum, tripotassium phosphate, sodium citrate, and guar gum, can increase the risk for type 2 diabetes (T2D), showed a recent study.

METHODOLOGY:

• Food emulsifiers, which are extensively used to enhance the texture and improve the shelf life of various ultraprocessed food items, have been shown to increase the risk for cardiovascular disease and cancer.
• In this study, the dietary intake data of 104,139 adults (79.2% women; mean age, 42.7 years) enrolled in the French NutriNet-Santé prospective cohort study from May 2009 to April 2023 were assessed for 24 hours on 3 nonconsecutive days at inclusion and every 6 months thereafter to determine the risk for T2D.
• The dietary records of participants, which were linked to food composition databases, were used to quantify the food additive intake.
• T2D cases were identified using a multisource approach encompassing self-reports, health questionnaires, national health insurance system databases, and/or mortality registries.

TAKEAWAY:

• During a mean follow-up period of 6.8 years, 1056 incident cases of T2D were reported.
• Almost all (99.7%) participants were exposed to at least one food additive emulsifier, with the main contributors being ultraprocessed fruits and vegetables (18.5%), cakes and biscuits (14.7%), and dairy products (10.0%).
• The intake of the following emulsifiers increased the risk for T2D:
• Total carrageenans and carrageenan gum (3% increased risk per increment of 100 mg/d; P < .001)
• Tripotassium phosphate (15% increased risk per increment of 500 mg/d; P = .023)
• Acetyl tartaric acid esters of monoglycerides and diglycerides of fatty acids (4% increased risk per increment of 100 mg/d; P = .042)
• Sodium citrate (4% increased risk per increment of 500 mg/d; P = .008)
• Guar gum (11% increased risk per increment of 500 mg/d; P < .0001)
• Gum arabic (3% increased risk per increment of 1000 mg/d; P = .013)
• Xanthan gum (8% increased risk per increment of 500 mg/d; P = .013)

IN PRACTICE:

In an accompanying commentary, experts postulated that “findings from this and other studies could prompt regulatory agencies and policymakers to reconsider the rules governing the use of emulsifiers and other additives by the food industry such as setting limits and requiring better disclosure of food additive contents to help consumers make more informed choices.”

SOURCE:

Clara Salame, PhD, Université Sorbonne Paris Nord and Université Paris Cité, INSERM, INRAE, CNAM, Center of Research in Epidemiology and Statistics, Nutritional Epidemiology Research Team, Paris, France, led this study, which was published online in The Lancet Diabetes & Endocrinology.

LIMITATIONS:

The observational nature of this study is not sufficient to establish causality relationships. There may have been measurement errors in emulsifier exposure, particularly in products exempted from labeling requirements. This cohort’s demographics, which included a higher percentage of women and a health-conscious population, may affect the generalizability of the study’s findings.

DISCLOSURES:

This study received funding from the European Research Council, and the NutriNet-Santé study was supported by many public institutions such as the Ministère de la Santé, Santé publique France, Université Sorbonne Paris Nord, and others. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Various food additive emulsifiers, including total carrageenans, carrageenan gum, tripotassium phosphate, sodium citrate, and guar gum, can increase the risk for type 2 diabetes (T2D), showed a recent study.

METHODOLOGY:

• Food emulsifiers, which are extensively used to enhance the texture and improve the shelf life of various ultraprocessed food items, have been shown to increase the risk for cardiovascular disease and cancer.
• In this study, the dietary intake data of 104,139 adults (79.2% women; mean age, 42.7 years) enrolled in the French NutriNet-Santé prospective cohort study from May 2009 to April 2023 were assessed for 24 hours on 3 nonconsecutive days at inclusion and every 6 months thereafter to determine the risk for T2D.
• The dietary records of participants, which were linked to food composition databases, were used to quantify the food additive intake.
• T2D cases were identified using a multisource approach encompassing self-reports, health questionnaires, national health insurance system databases, and/or mortality registries.

TAKEAWAY:

• During a mean follow-up period of 6.8 years, 1056 incident cases of T2D were reported.
• Almost all (99.7%) participants were exposed to at least one food additive emulsifier, with the main contributors being ultraprocessed fruits and vegetables (18.5%), cakes and biscuits (14.7%), and dairy products (10.0%).
• The intake of the following emulsifiers increased the risk for T2D:
• Total carrageenans and carrageenan gum (3% increased risk per increment of 100 mg/d; P < .001)
• Tripotassium phosphate (15% increased risk per increment of 500 mg/d; P = .023)
• Acetyl tartaric acid esters of monoglycerides and diglycerides of fatty acids (4% increased risk per increment of 100 mg/d; P = .042)
• Sodium citrate (4% increased risk per increment of 500 mg/d; P = .008)
• Guar gum (11% increased risk per increment of 500 mg/d; P < .0001)
• Gum arabic (3% increased risk per increment of 1000 mg/d; P = .013)
• Xanthan gum (8% increased risk per increment of 500 mg/d; P = .013)

IN PRACTICE:

In an accompanying commentary, experts postulated that “findings from this and other studies could prompt regulatory agencies and policymakers to reconsider the rules governing the use of emulsifiers and other additives by the food industry such as setting limits and requiring better disclosure of food additive contents to help consumers make more informed choices.”

SOURCE:

Clara Salame, PhD, Université Sorbonne Paris Nord and Université Paris Cité, INSERM, INRAE, CNAM, Center of Research in Epidemiology and Statistics, Nutritional Epidemiology Research Team, Paris, France, led this study, which was published online in The Lancet Diabetes & Endocrinology.

LIMITATIONS:

The observational nature of this study is not sufficient to establish causality relationships. There may have been measurement errors in emulsifier exposure, particularly in products exempted from labeling requirements. This cohort’s demographics, which included a higher percentage of women and a health-conscious population, may affect the generalizability of the study’s findings.

DISCLOSURES:

This study received funding from the European Research Council, and the NutriNet-Santé study was supported by many public institutions such as the Ministère de la Santé, Santé publique France, Université Sorbonne Paris Nord, and others. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Various food additive emulsifiers, including total carrageenans, carrageenan gum, tripotassium phosphate, sodium citrate, and guar gum, can increase the risk for type 2 diabetes (T2D), showed a recent study.

METHODOLOGY:

• Food emulsifiers, which are extensively used to enhance the texture and improve the shelf life of various ultraprocessed food items, have been shown to increase the risk for cardiovascular disease and cancer.
• In this study, the dietary intake data of 104,139 adults (79.2% women; mean age, 42.7 years) enrolled in the French NutriNet-Santé prospective cohort study from May 2009 to April 2023 were assessed for 24 hours on 3 nonconsecutive days at inclusion and every 6 months thereafter to determine the risk for T2D.
• The dietary records of participants, which were linked to food composition databases, were used to quantify the food additive intake.
• T2D cases were identified using a multisource approach encompassing self-reports, health questionnaires, national health insurance system databases, and/or mortality registries.

TAKEAWAY:

• During a mean follow-up period of 6.8 years, 1056 incident cases of T2D were reported.
• Almost all (99.7%) participants were exposed to at least one food additive emulsifier, with the main contributors being ultraprocessed fruits and vegetables (18.5%), cakes and biscuits (14.7%), and dairy products (10.0%).
• The intake of the following emulsifiers increased the risk for T2D:
• Total carrageenans and carrageenan gum (3% increased risk per increment of 100 mg/d; P < .001)
• Tripotassium phosphate (15% increased risk per increment of 500 mg/d; P = .023)
• Acetyl tartaric acid esters of monoglycerides and diglycerides of fatty acids (4% increased risk per increment of 100 mg/d; P = .042)
• Sodium citrate (4% increased risk per increment of 500 mg/d; P = .008)
• Guar gum (11% increased risk per increment of 500 mg/d; P < .0001)
• Gum arabic (3% increased risk per increment of 1000 mg/d; P = .013)
• Xanthan gum (8% increased risk per increment of 500 mg/d; P = .013)

IN PRACTICE:

In an accompanying commentary, experts postulated that “findings from this and other studies could prompt regulatory agencies and policymakers to reconsider the rules governing the use of emulsifiers and other additives by the food industry such as setting limits and requiring better disclosure of food additive contents to help consumers make more informed choices.”

SOURCE:

Clara Salame, PhD, Université Sorbonne Paris Nord and Université Paris Cité, INSERM, INRAE, CNAM, Center of Research in Epidemiology and Statistics, Nutritional Epidemiology Research Team, Paris, France, led this study, which was published online in The Lancet Diabetes & Endocrinology.

LIMITATIONS:

The observational nature of this study is not sufficient to establish causality relationships. There may have been measurement errors in emulsifier exposure, particularly in products exempted from labeling requirements. This cohort’s demographics, which included a higher percentage of women and a health-conscious population, may affect the generalizability of the study’s findings.

DISCLOSURES:

This study received funding from the European Research Council, and the NutriNet-Santé study was supported by many public institutions such as the Ministère de la Santé, Santé publique France, Université Sorbonne Paris Nord, and others. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Treatment with biologic disease-modifying antirheumatic drugs (bDMARDs), particularly tocilizumab, can suppress inflammation and preserve renal function in a majority of patients with chronic inflammatory disorders who develop serum amyloid alpha (SAA) amyloidosis.

METHODOLOGY:

• AA amyloidosis, characterized by the misfolding of the SAA protein, is observed in patients with inflammatory diseases and can lead to progressive organ damage, including chronic kidney disease, malabsorption with cachexia, and cardiac failure.
• This monocentric, retrospective analysis assessed the effect of bDMARD therapy on inflammatory biomarker levels and renal outcomes in 83 patients with AA amyloidosis who were followed for a mean period of 4.82 years.
• The patients were stratified into three major subgroups depending on the cause of AA amyloidosis:
• Chronic inflammatory diseases (cid + AA; n = 34) such as rheumatoid arthritis, Crohn’s disease, and chronic infections
• Autoinflammatory syndromes (auto + AA; n = 24) such as familial Mediterranean fever (FMF) and cryopyrin-associated periodic syndrome (CAPS)
• Idiopathic AA (idio + AA; n = 25), wherein the primary disease could not be identified
• Tocilizumab was the most commonly used bDMARD in patients with cid + AA and idio + AA amyloidosis, and interleukin-1 inhibitors were prescribed to patients with auto + AA amyloidosis because tocilizumab has not been approved yet for FMF or CAPS treatment.
• All patients with AA amyloidosis had renal involvement, as confirmed by kidney biopsy.

TAKEAWAY:

• After bDMARD therapy, C-reactive protein levels reduced significantly from baseline to the last-documented visit in all subgroups, while SAA levels declined in the subgroups cid + AA and idio + AA and proteinuria dropped in the subgroups auto + AA and idio + AA.
• bDMARDs prevented progression to end-stage renal disease (ESRD) in 75% of the patients in the overall cohort, with progression to ESRD being prevented in 60% of patients with cid + AA, 88% of patients with auto + AA, and 81% of patients with idio + AA.
• Tocilizumab was more effective than other bDMARDs in preventing renal progression to ESRD (P = .0006), with a similar pattern observed for the subgroups cid + AA (P = .0126) and idio + AA (P = .0259).
• None of the patients receiving tocilizumab died during the nearly 5-year follow-up period.

IN PRACTICE:

“The data suggest preferential use of IL [interleukin]-1 inhibitors and tocilizumab for clinical use in the treatment of AA amyloidosis depending on the respective underlying diseases,” the authors wrote.

SOURCE:

This study, led by Peter Kvacskay, MD, of Heidelberg University Hospital, Heidelberg, Germany, was published online on April 23 in Annals of the Rheumatic Diseases.

LIMITATIONS:

Authors acknowledged the retrospective nature of the analysis and missing data of single patients during the long-term follow-up as major limitations. Furthermore, the cid + AA subgroup was heterogeneous in terms of the pathophysiology of their underlying primary disease.

DISCLOSURES:

This study did not report any source of funding. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Treatment with biologic disease-modifying antirheumatic drugs (bDMARDs), particularly tocilizumab, can suppress inflammation and preserve renal function in a majority of patients with chronic inflammatory disorders who develop serum amyloid alpha (SAA) amyloidosis.

METHODOLOGY:

• AA amyloidosis, characterized by the misfolding of the SAA protein, is observed in patients with inflammatory diseases and can lead to progressive organ damage, including chronic kidney disease, malabsorption with cachexia, and cardiac failure.
• This monocentric, retrospective analysis assessed the effect of bDMARD therapy on inflammatory biomarker levels and renal outcomes in 83 patients with AA amyloidosis who were followed for a mean period of 4.82 years.
• The patients were stratified into three major subgroups depending on the cause of AA amyloidosis:
• Chronic inflammatory diseases (cid + AA; n = 34) such as rheumatoid arthritis, Crohn’s disease, and chronic infections
• Autoinflammatory syndromes (auto + AA; n = 24) such as familial Mediterranean fever (FMF) and cryopyrin-associated periodic syndrome (CAPS)
• Idiopathic AA (idio + AA; n = 25), wherein the primary disease could not be identified
• Tocilizumab was the most commonly used bDMARD in patients with cid + AA and idio + AA amyloidosis, and interleukin-1 inhibitors were prescribed to patients with auto + AA amyloidosis because tocilizumab has not been approved yet for FMF or CAPS treatment.
• All patients with AA amyloidosis had renal involvement, as confirmed by kidney biopsy.

TAKEAWAY:

• After bDMARD therapy, C-reactive protein levels reduced significantly from baseline to the last-documented visit in all subgroups, while SAA levels declined in the subgroups cid + AA and idio + AA and proteinuria dropped in the subgroups auto + AA and idio + AA.
• bDMARDs prevented progression to end-stage renal disease (ESRD) in 75% of the patients in the overall cohort, with progression to ESRD being prevented in 60% of patients with cid + AA, 88% of patients with auto + AA, and 81% of patients with idio + AA.
• Tocilizumab was more effective than other bDMARDs in preventing renal progression to ESRD (P = .0006), with a similar pattern observed for the subgroups cid + AA (P = .0126) and idio + AA (P = .0259).
• None of the patients receiving tocilizumab died during the nearly 5-year follow-up period.

IN PRACTICE:

“The data suggest preferential use of IL [interleukin]-1 inhibitors and tocilizumab for clinical use in the treatment of AA amyloidosis depending on the respective underlying diseases,” the authors wrote.

SOURCE:

This study, led by Peter Kvacskay, MD, of Heidelberg University Hospital, Heidelberg, Germany, was published online on April 23 in Annals of the Rheumatic Diseases.

LIMITATIONS:

Authors acknowledged the retrospective nature of the analysis and missing data of single patients during the long-term follow-up as major limitations. Furthermore, the cid + AA subgroup was heterogeneous in terms of the pathophysiology of their underlying primary disease.

DISCLOSURES:

This study did not report any source of funding. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Treatment with biologic disease-modifying antirheumatic drugs (bDMARDs), particularly tocilizumab, can suppress inflammation and preserve renal function in a majority of patients with chronic inflammatory disorders who develop serum amyloid alpha (SAA) amyloidosis.

METHODOLOGY:

• AA amyloidosis, characterized by the misfolding of the SAA protein, is observed in patients with inflammatory diseases and can lead to progressive organ damage, including chronic kidney disease, malabsorption with cachexia, and cardiac failure.
• This monocentric, retrospective analysis assessed the effect of bDMARD therapy on inflammatory biomarker levels and renal outcomes in 83 patients with AA amyloidosis who were followed for a mean period of 4.82 years.
• The patients were stratified into three major subgroups depending on the cause of AA amyloidosis:
• Chronic inflammatory diseases (cid + AA; n = 34) such as rheumatoid arthritis, Crohn’s disease, and chronic infections
• Autoinflammatory syndromes (auto + AA; n = 24) such as familial Mediterranean fever (FMF) and cryopyrin-associated periodic syndrome (CAPS)
• Idiopathic AA (idio + AA; n = 25), wherein the primary disease could not be identified
• Tocilizumab was the most commonly used bDMARD in patients with cid + AA and idio + AA amyloidosis, and interleukin-1 inhibitors were prescribed to patients with auto + AA amyloidosis because tocilizumab has not been approved yet for FMF or CAPS treatment.
• All patients with AA amyloidosis had renal involvement, as confirmed by kidney biopsy.

TAKEAWAY:

• After bDMARD therapy, C-reactive protein levels reduced significantly from baseline to the last-documented visit in all subgroups, while SAA levels declined in the subgroups cid + AA and idio + AA and proteinuria dropped in the subgroups auto + AA and idio + AA.
• bDMARDs prevented progression to end-stage renal disease (ESRD) in 75% of the patients in the overall cohort, with progression to ESRD being prevented in 60% of patients with cid + AA, 88% of patients with auto + AA, and 81% of patients with idio + AA.
• Tocilizumab was more effective than other bDMARDs in preventing renal progression to ESRD (P = .0006), with a similar pattern observed for the subgroups cid + AA (P = .0126) and idio + AA (P = .0259).
• None of the patients receiving tocilizumab died during the nearly 5-year follow-up period.

IN PRACTICE:

“The data suggest preferential use of IL [interleukin]-1 inhibitors and tocilizumab for clinical use in the treatment of AA amyloidosis depending on the respective underlying diseases,” the authors wrote.

SOURCE:

This study, led by Peter Kvacskay, MD, of Heidelberg University Hospital, Heidelberg, Germany, was published online on April 23 in Annals of the Rheumatic Diseases.

LIMITATIONS:

Authors acknowledged the retrospective nature of the analysis and missing data of single patients during the long-term follow-up as major limitations. Furthermore, the cid + AA subgroup was heterogeneous in terms of the pathophysiology of their underlying primary disease.

DISCLOSURES:

This study did not report any source of funding. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE: 

Two days a week of a medically supervised energy-restricted diet may lower blood glucose levels in adults with overweight or obesity and type 2 diabetes (T2D).

METHODOLOGY:

• Daily calorie restrictions and increased physical activity improve glycemic control and induce diabetes remission in patients with T2D, but these approaches are challenging to adhere to.
• Researchers tested whether 2 days a week (a 5:2 regimen) of either a very low-calorie formula diet or a “weekend warrior” physical activity pattern would be effective and more convenient.
• The three-arm IDEATE study enrolled 326 Asian participants with overweight or mild obesity (body mass index, 25.0-39.9) and T2D (diagnosed within prior 2 years; A1c, 7.0-8.9%; not on insulin) and randomly assigned them to receive a diet intervention, an exercise intervention, or routine lifestyle education (control group) for 12 weeks.
• The diet intervention group received an energy-restricted diet of 790 kcal/d on 2 days each week, and the exercise intervention group performed high-intensity interval training (4 minutes of aerobic activity, with a 10-minute total warm-up and cool-down) and resistance training twice a week (four exercises, two sets of eight to 12 repetitions).
• The primary outcome was the change in glycemic control between the diet or exercise intervention group and the control group after 12 weeks. Follow-up continued up to 1 year after intervention.

TAKEAWAY:

• Compared with the control group, patients in the diet intervention group achieved greater reductions in A1c after 12 weeks (difference, -0.34; P =.007), whereas A1c reductions in the exercise intervention group did not differ significantly from the control group.
• The likelihood of achieving diabetes remission was higher in the diet intervention vs the control group (adjusted odds ratio, 3.60; P = .008) but not in the exercise intervention group (P =.52).
• Body weight, body mass index, and high-density lipoprtein cholesterol levels were more effectively controlled in the diet intervention group only.
• However, participants in both the diet and exercise intervention groups showed reduced adiposity, liver fat content, and diastolic blood pressure compared with those in the control group.

IN PRACTICE:

“The diet intervention group experienced a greater energy deficit with a more pronounced metabolic benefit,” the authors wrote. “Our study suggests that a medically supervised 5:2 energy-restricted diet could serve as an alternative strategy for improving glycemic control.” 

SOURCE:

Mian Li, of the Department of Endocrine and Metabolic Diseases, Shanghai Institute of Endocrine and Metabolic Diseases, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China, led the study, which was published online in Diabetes Care.

LIMITATIONS:

Body composition was analyzed using bioelectrical impedance analysis, which is a less accurate technique than dual-energy x-ray absorptiometry. The study used finger-prick tests to monitor blood glucose levels, which could have underestimated both hyperglycemic and hypoglycemic episodes. No information was collected on whether the participants maintained the diet or exercise regimen during the postintervention follow-up period.

DISCLOSURES:

This study was supported by the National Key Research and Development Program of China, National Natural Science Foundation of China, Shanghai Rising Star Program grant, and other sources. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE: 

Two days a week of a medically supervised energy-restricted diet may lower blood glucose levels in adults with overweight or obesity and type 2 diabetes (T2D).

METHODOLOGY:

• Daily calorie restrictions and increased physical activity improve glycemic control and induce diabetes remission in patients with T2D, but these approaches are challenging to adhere to.
• Researchers tested whether 2 days a week (a 5:2 regimen) of either a very low-calorie formula diet or a “weekend warrior” physical activity pattern would be effective and more convenient.
• The three-arm IDEATE study enrolled 326 Asian participants with overweight or mild obesity (body mass index, 25.0-39.9) and T2D (diagnosed within prior 2 years; A1c, 7.0-8.9%; not on insulin) and randomly assigned them to receive a diet intervention, an exercise intervention, or routine lifestyle education (control group) for 12 weeks.
• The diet intervention group received an energy-restricted diet of 790 kcal/d on 2 days each week, and the exercise intervention group performed high-intensity interval training (4 minutes of aerobic activity, with a 10-minute total warm-up and cool-down) and resistance training twice a week (four exercises, two sets of eight to 12 repetitions).
• The primary outcome was the change in glycemic control between the diet or exercise intervention group and the control group after 12 weeks. Follow-up continued up to 1 year after intervention.

TAKEAWAY:

• Compared with the control group, patients in the diet intervention group achieved greater reductions in A1c after 12 weeks (difference, -0.34; P =.007), whereas A1c reductions in the exercise intervention group did not differ significantly from the control group.
• The likelihood of achieving diabetes remission was higher in the diet intervention vs the control group (adjusted odds ratio, 3.60; P = .008) but not in the exercise intervention group (P =.52).
• Body weight, body mass index, and high-density lipoprtein cholesterol levels were more effectively controlled in the diet intervention group only.
• However, participants in both the diet and exercise intervention groups showed reduced adiposity, liver fat content, and diastolic blood pressure compared with those in the control group.

IN PRACTICE:

“The diet intervention group experienced a greater energy deficit with a more pronounced metabolic benefit,” the authors wrote. “Our study suggests that a medically supervised 5:2 energy-restricted diet could serve as an alternative strategy for improving glycemic control.” 

SOURCE:

Mian Li, of the Department of Endocrine and Metabolic Diseases, Shanghai Institute of Endocrine and Metabolic Diseases, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China, led the study, which was published online in Diabetes Care.

LIMITATIONS:

Body composition was analyzed using bioelectrical impedance analysis, which is a less accurate technique than dual-energy x-ray absorptiometry. The study used finger-prick tests to monitor blood glucose levels, which could have underestimated both hyperglycemic and hypoglycemic episodes. No information was collected on whether the participants maintained the diet or exercise regimen during the postintervention follow-up period.

DISCLOSURES:

This study was supported by the National Key Research and Development Program of China, National Natural Science Foundation of China, Shanghai Rising Star Program grant, and other sources. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE: 

Two days a week of a medically supervised energy-restricted diet may lower blood glucose levels in adults with overweight or obesity and type 2 diabetes (T2D).

METHODOLOGY:

• Daily calorie restrictions and increased physical activity improve glycemic control and induce diabetes remission in patients with T2D, but these approaches are challenging to adhere to.
• Researchers tested whether 2 days a week (a 5:2 regimen) of either a very low-calorie formula diet or a “weekend warrior” physical activity pattern would be effective and more convenient.
• The three-arm IDEATE study enrolled 326 Asian participants with overweight or mild obesity (body mass index, 25.0-39.9) and T2D (diagnosed within prior 2 years; A1c, 7.0-8.9%; not on insulin) and randomly assigned them to receive a diet intervention, an exercise intervention, or routine lifestyle education (control group) for 12 weeks.
• The diet intervention group received an energy-restricted diet of 790 kcal/d on 2 days each week, and the exercise intervention group performed high-intensity interval training (4 minutes of aerobic activity, with a 10-minute total warm-up and cool-down) and resistance training twice a week (four exercises, two sets of eight to 12 repetitions).
• The primary outcome was the change in glycemic control between the diet or exercise intervention group and the control group after 12 weeks. Follow-up continued up to 1 year after intervention.

TAKEAWAY:

• Compared with the control group, patients in the diet intervention group achieved greater reductions in A1c after 12 weeks (difference, -0.34; P =.007), whereas A1c reductions in the exercise intervention group did not differ significantly from the control group.
• The likelihood of achieving diabetes remission was higher in the diet intervention vs the control group (adjusted odds ratio, 3.60; P = .008) but not in the exercise intervention group (P =.52).
• Body weight, body mass index, and high-density lipoprtein cholesterol levels were more effectively controlled in the diet intervention group only.
• However, participants in both the diet and exercise intervention groups showed reduced adiposity, liver fat content, and diastolic blood pressure compared with those in the control group.

IN PRACTICE:

“The diet intervention group experienced a greater energy deficit with a more pronounced metabolic benefit,” the authors wrote. “Our study suggests that a medically supervised 5:2 energy-restricted diet could serve as an alternative strategy for improving glycemic control.” 

SOURCE:

Mian Li, of the Department of Endocrine and Metabolic Diseases, Shanghai Institute of Endocrine and Metabolic Diseases, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China, led the study, which was published online in Diabetes Care.

LIMITATIONS:

Body composition was analyzed using bioelectrical impedance analysis, which is a less accurate technique than dual-energy x-ray absorptiometry. The study used finger-prick tests to monitor blood glucose levels, which could have underestimated both hyperglycemic and hypoglycemic episodes. No information was collected on whether the participants maintained the diet or exercise regimen during the postintervention follow-up period.

DISCLOSURES:

This study was supported by the National Key Research and Development Program of China, National Natural Science Foundation of China, Shanghai Rising Star Program grant, and other sources. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.