American Association of Clinical Endocrinologists (AACE): Annual Meeting and Clinical Congress

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Liraglutide tested as add-on therapy for type 1 diabetes

Results show potential for GLP-1 agonists
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Liraglutide tested as add-on therapy for type 1 diabetes

LAS VEGAS – In patients with type 1 diabetes, adding a 1.8-mg daily dose of liraglutide to insulin significantly reduced hemoglobin A1c, mean blood glucose, body weight, carbohydrate intake, and C-reactive protein, in a randomized study.

The 72-patient study also showed that adding liraglutide (Victoza) significantly improved quality of life and reduced systolic blood pressure in the groups that were receiving higher doses of the medicine.

Naseem Miller/Frontline Medical News
Dr. Nitesh Kuhadiya

"Our findings have significant implications for the future treatment of type 1 diabetes," said Dr. Nitesh Kuhadiya of the State University of New York at Buffalo, who presented the findings at the annual meeting of the American Association of Clinical Endocrinologists. "Long term studies are needed to establish the durability of the effects."

In previous small, nonrandomized studies of patients with type 1 diabetes, liraglutide improved glycemic control and led to weight loss (Eur. J. Endocrinol. 2011;165:77-84; Endocr. Pract. 2013;19:963-7). They then decided to conduct a randomized controlled trial, which is the first of its kind, said Dr. Kuhadiya, who compared type 1 diabetes to a "wild horse that’s extremely difficult to tame and kicks you 10 times a day."

For the study, researchers randomized 72 patients to four groups to receive 0.6, 1.2, or 1.8 mg of liraglutide or a placebo daily for 12 weeks. One patient dropped out of placebo group, as well as five from the 1.2-mg and three from the 1.8-mg group.

The groups’ baseline characteristics were similar. All patients had type 1 diabetes for at least 1 year, were on insulin therapy, and had no detectable C-peptide in plasma. The mean age was 44 years, mean body weight was 83 kg, mean body mass index was 29 kg/m2, mean HbA1c was 7.5, and mean interval since diabetes diagnosis was 20 years. Nearly all (96%) patients were white and 56% were women.

There was a significant drop of nearly 10 mg/dL in average glucose in the 1.2- and 1.8-mg groups. The HbA1c, also dropped in those two groups, although it was significant in only the 1.2-mg group, by about 0.8%. The drop was 0.4% in 1.8-mg group, 0.2% in the 0.6-mg group, and 0.3% in the placebo subjects.

There were also significant changes in the percent time spent in different glycemic thresholds for the 1.8-mg group. 

Patients on 1.2 mg and 1.8 mg of liraglutide spent about 3%-5% more time in the 70- to 160-mg/dL zone, respectively, although only those on 1.8 mg reached statistical significance. 

Again, the 1.2- and 1.8-mg groups spent less time in hyperglycemia, defined as 160-240 mg/dL, Dr. Kuhadiya said. No significant changes were observed in the other two groups. 

A similar trend was seen for severe hyperglycemia (250 mg/dL). 

There was, however, some additional hypoglycemia in the study in the range of 55 to 70 mg/dL, Dr. Kuhadiya reported. The 1.2- and 1.8-mg groups spent significantly more time (nearly 1%) in that range, but there was no incidence of hypoglycemia in the placebo and 0.6-mg groups. The results were similar for the less than 50 mg/dL range. However, there was no incidence of hypoglycemia requiring hospitalization or medical attention, Dr. Kuhadiya said. 

All three groups receiving liraglutide showed significant weight loss: nearly 5 kg in the 1.2- and 1.8-mg groups, and 3 kg in the 0.6-mg group, over a period of 12 weeks. 

The carbohydrate intake for the 1.2- and 1.8-mg groups also dropped significantly. 

Dr. Kuhadiya said that the findings also show that all changes are independent of each other. 

All groups showed a fall in C-reactive protein, which is a marker for cardiovascular risk, although only the 1.8-mg groups showed a statistical significance. "And this is important because most patients with type 1 diabetes have metabolic syndrome, and to be able to demonstrate all these changes and an additional fall in CRP means further protection from cardiovascular risk," Dr. Kuhadiya said.

The study was funded by Novo Nordisk. Dr. Kuhadiya had no relevant disclosures.

nmiller@frontlinemedcom.com

On Twitter @naseemmiller

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The drug works. It makes sense. This study proves it. I think there’s a lot of potential for use of GLP-1 [glucagonlike peptide–1] agonists as additional therapy to insulin in type 1 diabetes given their unique mode of action, and especially since today many patients are overweight. About 35% of type 1 diabetes patients, and maybe even more, are beginning to show insulin resistance because they’re overweight. Getting a drug on board that promotes weight loss as well as helps control blood sugar is very valuable.

The drug is already being prescribed to some extent on an off-label basis, but insurance companies don’t approve or reimburse for its use in type 1 diabetes.

Paul Jellinger, M.D., is professor of clinical medicine at the University of Miami and an endocrinologist in Hollywood, Fla. He is on the speakers bureaus for Novo Nordisk, Boehringer Ingelheim, Janssen, Bristol-Myers Squibb, and Amarin. He was not involved in the study.

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The drug works. It makes sense. This study proves it. I think there’s a lot of potential for use of GLP-1 [glucagonlike peptide–1] agonists as additional therapy to insulin in type 1 diabetes given their unique mode of action, and especially since today many patients are overweight. About 35% of type 1 diabetes patients, and maybe even more, are beginning to show insulin resistance because they’re overweight. Getting a drug on board that promotes weight loss as well as helps control blood sugar is very valuable.

The drug is already being prescribed to some extent on an off-label basis, but insurance companies don’t approve or reimburse for its use in type 1 diabetes.

Paul Jellinger, M.D., is professor of clinical medicine at the University of Miami and an endocrinologist in Hollywood, Fla. He is on the speakers bureaus for Novo Nordisk, Boehringer Ingelheim, Janssen, Bristol-Myers Squibb, and Amarin. He was not involved in the study.

Body

The drug works. It makes sense. This study proves it. I think there’s a lot of potential for use of GLP-1 [glucagonlike peptide–1] agonists as additional therapy to insulin in type 1 diabetes given their unique mode of action, and especially since today many patients are overweight. About 35% of type 1 diabetes patients, and maybe even more, are beginning to show insulin resistance because they’re overweight. Getting a drug on board that promotes weight loss as well as helps control blood sugar is very valuable.

The drug is already being prescribed to some extent on an off-label basis, but insurance companies don’t approve or reimburse for its use in type 1 diabetes.

Paul Jellinger, M.D., is professor of clinical medicine at the University of Miami and an endocrinologist in Hollywood, Fla. He is on the speakers bureaus for Novo Nordisk, Boehringer Ingelheim, Janssen, Bristol-Myers Squibb, and Amarin. He was not involved in the study.

Title
Results show potential for GLP-1 agonists
Results show potential for GLP-1 agonists

LAS VEGAS – In patients with type 1 diabetes, adding a 1.8-mg daily dose of liraglutide to insulin significantly reduced hemoglobin A1c, mean blood glucose, body weight, carbohydrate intake, and C-reactive protein, in a randomized study.

The 72-patient study also showed that adding liraglutide (Victoza) significantly improved quality of life and reduced systolic blood pressure in the groups that were receiving higher doses of the medicine.

Naseem Miller/Frontline Medical News
Dr. Nitesh Kuhadiya

"Our findings have significant implications for the future treatment of type 1 diabetes," said Dr. Nitesh Kuhadiya of the State University of New York at Buffalo, who presented the findings at the annual meeting of the American Association of Clinical Endocrinologists. "Long term studies are needed to establish the durability of the effects."

In previous small, nonrandomized studies of patients with type 1 diabetes, liraglutide improved glycemic control and led to weight loss (Eur. J. Endocrinol. 2011;165:77-84; Endocr. Pract. 2013;19:963-7). They then decided to conduct a randomized controlled trial, which is the first of its kind, said Dr. Kuhadiya, who compared type 1 diabetes to a "wild horse that’s extremely difficult to tame and kicks you 10 times a day."

For the study, researchers randomized 72 patients to four groups to receive 0.6, 1.2, or 1.8 mg of liraglutide or a placebo daily for 12 weeks. One patient dropped out of placebo group, as well as five from the 1.2-mg and three from the 1.8-mg group.

The groups’ baseline characteristics were similar. All patients had type 1 diabetes for at least 1 year, were on insulin therapy, and had no detectable C-peptide in plasma. The mean age was 44 years, mean body weight was 83 kg, mean body mass index was 29 kg/m2, mean HbA1c was 7.5, and mean interval since diabetes diagnosis was 20 years. Nearly all (96%) patients were white and 56% were women.

There was a significant drop of nearly 10 mg/dL in average glucose in the 1.2- and 1.8-mg groups. The HbA1c, also dropped in those two groups, although it was significant in only the 1.2-mg group, by about 0.8%. The drop was 0.4% in 1.8-mg group, 0.2% in the 0.6-mg group, and 0.3% in the placebo subjects.

There were also significant changes in the percent time spent in different glycemic thresholds for the 1.8-mg group. 

Patients on 1.2 mg and 1.8 mg of liraglutide spent about 3%-5% more time in the 70- to 160-mg/dL zone, respectively, although only those on 1.8 mg reached statistical significance. 

Again, the 1.2- and 1.8-mg groups spent less time in hyperglycemia, defined as 160-240 mg/dL, Dr. Kuhadiya said. No significant changes were observed in the other two groups. 

A similar trend was seen for severe hyperglycemia (250 mg/dL). 

There was, however, some additional hypoglycemia in the study in the range of 55 to 70 mg/dL, Dr. Kuhadiya reported. The 1.2- and 1.8-mg groups spent significantly more time (nearly 1%) in that range, but there was no incidence of hypoglycemia in the placebo and 0.6-mg groups. The results were similar for the less than 50 mg/dL range. However, there was no incidence of hypoglycemia requiring hospitalization or medical attention, Dr. Kuhadiya said. 

All three groups receiving liraglutide showed significant weight loss: nearly 5 kg in the 1.2- and 1.8-mg groups, and 3 kg in the 0.6-mg group, over a period of 12 weeks. 

The carbohydrate intake for the 1.2- and 1.8-mg groups also dropped significantly. 

Dr. Kuhadiya said that the findings also show that all changes are independent of each other. 

All groups showed a fall in C-reactive protein, which is a marker for cardiovascular risk, although only the 1.8-mg groups showed a statistical significance. "And this is important because most patients with type 1 diabetes have metabolic syndrome, and to be able to demonstrate all these changes and an additional fall in CRP means further protection from cardiovascular risk," Dr. Kuhadiya said.

The study was funded by Novo Nordisk. Dr. Kuhadiya had no relevant disclosures.

nmiller@frontlinemedcom.com

On Twitter @naseemmiller

LAS VEGAS – In patients with type 1 diabetes, adding a 1.8-mg daily dose of liraglutide to insulin significantly reduced hemoglobin A1c, mean blood glucose, body weight, carbohydrate intake, and C-reactive protein, in a randomized study.

The 72-patient study also showed that adding liraglutide (Victoza) significantly improved quality of life and reduced systolic blood pressure in the groups that were receiving higher doses of the medicine.

Naseem Miller/Frontline Medical News
Dr. Nitesh Kuhadiya

"Our findings have significant implications for the future treatment of type 1 diabetes," said Dr. Nitesh Kuhadiya of the State University of New York at Buffalo, who presented the findings at the annual meeting of the American Association of Clinical Endocrinologists. "Long term studies are needed to establish the durability of the effects."

In previous small, nonrandomized studies of patients with type 1 diabetes, liraglutide improved glycemic control and led to weight loss (Eur. J. Endocrinol. 2011;165:77-84; Endocr. Pract. 2013;19:963-7). They then decided to conduct a randomized controlled trial, which is the first of its kind, said Dr. Kuhadiya, who compared type 1 diabetes to a "wild horse that’s extremely difficult to tame and kicks you 10 times a day."

For the study, researchers randomized 72 patients to four groups to receive 0.6, 1.2, or 1.8 mg of liraglutide or a placebo daily for 12 weeks. One patient dropped out of placebo group, as well as five from the 1.2-mg and three from the 1.8-mg group.

The groups’ baseline characteristics were similar. All patients had type 1 diabetes for at least 1 year, were on insulin therapy, and had no detectable C-peptide in plasma. The mean age was 44 years, mean body weight was 83 kg, mean body mass index was 29 kg/m2, mean HbA1c was 7.5, and mean interval since diabetes diagnosis was 20 years. Nearly all (96%) patients were white and 56% were women.

There was a significant drop of nearly 10 mg/dL in average glucose in the 1.2- and 1.8-mg groups. The HbA1c, also dropped in those two groups, although it was significant in only the 1.2-mg group, by about 0.8%. The drop was 0.4% in 1.8-mg group, 0.2% in the 0.6-mg group, and 0.3% in the placebo subjects.

There were also significant changes in the percent time spent in different glycemic thresholds for the 1.8-mg group. 

Patients on 1.2 mg and 1.8 mg of liraglutide spent about 3%-5% more time in the 70- to 160-mg/dL zone, respectively, although only those on 1.8 mg reached statistical significance. 

Again, the 1.2- and 1.8-mg groups spent less time in hyperglycemia, defined as 160-240 mg/dL, Dr. Kuhadiya said. No significant changes were observed in the other two groups. 

A similar trend was seen for severe hyperglycemia (250 mg/dL). 

There was, however, some additional hypoglycemia in the study in the range of 55 to 70 mg/dL, Dr. Kuhadiya reported. The 1.2- and 1.8-mg groups spent significantly more time (nearly 1%) in that range, but there was no incidence of hypoglycemia in the placebo and 0.6-mg groups. The results were similar for the less than 50 mg/dL range. However, there was no incidence of hypoglycemia requiring hospitalization or medical attention, Dr. Kuhadiya said. 

All three groups receiving liraglutide showed significant weight loss: nearly 5 kg in the 1.2- and 1.8-mg groups, and 3 kg in the 0.6-mg group, over a period of 12 weeks. 

The carbohydrate intake for the 1.2- and 1.8-mg groups also dropped significantly. 

Dr. Kuhadiya said that the findings also show that all changes are independent of each other. 

All groups showed a fall in C-reactive protein, which is a marker for cardiovascular risk, although only the 1.8-mg groups showed a statistical significance. "And this is important because most patients with type 1 diabetes have metabolic syndrome, and to be able to demonstrate all these changes and an additional fall in CRP means further protection from cardiovascular risk," Dr. Kuhadiya said.

The study was funded by Novo Nordisk. Dr. Kuhadiya had no relevant disclosures.

nmiller@frontlinemedcom.com

On Twitter @naseemmiller

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Liraglutide tested as add-on therapy for type 1 diabetes
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Key clinical point: Liraglutide may help type 1 diabetes patients control glucose and lose weight.

Major finding: There was a significant drop of nearly 10 mg/dL in average glucose in the 1.2-mg and 1.8-mg groups.

Data source: Randomized controlled trial of 72 patients receiving 0.6, 1.2, or 1.8 mg of liraglutide or a placebo daily for 12 weeks.

Disclosures: The study was funded by Novo Nordisk. Dr. Kuhadiya had no relevant disclosures.

‘Dramatic pace’ seen in progress toward bionic pancreas

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LAS VEGAS – Advances in developing a so-called bionic pancreas that seamlessly and automatically mimics pancreatic endocrine function in patients with diabetes is far ahead of projections, according to Dr. Jay S. Skyler.

More than 20 groups around the world are working on versions of a bionic pancreas, also known as an artificial pancreas, Dr. Skyler said at the annual meeting of the American Association of Clinical Endocrinologists. These devices combine a continuous glucose monitor, computer algorithms, and an insulin pump (and sometimes also a glucagon pump) to enable tight glucose control.

Dr. Jay S. Skyler

"The progress is moving at dramatic pace," said Dr. Skyler. He and his coauthors recently published a summary of the developments (Ann. N.Y. Acad. Sci. 2014;1311:102-23).

"The prediction when JDRF set up its road map for an artificial pancreas 2 years ago was we would achieve that by 2023. My bet is we achieve it sooner than that: Sometime in the next 3 years or so, we will have available for us to use bionic pancreases to allow excellent glucose control for our patients."

These devices have performed well in studies that have progressively moved them out of the lab and into the real world, according to Dr. Skyler, associate director of the Diabetes Research Institute, chairman of the Type 1 Diabetes TrialNet Clinical Trials Network, and professor of medicine, pediatrics, and psychology at the University of Miami.

One example is the MD-Logic Artificial Pancreas, which improved nocturnal glucose control among adolescents and teenagers at a summer camp (N. Engl. J. Med. 2013;368:824-33). "A lot of people played with these kinds of devices but always in the clinical research center or in the hospital. This was the first outpatient study that was done at a camp," he noted.

And in a study by the Diabetes Wireless Artificial Pancreas Consortium of patients at home,the device maintained glucose levels within a very tight range, with 95% of morning values falling between 110 and 140 mg/dL (Pediatr. Diab. 2013;14:159-167). "That is really a rather impressive achievement," Dr. Skyler said.

The Boston Bionic Pancreas has a receiver that attaches to an iPhone and two pumps, one delivering insulin and the other glucagon. Results in inpatients have shown good glycemic control over the course of the day (Diabetes Care 2012;35:2148-55).

When compared with usual insulin-pump therapy among 20 adult outpatients in the crossover Beacon Hill Study, the bionic pancreas yielded lower mean glucose levels as well as a decrease in the percentage of values falling within the hypoglycemic range (N. Engl. J. Med. 2014 June 15 [doi:10.1056/NEJMoa1314474]). Findings were similar among 32 youth at a summer camp.

The Virginia Closed-Loop Artificial Pancreas interfaces with an Android phone via the Diabetes Information Application and has an insulin pump. This device performed well among outpatients at a summer camp, with the time in range (defined as 70-150 mg/dL) increasing from 55% to 73%, and no excursions below 60 mg/dL (Diab. Technol. Ther. 2014;16 (Suppl 1):A-42)

In an outpatient overnight study, the time in range (defined as 80-150 mg/dL) during early morning hours increased from 39% under open-loop conditions (with user intervention) to 82% under closed-loop conditions (with no user intervention) (Kovatchev B et al. American Diabetes Association, 2013, Abstract 993-P).

The time spent at levels of less than 70 mg/dL fell from 2.0% to 0.6%.

Dr. Skyler disclosed that he was on the board of directors of Minimed (prior to acquisition by Medtronic) at the time of development of the first continuous glucose monitoring systems. He is currently on the board of directors of Dexcom and is an investor in Tandem Diabetes Care.

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LAS VEGAS – Advances in developing a so-called bionic pancreas that seamlessly and automatically mimics pancreatic endocrine function in patients with diabetes is far ahead of projections, according to Dr. Jay S. Skyler.

More than 20 groups around the world are working on versions of a bionic pancreas, also known as an artificial pancreas, Dr. Skyler said at the annual meeting of the American Association of Clinical Endocrinologists. These devices combine a continuous glucose monitor, computer algorithms, and an insulin pump (and sometimes also a glucagon pump) to enable tight glucose control.

Dr. Jay S. Skyler

"The progress is moving at dramatic pace," said Dr. Skyler. He and his coauthors recently published a summary of the developments (Ann. N.Y. Acad. Sci. 2014;1311:102-23).

"The prediction when JDRF set up its road map for an artificial pancreas 2 years ago was we would achieve that by 2023. My bet is we achieve it sooner than that: Sometime in the next 3 years or so, we will have available for us to use bionic pancreases to allow excellent glucose control for our patients."

These devices have performed well in studies that have progressively moved them out of the lab and into the real world, according to Dr. Skyler, associate director of the Diabetes Research Institute, chairman of the Type 1 Diabetes TrialNet Clinical Trials Network, and professor of medicine, pediatrics, and psychology at the University of Miami.

One example is the MD-Logic Artificial Pancreas, which improved nocturnal glucose control among adolescents and teenagers at a summer camp (N. Engl. J. Med. 2013;368:824-33). "A lot of people played with these kinds of devices but always in the clinical research center or in the hospital. This was the first outpatient study that was done at a camp," he noted.

And in a study by the Diabetes Wireless Artificial Pancreas Consortium of patients at home,the device maintained glucose levels within a very tight range, with 95% of morning values falling between 110 and 140 mg/dL (Pediatr. Diab. 2013;14:159-167). "That is really a rather impressive achievement," Dr. Skyler said.

The Boston Bionic Pancreas has a receiver that attaches to an iPhone and two pumps, one delivering insulin and the other glucagon. Results in inpatients have shown good glycemic control over the course of the day (Diabetes Care 2012;35:2148-55).

When compared with usual insulin-pump therapy among 20 adult outpatients in the crossover Beacon Hill Study, the bionic pancreas yielded lower mean glucose levels as well as a decrease in the percentage of values falling within the hypoglycemic range (N. Engl. J. Med. 2014 June 15 [doi:10.1056/NEJMoa1314474]). Findings were similar among 32 youth at a summer camp.

The Virginia Closed-Loop Artificial Pancreas interfaces with an Android phone via the Diabetes Information Application and has an insulin pump. This device performed well among outpatients at a summer camp, with the time in range (defined as 70-150 mg/dL) increasing from 55% to 73%, and no excursions below 60 mg/dL (Diab. Technol. Ther. 2014;16 (Suppl 1):A-42)

In an outpatient overnight study, the time in range (defined as 80-150 mg/dL) during early morning hours increased from 39% under open-loop conditions (with user intervention) to 82% under closed-loop conditions (with no user intervention) (Kovatchev B et al. American Diabetes Association, 2013, Abstract 993-P).

The time spent at levels of less than 70 mg/dL fell from 2.0% to 0.6%.

Dr. Skyler disclosed that he was on the board of directors of Minimed (prior to acquisition by Medtronic) at the time of development of the first continuous glucose monitoring systems. He is currently on the board of directors of Dexcom and is an investor in Tandem Diabetes Care.

LAS VEGAS – Advances in developing a so-called bionic pancreas that seamlessly and automatically mimics pancreatic endocrine function in patients with diabetes is far ahead of projections, according to Dr. Jay S. Skyler.

More than 20 groups around the world are working on versions of a bionic pancreas, also known as an artificial pancreas, Dr. Skyler said at the annual meeting of the American Association of Clinical Endocrinologists. These devices combine a continuous glucose monitor, computer algorithms, and an insulin pump (and sometimes also a glucagon pump) to enable tight glucose control.

Dr. Jay S. Skyler

"The progress is moving at dramatic pace," said Dr. Skyler. He and his coauthors recently published a summary of the developments (Ann. N.Y. Acad. Sci. 2014;1311:102-23).

"The prediction when JDRF set up its road map for an artificial pancreas 2 years ago was we would achieve that by 2023. My bet is we achieve it sooner than that: Sometime in the next 3 years or so, we will have available for us to use bionic pancreases to allow excellent glucose control for our patients."

These devices have performed well in studies that have progressively moved them out of the lab and into the real world, according to Dr. Skyler, associate director of the Diabetes Research Institute, chairman of the Type 1 Diabetes TrialNet Clinical Trials Network, and professor of medicine, pediatrics, and psychology at the University of Miami.

One example is the MD-Logic Artificial Pancreas, which improved nocturnal glucose control among adolescents and teenagers at a summer camp (N. Engl. J. Med. 2013;368:824-33). "A lot of people played with these kinds of devices but always in the clinical research center or in the hospital. This was the first outpatient study that was done at a camp," he noted.

And in a study by the Diabetes Wireless Artificial Pancreas Consortium of patients at home,the device maintained glucose levels within a very tight range, with 95% of morning values falling between 110 and 140 mg/dL (Pediatr. Diab. 2013;14:159-167). "That is really a rather impressive achievement," Dr. Skyler said.

The Boston Bionic Pancreas has a receiver that attaches to an iPhone and two pumps, one delivering insulin and the other glucagon. Results in inpatients have shown good glycemic control over the course of the day (Diabetes Care 2012;35:2148-55).

When compared with usual insulin-pump therapy among 20 adult outpatients in the crossover Beacon Hill Study, the bionic pancreas yielded lower mean glucose levels as well as a decrease in the percentage of values falling within the hypoglycemic range (N. Engl. J. Med. 2014 June 15 [doi:10.1056/NEJMoa1314474]). Findings were similar among 32 youth at a summer camp.

The Virginia Closed-Loop Artificial Pancreas interfaces with an Android phone via the Diabetes Information Application and has an insulin pump. This device performed well among outpatients at a summer camp, with the time in range (defined as 70-150 mg/dL) increasing from 55% to 73%, and no excursions below 60 mg/dL (Diab. Technol. Ther. 2014;16 (Suppl 1):A-42)

In an outpatient overnight study, the time in range (defined as 80-150 mg/dL) during early morning hours increased from 39% under open-loop conditions (with user intervention) to 82% under closed-loop conditions (with no user intervention) (Kovatchev B et al. American Diabetes Association, 2013, Abstract 993-P).

The time spent at levels of less than 70 mg/dL fell from 2.0% to 0.6%.

Dr. Skyler disclosed that he was on the board of directors of Minimed (prior to acquisition by Medtronic) at the time of development of the first continuous glucose monitoring systems. He is currently on the board of directors of Dexcom and is an investor in Tandem Diabetes Care.

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New obesity algorithm covers complications in addition to BMI

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LAS VEGAS– A newly introduced statement proposes to change how obesity is diagnosed and treated.

The American Association of Clinical Endocrinologists and the American College of Endocrinology are suggesting algorithms to determine stages for the disease, each of which comes with a set of therapy recommendations. 

"Right now it’s obesity, or overweight/obesity, or Class 1, 2, 3 obesity – it’s all [body mass index]. BMI doesn’t convey actionability. It doesn’t convey a medical meaning," said Dr. W. Timothy Garvey, chair of the AACE Obesity Scientific Committee at the annual meeting of the American Association of Clinical Endocrinologists.

Naseem Miller/Frontline Medical News
Dr. W. Timothy Garvey

AACE/ACE leaders hope that their new diagnostic algorithm will fill that gap.

"We’re using weight loss therapy to treat the complications of obesity in a medical model," Dr. Garvey said.

According to the framework, which is not finalized yet, the diagnostic categories of obesity will be:

• Overweight: BMI of 25-29.9 kg/m2, with no obesity-related complications.

• Obesity Stage 0: BMI of at least 30, with no obesity-related complications.

• Obesity Stage 1: BMI of at least 25 and one or more complications that are mild to moderate in severity.

• Obesity stage 2: BMI of greater than or equal to 25 and one or more severe complications.

Also, a four-step diagnosis and treatment approach is recommended for all patients:

1. BMI screening and adjusting for ethnic differences.

2. Clinical evaluation for the presence of obesity-related complications, by using a checklist.

3. Staging for the severity of complications using complication-specific criteria.

4. Selection of prevention and/or intervention strategies targeting specific complications guided by the AACE/ACE obesity management algorithm.

AACE/ACE leaders pointed out that today there are better tools to treat obesity than ever before, including improvements in lifestyle intervention, new medications, and improvements in bariatric surgery, yet there’s limited access and penetrance of these tools in the clinic. They said they hoped the new algorithm would help incorporate available therapies into treating obese patients.

The algorithm emerged from the AACE/ACE 2014 Consensus Conference on Obesity, which included medical professionals, industry representatives, advocacy groups, and regulators. One of the findings that everyone agreed on was that the diagnostic definition of obesity needed to improve.

The current definition of obesity "didn’t give all the stakeholders a reason to buy into a concerted plan." Employers would say, "I bring somebody down from a BMI of 38 to 34. But what does that mean? "How is it benefiting me? How is it benefiting my company? Why would I want to invest in that? But if they’re treating Stage 2, that’s telling them that that person is overweight, has excessive body fat, and it’s impacting their health and they have complications that can be remedied by weight loss and use of more aggressive therapies. All of that is embedded in that simple term," Dr. Garvey said. 

The AACE/ACE is not the first to issue a diagnosis or treatment guideline for obesity, which was declared a disease by the American Medical Association in 2013. 

There are a lot of commonalities to the guidelines," said Dr. Garvey, professor and chair at the department of Nutrition Sciences at the University of Alabama at Birmingham. They’re all addressing obesity and therapy and attempt to improve patients’ health. "I think we’re more focused on using weight loss as a therapy to treat obesity-related complications," Dr. Garvey said. 

AACE/ACE is holding another consensus conference later this year as a step toward finalizing the framework.

Dr. Garvey is a consultant for Daiichi Sankyo, Liposcience, Takeda, Vivus, Boehringer Ingelheim, Janssen, Eisai, and Novo Nordisk. He has received research funding from Merck, Astra Zeneca, Weight Watchers, Eisai, and Sanofi.

nmiller@frontlinemedcom.com

On Twitter @naseemmiller

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LAS VEGAS– A newly introduced statement proposes to change how obesity is diagnosed and treated.

The American Association of Clinical Endocrinologists and the American College of Endocrinology are suggesting algorithms to determine stages for the disease, each of which comes with a set of therapy recommendations. 

"Right now it’s obesity, or overweight/obesity, or Class 1, 2, 3 obesity – it’s all [body mass index]. BMI doesn’t convey actionability. It doesn’t convey a medical meaning," said Dr. W. Timothy Garvey, chair of the AACE Obesity Scientific Committee at the annual meeting of the American Association of Clinical Endocrinologists.

Naseem Miller/Frontline Medical News
Dr. W. Timothy Garvey

AACE/ACE leaders hope that their new diagnostic algorithm will fill that gap.

"We’re using weight loss therapy to treat the complications of obesity in a medical model," Dr. Garvey said.

According to the framework, which is not finalized yet, the diagnostic categories of obesity will be:

• Overweight: BMI of 25-29.9 kg/m2, with no obesity-related complications.

• Obesity Stage 0: BMI of at least 30, with no obesity-related complications.

• Obesity Stage 1: BMI of at least 25 and one or more complications that are mild to moderate in severity.

• Obesity stage 2: BMI of greater than or equal to 25 and one or more severe complications.

Also, a four-step diagnosis and treatment approach is recommended for all patients:

1. BMI screening and adjusting for ethnic differences.

2. Clinical evaluation for the presence of obesity-related complications, by using a checklist.

3. Staging for the severity of complications using complication-specific criteria.

4. Selection of prevention and/or intervention strategies targeting specific complications guided by the AACE/ACE obesity management algorithm.

AACE/ACE leaders pointed out that today there are better tools to treat obesity than ever before, including improvements in lifestyle intervention, new medications, and improvements in bariatric surgery, yet there’s limited access and penetrance of these tools in the clinic. They said they hoped the new algorithm would help incorporate available therapies into treating obese patients.

The algorithm emerged from the AACE/ACE 2014 Consensus Conference on Obesity, which included medical professionals, industry representatives, advocacy groups, and regulators. One of the findings that everyone agreed on was that the diagnostic definition of obesity needed to improve.

The current definition of obesity "didn’t give all the stakeholders a reason to buy into a concerted plan." Employers would say, "I bring somebody down from a BMI of 38 to 34. But what does that mean? "How is it benefiting me? How is it benefiting my company? Why would I want to invest in that? But if they’re treating Stage 2, that’s telling them that that person is overweight, has excessive body fat, and it’s impacting their health and they have complications that can be remedied by weight loss and use of more aggressive therapies. All of that is embedded in that simple term," Dr. Garvey said. 

The AACE/ACE is not the first to issue a diagnosis or treatment guideline for obesity, which was declared a disease by the American Medical Association in 2013. 

There are a lot of commonalities to the guidelines," said Dr. Garvey, professor and chair at the department of Nutrition Sciences at the University of Alabama at Birmingham. They’re all addressing obesity and therapy and attempt to improve patients’ health. "I think we’re more focused on using weight loss as a therapy to treat obesity-related complications," Dr. Garvey said. 

AACE/ACE is holding another consensus conference later this year as a step toward finalizing the framework.

Dr. Garvey is a consultant for Daiichi Sankyo, Liposcience, Takeda, Vivus, Boehringer Ingelheim, Janssen, Eisai, and Novo Nordisk. He has received research funding from Merck, Astra Zeneca, Weight Watchers, Eisai, and Sanofi.

nmiller@frontlinemedcom.com

On Twitter @naseemmiller

LAS VEGAS– A newly introduced statement proposes to change how obesity is diagnosed and treated.

The American Association of Clinical Endocrinologists and the American College of Endocrinology are suggesting algorithms to determine stages for the disease, each of which comes with a set of therapy recommendations. 

"Right now it’s obesity, or overweight/obesity, or Class 1, 2, 3 obesity – it’s all [body mass index]. BMI doesn’t convey actionability. It doesn’t convey a medical meaning," said Dr. W. Timothy Garvey, chair of the AACE Obesity Scientific Committee at the annual meeting of the American Association of Clinical Endocrinologists.

Naseem Miller/Frontline Medical News
Dr. W. Timothy Garvey

AACE/ACE leaders hope that their new diagnostic algorithm will fill that gap.

"We’re using weight loss therapy to treat the complications of obesity in a medical model," Dr. Garvey said.

According to the framework, which is not finalized yet, the diagnostic categories of obesity will be:

• Overweight: BMI of 25-29.9 kg/m2, with no obesity-related complications.

• Obesity Stage 0: BMI of at least 30, with no obesity-related complications.

• Obesity Stage 1: BMI of at least 25 and one or more complications that are mild to moderate in severity.

• Obesity stage 2: BMI of greater than or equal to 25 and one or more severe complications.

Also, a four-step diagnosis and treatment approach is recommended for all patients:

1. BMI screening and adjusting for ethnic differences.

2. Clinical evaluation for the presence of obesity-related complications, by using a checklist.

3. Staging for the severity of complications using complication-specific criteria.

4. Selection of prevention and/or intervention strategies targeting specific complications guided by the AACE/ACE obesity management algorithm.

AACE/ACE leaders pointed out that today there are better tools to treat obesity than ever before, including improvements in lifestyle intervention, new medications, and improvements in bariatric surgery, yet there’s limited access and penetrance of these tools in the clinic. They said they hoped the new algorithm would help incorporate available therapies into treating obese patients.

The algorithm emerged from the AACE/ACE 2014 Consensus Conference on Obesity, which included medical professionals, industry representatives, advocacy groups, and regulators. One of the findings that everyone agreed on was that the diagnostic definition of obesity needed to improve.

The current definition of obesity "didn’t give all the stakeholders a reason to buy into a concerted plan." Employers would say, "I bring somebody down from a BMI of 38 to 34. But what does that mean? "How is it benefiting me? How is it benefiting my company? Why would I want to invest in that? But if they’re treating Stage 2, that’s telling them that that person is overweight, has excessive body fat, and it’s impacting their health and they have complications that can be remedied by weight loss and use of more aggressive therapies. All of that is embedded in that simple term," Dr. Garvey said. 

The AACE/ACE is not the first to issue a diagnosis or treatment guideline for obesity, which was declared a disease by the American Medical Association in 2013. 

There are a lot of commonalities to the guidelines," said Dr. Garvey, professor and chair at the department of Nutrition Sciences at the University of Alabama at Birmingham. They’re all addressing obesity and therapy and attempt to improve patients’ health. "I think we’re more focused on using weight loss as a therapy to treat obesity-related complications," Dr. Garvey said. 

AACE/ACE is holding another consensus conference later this year as a step toward finalizing the framework.

Dr. Garvey is a consultant for Daiichi Sankyo, Liposcience, Takeda, Vivus, Boehringer Ingelheim, Janssen, Eisai, and Novo Nordisk. He has received research funding from Merck, Astra Zeneca, Weight Watchers, Eisai, and Sanofi.

nmiller@frontlinemedcom.com

On Twitter @naseemmiller

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VIDEO: Endocrinology initiatives can improve transgender care

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LAS VEGAS – Dr. Joshua D. Safer is a man on a mission. He wants to incorporate transgender medicine into medical school curricula across North America to help increase the number of specialists who can treat individuals with gender identity disorders.

"The number of endocrinologists who do this is very small," said Dr. Safer of the departments of medicine and molecular medicine and director of the endocrinology fellowship training program at Boston University. This is partly because many physicians aren’t comfortable with the topic, said Dr. Safer. Endocrinologists should recognize that "gender identity is usually fixed," and once they accept this fact, hormone treatment for transgender individuals "follows a conventional endocrinology paradigm," he said at the annual meeting of the American Association of Clinical Endocrinologists.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

By his count, there may be a dozen endocrinologists in the United States who specialize in transgender medicine. Yet, some statistics suggest that 0.3% of the population has gender identity disorder, Dr. Safer noted, "and that’s not a small number – you’re talking about hundreds of thousands of people." Also, the age of Internet and social media has helped transgender individuals recognize that they’re not alone in their battle, and "many are showing up at a younger age," he added.

Several protocols are available for physicians, including one published by the Endocrine Society and another by the World Professional Association for Transgender Health (WPATH), which is one of the oldest organizations to focus on understanding and treatment of gender identity disorders. Both groups are working to create treatment paradigms that are reproducible by physicians in multiple specialties, Dr. Safer said. The American Congress of Obstetricians and Gynecologists also has a complete list of available resources.

Dr. Safer said that endocrinologists can also contact experts like him for advice. (For instance, Dr. Safer works closely with a mental health counselor who helps patients navigate their way through the changes.)

In the meantime, he continues to give talks around the nation to raise awareness and is planning on conducting studies and surveying physicians on their knowledge of the field. Transgender medicine is already incorporated into Boston University’s medical school curriculum, he said.

Dr. Safer has no relevant financial relationships with commercial interests.

nmiller@frontlinemedcom.com

On Twitter @naseemmiller

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LAS VEGAS – Dr. Joshua D. Safer is a man on a mission. He wants to incorporate transgender medicine into medical school curricula across North America to help increase the number of specialists who can treat individuals with gender identity disorders.

"The number of endocrinologists who do this is very small," said Dr. Safer of the departments of medicine and molecular medicine and director of the endocrinology fellowship training program at Boston University. This is partly because many physicians aren’t comfortable with the topic, said Dr. Safer. Endocrinologists should recognize that "gender identity is usually fixed," and once they accept this fact, hormone treatment for transgender individuals "follows a conventional endocrinology paradigm," he said at the annual meeting of the American Association of Clinical Endocrinologists.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

By his count, there may be a dozen endocrinologists in the United States who specialize in transgender medicine. Yet, some statistics suggest that 0.3% of the population has gender identity disorder, Dr. Safer noted, "and that’s not a small number – you’re talking about hundreds of thousands of people." Also, the age of Internet and social media has helped transgender individuals recognize that they’re not alone in their battle, and "many are showing up at a younger age," he added.

Several protocols are available for physicians, including one published by the Endocrine Society and another by the World Professional Association for Transgender Health (WPATH), which is one of the oldest organizations to focus on understanding and treatment of gender identity disorders. Both groups are working to create treatment paradigms that are reproducible by physicians in multiple specialties, Dr. Safer said. The American Congress of Obstetricians and Gynecologists also has a complete list of available resources.

Dr. Safer said that endocrinologists can also contact experts like him for advice. (For instance, Dr. Safer works closely with a mental health counselor who helps patients navigate their way through the changes.)

In the meantime, he continues to give talks around the nation to raise awareness and is planning on conducting studies and surveying physicians on their knowledge of the field. Transgender medicine is already incorporated into Boston University’s medical school curriculum, he said.

Dr. Safer has no relevant financial relationships with commercial interests.

nmiller@frontlinemedcom.com

On Twitter @naseemmiller

LAS VEGAS – Dr. Joshua D. Safer is a man on a mission. He wants to incorporate transgender medicine into medical school curricula across North America to help increase the number of specialists who can treat individuals with gender identity disorders.

"The number of endocrinologists who do this is very small," said Dr. Safer of the departments of medicine and molecular medicine and director of the endocrinology fellowship training program at Boston University. This is partly because many physicians aren’t comfortable with the topic, said Dr. Safer. Endocrinologists should recognize that "gender identity is usually fixed," and once they accept this fact, hormone treatment for transgender individuals "follows a conventional endocrinology paradigm," he said at the annual meeting of the American Association of Clinical Endocrinologists.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

By his count, there may be a dozen endocrinologists in the United States who specialize in transgender medicine. Yet, some statistics suggest that 0.3% of the population has gender identity disorder, Dr. Safer noted, "and that’s not a small number – you’re talking about hundreds of thousands of people." Also, the age of Internet and social media has helped transgender individuals recognize that they’re not alone in their battle, and "many are showing up at a younger age," he added.

Several protocols are available for physicians, including one published by the Endocrine Society and another by the World Professional Association for Transgender Health (WPATH), which is one of the oldest organizations to focus on understanding and treatment of gender identity disorders. Both groups are working to create treatment paradigms that are reproducible by physicians in multiple specialties, Dr. Safer said. The American Congress of Obstetricians and Gynecologists also has a complete list of available resources.

Dr. Safer said that endocrinologists can also contact experts like him for advice. (For instance, Dr. Safer works closely with a mental health counselor who helps patients navigate their way through the changes.)

In the meantime, he continues to give talks around the nation to raise awareness and is planning on conducting studies and surveying physicians on their knowledge of the field. Transgender medicine is already incorporated into Boston University’s medical school curriculum, he said.

Dr. Safer has no relevant financial relationships with commercial interests.

nmiller@frontlinemedcom.com

On Twitter @naseemmiller

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VIDEO: Hypogonadism, hypercortisolemia may mean anorexia in men

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VIDEO: Hypogonadism, hypercortisolemia may mean anorexia in men

LAS VEGAS – Anorexia nervosa in men may present in unusual ways, confounding the diagnosis and leading to inappropriate treatment, according to a case series reported at the annual meeting of the American Association of Clinical Endocrinologists.

In a video interview, Dr. Aren H. Skolnick, an endocrinology fellow at Hofstra University, Hempstead, N.Y., Jewish Medical Center, explains the signs of anorexia in men, how the condition presents itself, and what clinicians should do.

nmiller@frontlinemedcom.com

On Twitter @naseemmiller

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
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LAS VEGAS – Anorexia nervosa in men may present in unusual ways, confounding the diagnosis and leading to inappropriate treatment, according to a case series reported at the annual meeting of the American Association of Clinical Endocrinologists.

In a video interview, Dr. Aren H. Skolnick, an endocrinology fellow at Hofstra University, Hempstead, N.Y., Jewish Medical Center, explains the signs of anorexia in men, how the condition presents itself, and what clinicians should do.

nmiller@frontlinemedcom.com

On Twitter @naseemmiller

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

LAS VEGAS – Anorexia nervosa in men may present in unusual ways, confounding the diagnosis and leading to inappropriate treatment, according to a case series reported at the annual meeting of the American Association of Clinical Endocrinologists.

In a video interview, Dr. Aren H. Skolnick, an endocrinology fellow at Hofstra University, Hempstead, N.Y., Jewish Medical Center, explains the signs of anorexia in men, how the condition presents itself, and what clinicians should do.

nmiller@frontlinemedcom.com

On Twitter @naseemmiller

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
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VIDEO: Coffee break at AACE – What I’ve learned

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LAS VEGAS – With so many sessions to attend, we were curious what stood out to attendees at the annual meeting of the American Association of Clinical Endocrinologists.

In this video, attendees share the lessons they learned that they will be applying to their practices.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

nmiller@frontlinemedcom.com

On Twitter @naseemmiller

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LAS VEGAS – With so many sessions to attend, we were curious what stood out to attendees at the annual meeting of the American Association of Clinical Endocrinologists.

In this video, attendees share the lessons they learned that they will be applying to their practices.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

nmiller@frontlinemedcom.com

On Twitter @naseemmiller

LAS VEGAS – With so many sessions to attend, we were curious what stood out to attendees at the annual meeting of the American Association of Clinical Endocrinologists.

In this video, attendees share the lessons they learned that they will be applying to their practices.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

nmiller@frontlinemedcom.com

On Twitter @naseemmiller

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Atypical Presentation of Anorexia in Men

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Atypical Presentation of Anorexia in Men

LAS VEGAS – Anorexia nervosa in men may present in unusual ways, confounding the diagnosis and leading to inappropriate treatment, suggests a case series reported at the annual meeting of the American Association of Clinical Endocrinologists.

The four men, who ranged in age from 21 to 24 years, were seen in the emergency department with abnormal thyroid function test results, hypogonadism, and hypercortisolemia, according to data reported in a poster. Their symptoms included bradycardia (with heart rates in the 20s and 30s), gastroparesis, hypothermia, acute systolic heart failure, and erectile dysfunction.

"Only one of the cases had a prior diagnosis of anorexia, so it was kind of a mystery to everyone when they came in," first author Dr. Aren H. Skolnick said in a press briefing.

Some of the men were transferred to the cardiac care unit. Two were scheduled for cardiac pacemaker implantation, and one was scheduled for gastric pacemaker implantation before endocrinologists delved further into their history and made the correct diagnosis of anorexia.

"When we think of anorexia, we think of young women with eating disorders. No one really thinks about the guy with anorexia," said Dr. Skolnick, an endocrinology fellow at Hofstra North Shore-LIJ School of Medicine, Long Island (New York) Jewish Medical Center. "These patients were going to go for invasive procedures that they didn’t need, so [anorexia] really needs to be on the differential diagnosis, at least for anyone coming in with any of these endocrinopathies who you suspect may have had weight loss or are malnourished."

Most of the patients’ symptoms resolved with improved caloric intake and nutrition, although it hasn’t been smooth sailing in all cases, Dr. Skolnick said. "The best treatment we know of is nutrition – getting these people fed," he maintained. Although studies have looked at treatment with recombinant growth hormone, recombinant insulinlike growth factor-1 (IGF-1), estrogen for women, and thyroid hormone, "hormone therapy isn’t appropriate most of the time."

Some data suggest that men account for only about 10% of patients with anorexia, but they probably make up more like 25% because of underreporting and misdiagnosis, In fact, one of the diagnostic criteria in the DSM-IV is amenorrhea, "but there are no criteria for hypogonadal symptoms for men, so there is a bias even with the diagnostic criteria."

Male anorexia – sometimes termed "manorexia" – and female anorexia share similar risk factors, but their features differ somewhat. "Women tend to strive for thinness; men strive for a more muscular appearance. Women tend to have a little more of the laxative use or purging type; men are the more excessive exercise type," he explained.

There is also a sex disparity in treatment benefit. "Women tend to benefit more from treatment, possibly because they are picked up earlier," Dr. Skolnick elaborated. "There is more social support for them; people know how to treat female anorexia. And people aren’t picking up on the male anorexia, so they are coming to physicians later and their cases are may be more severe, or people don’t feel comfortable dealing with it."

Patients can develop a variety of endocrinopathies that may trigger endocrinology consults. Anorexia can affect the hypothalamic-pituitary axis, including the gonadal axis, leading to hypogonadal symptoms; the pituitary-thyroid axis; growth hormone or IGF-1, leading to impaired growth in children and adolescents; and the adrenal axis.

Dr. Skolnick and his colleagues were asked to consult on the patients because their laboratory findings were inconsistent. "Some of them had a sick euthyroid type of hypothyroidism, where their TSH may be borderline low-normal, with a low T3 or T4, which is why they called us, because they weren’t sure what was going on. In addition, they had symptoms of hypogonadism, low testosterone on labs, and cortisol resistance or increased cortisol because of the stress," he explained.

The endocrinologists’ differential diagnosis consisted of anorexia, depression, and malingering. Detailed histories revealed that the patients had a weight loss of up to 113 pounds over the past few months; therefore, they had severe protein and caloric malnourishment. They also reported depression, not eating, and exercising a lot; one said he had been using a fat-reducing agent.

Dr. Skolnick disclosed no relevant conflicts of interest.

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LAS VEGAS – Anorexia nervosa in men may present in unusual ways, confounding the diagnosis and leading to inappropriate treatment, suggests a case series reported at the annual meeting of the American Association of Clinical Endocrinologists.

The four men, who ranged in age from 21 to 24 years, were seen in the emergency department with abnormal thyroid function test results, hypogonadism, and hypercortisolemia, according to data reported in a poster. Their symptoms included bradycardia (with heart rates in the 20s and 30s), gastroparesis, hypothermia, acute systolic heart failure, and erectile dysfunction.

"Only one of the cases had a prior diagnosis of anorexia, so it was kind of a mystery to everyone when they came in," first author Dr. Aren H. Skolnick said in a press briefing.

Some of the men were transferred to the cardiac care unit. Two were scheduled for cardiac pacemaker implantation, and one was scheduled for gastric pacemaker implantation before endocrinologists delved further into their history and made the correct diagnosis of anorexia.

"When we think of anorexia, we think of young women with eating disorders. No one really thinks about the guy with anorexia," said Dr. Skolnick, an endocrinology fellow at Hofstra North Shore-LIJ School of Medicine, Long Island (New York) Jewish Medical Center. "These patients were going to go for invasive procedures that they didn’t need, so [anorexia] really needs to be on the differential diagnosis, at least for anyone coming in with any of these endocrinopathies who you suspect may have had weight loss or are malnourished."

Most of the patients’ symptoms resolved with improved caloric intake and nutrition, although it hasn’t been smooth sailing in all cases, Dr. Skolnick said. "The best treatment we know of is nutrition – getting these people fed," he maintained. Although studies have looked at treatment with recombinant growth hormone, recombinant insulinlike growth factor-1 (IGF-1), estrogen for women, and thyroid hormone, "hormone therapy isn’t appropriate most of the time."

Some data suggest that men account for only about 10% of patients with anorexia, but they probably make up more like 25% because of underreporting and misdiagnosis, In fact, one of the diagnostic criteria in the DSM-IV is amenorrhea, "but there are no criteria for hypogonadal symptoms for men, so there is a bias even with the diagnostic criteria."

Male anorexia – sometimes termed "manorexia" – and female anorexia share similar risk factors, but their features differ somewhat. "Women tend to strive for thinness; men strive for a more muscular appearance. Women tend to have a little more of the laxative use or purging type; men are the more excessive exercise type," he explained.

There is also a sex disparity in treatment benefit. "Women tend to benefit more from treatment, possibly because they are picked up earlier," Dr. Skolnick elaborated. "There is more social support for them; people know how to treat female anorexia. And people aren’t picking up on the male anorexia, so they are coming to physicians later and their cases are may be more severe, or people don’t feel comfortable dealing with it."

Patients can develop a variety of endocrinopathies that may trigger endocrinology consults. Anorexia can affect the hypothalamic-pituitary axis, including the gonadal axis, leading to hypogonadal symptoms; the pituitary-thyroid axis; growth hormone or IGF-1, leading to impaired growth in children and adolescents; and the adrenal axis.

Dr. Skolnick and his colleagues were asked to consult on the patients because their laboratory findings were inconsistent. "Some of them had a sick euthyroid type of hypothyroidism, where their TSH may be borderline low-normal, with a low T3 or T4, which is why they called us, because they weren’t sure what was going on. In addition, they had symptoms of hypogonadism, low testosterone on labs, and cortisol resistance or increased cortisol because of the stress," he explained.

The endocrinologists’ differential diagnosis consisted of anorexia, depression, and malingering. Detailed histories revealed that the patients had a weight loss of up to 113 pounds over the past few months; therefore, they had severe protein and caloric malnourishment. They also reported depression, not eating, and exercising a lot; one said he had been using a fat-reducing agent.

Dr. Skolnick disclosed no relevant conflicts of interest.

LAS VEGAS – Anorexia nervosa in men may present in unusual ways, confounding the diagnosis and leading to inappropriate treatment, suggests a case series reported at the annual meeting of the American Association of Clinical Endocrinologists.

The four men, who ranged in age from 21 to 24 years, were seen in the emergency department with abnormal thyroid function test results, hypogonadism, and hypercortisolemia, according to data reported in a poster. Their symptoms included bradycardia (with heart rates in the 20s and 30s), gastroparesis, hypothermia, acute systolic heart failure, and erectile dysfunction.

"Only one of the cases had a prior diagnosis of anorexia, so it was kind of a mystery to everyone when they came in," first author Dr. Aren H. Skolnick said in a press briefing.

Some of the men were transferred to the cardiac care unit. Two were scheduled for cardiac pacemaker implantation, and one was scheduled for gastric pacemaker implantation before endocrinologists delved further into their history and made the correct diagnosis of anorexia.

"When we think of anorexia, we think of young women with eating disorders. No one really thinks about the guy with anorexia," said Dr. Skolnick, an endocrinology fellow at Hofstra North Shore-LIJ School of Medicine, Long Island (New York) Jewish Medical Center. "These patients were going to go for invasive procedures that they didn’t need, so [anorexia] really needs to be on the differential diagnosis, at least for anyone coming in with any of these endocrinopathies who you suspect may have had weight loss or are malnourished."

Most of the patients’ symptoms resolved with improved caloric intake and nutrition, although it hasn’t been smooth sailing in all cases, Dr. Skolnick said. "The best treatment we know of is nutrition – getting these people fed," he maintained. Although studies have looked at treatment with recombinant growth hormone, recombinant insulinlike growth factor-1 (IGF-1), estrogen for women, and thyroid hormone, "hormone therapy isn’t appropriate most of the time."

Some data suggest that men account for only about 10% of patients with anorexia, but they probably make up more like 25% because of underreporting and misdiagnosis, In fact, one of the diagnostic criteria in the DSM-IV is amenorrhea, "but there are no criteria for hypogonadal symptoms for men, so there is a bias even with the diagnostic criteria."

Male anorexia – sometimes termed "manorexia" – and female anorexia share similar risk factors, but their features differ somewhat. "Women tend to strive for thinness; men strive for a more muscular appearance. Women tend to have a little more of the laxative use or purging type; men are the more excessive exercise type," he explained.

There is also a sex disparity in treatment benefit. "Women tend to benefit more from treatment, possibly because they are picked up earlier," Dr. Skolnick elaborated. "There is more social support for them; people know how to treat female anorexia. And people aren’t picking up on the male anorexia, so they are coming to physicians later and their cases are may be more severe, or people don’t feel comfortable dealing with it."

Patients can develop a variety of endocrinopathies that may trigger endocrinology consults. Anorexia can affect the hypothalamic-pituitary axis, including the gonadal axis, leading to hypogonadal symptoms; the pituitary-thyroid axis; growth hormone or IGF-1, leading to impaired growth in children and adolescents; and the adrenal axis.

Dr. Skolnick and his colleagues were asked to consult on the patients because their laboratory findings were inconsistent. "Some of them had a sick euthyroid type of hypothyroidism, where their TSH may be borderline low-normal, with a low T3 or T4, which is why they called us, because they weren’t sure what was going on. In addition, they had symptoms of hypogonadism, low testosterone on labs, and cortisol resistance or increased cortisol because of the stress," he explained.

The endocrinologists’ differential diagnosis consisted of anorexia, depression, and malingering. Detailed histories revealed that the patients had a weight loss of up to 113 pounds over the past few months; therefore, they had severe protein and caloric malnourishment. They also reported depression, not eating, and exercising a lot; one said he had been using a fat-reducing agent.

Dr. Skolnick disclosed no relevant conflicts of interest.

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Atypical presentation of anorexia in men can lead to missed diagnosis

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LAS VEGAS – Anorexia nervosa in men may present in unusual ways, confounding the diagnosis and leading to inappropriate treatment, suggests a case series reported at the annual meeting of the American Association of Clinical Endocrinologists.

The four men, who ranged in age from 21 to 24 years, were seen in the emergency department with abnormal thyroid function test results, hypogonadism, and hypercortisolemia, according to data reported in a poster. Their symptoms included bradycardia (with heart rates in the 20s and 30s), gastroparesis, hypothermia, acute systolic heart failure, and erectile dysfunction.

"Only one of the cases had a prior diagnosis of anorexia, so it was kind of a mystery to everyone when they came in," first author Dr. Aren H. Skolnick said in a press briefing.

Some of the men were transferred to the cardiac care unit. Two were scheduled for cardiac pacemaker implantation, and one was scheduled for gastric pacemaker implantation before endocrinologists delved further into their history and made the correct diagnosis of anorexia.

"When we think of anorexia, we think of young women with eating disorders. No one really thinks about the guy with anorexia," said Dr. Skolnick, an endocrinology fellow at Hofstra North Shore-LIJ School of Medicine, Long Island (New York) Jewish Medical Center. "These patients were going to go for invasive procedures that they didn’t need, so [anorexia] really needs to be on the differential diagnosis, at least for anyone coming in with any of these endocrinopathies who you suspect may have had weight loss or are malnourished."

Most of the patients’ symptoms resolved with improved caloric intake and nutrition, although it hasn’t been smooth sailing in all cases, Dr. Skolnick said. "The best treatment we know of is nutrition – getting these people fed," he maintained. Although studies have looked at treatment with recombinant growth hormone, recombinant insulinlike growth factor-1 (IGF-1), estrogen for women, and thyroid hormone, "hormone therapy isn’t appropriate most of the time."

Some data suggest that men account for only about 10% of patients with anorexia, but they probably make up more like 25% because of underreporting and misdiagnosis, In fact, one of the diagnostic criteria in the DSM-IV is amenorrhea, "but there are no criteria for hypogonadal symptoms for men, so there is a bias even with the diagnostic criteria."

Male anorexia – sometimes termed "manorexia" – and female anorexia share similar risk factors, but their features differ somewhat. "Women tend to strive for thinness; men strive for a more muscular appearance. Women tend to have a little more of the laxative use or purging type; men are the more excessive exercise type," he explained.

There is also a sex disparity in treatment benefit. "Women tend to benefit more from treatment, possibly because they are picked up earlier," Dr. Skolnick elaborated. "There is more social support for them; people know how to treat female anorexia. And people aren’t picking up on the male anorexia, so they are coming to physicians later and their cases are may be more severe, or people don’t feel comfortable dealing with it."

Patients can develop a variety of endocrinopathies that may trigger endocrinology consults. Anorexia can affect the hypothalamic-pituitary axis, including the gonadal axis, leading to hypogonadal symptoms; the pituitary-thyroid axis; growth hormone or IGF-1, leading to impaired growth in children and adolescents; and the adrenal axis.

Dr. Skolnick and his colleagues were asked to consult on the patients because their laboratory findings were inconsistent. "Some of them had a sick euthyroid type of hypothyroidism, where their TSH may be borderline low-normal, with a low T3 or T4, which is why they called us, because they weren’t sure what was going on. In addition, they had symptoms of hypogonadism, low testosterone on labs, and cortisol resistance or increased cortisol because of the stress," he explained.

The endocrinologists’ differential diagnosis consisted of anorexia, depression, and malingering. Detailed histories revealed that the patients had a weight loss of up to 113 pounds over the past few months; therefore, they had severe protein and caloric malnourishment. They also reported depression, not eating, and exercising a lot; one said he had been using a fat-reducing agent.

Dr. Skolnick disclosed no relevant conflicts of interest.

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LAS VEGAS – Anorexia nervosa in men may present in unusual ways, confounding the diagnosis and leading to inappropriate treatment, suggests a case series reported at the annual meeting of the American Association of Clinical Endocrinologists.

The four men, who ranged in age from 21 to 24 years, were seen in the emergency department with abnormal thyroid function test results, hypogonadism, and hypercortisolemia, according to data reported in a poster. Their symptoms included bradycardia (with heart rates in the 20s and 30s), gastroparesis, hypothermia, acute systolic heart failure, and erectile dysfunction.

"Only one of the cases had a prior diagnosis of anorexia, so it was kind of a mystery to everyone when they came in," first author Dr. Aren H. Skolnick said in a press briefing.

Some of the men were transferred to the cardiac care unit. Two were scheduled for cardiac pacemaker implantation, and one was scheduled for gastric pacemaker implantation before endocrinologists delved further into their history and made the correct diagnosis of anorexia.

"When we think of anorexia, we think of young women with eating disorders. No one really thinks about the guy with anorexia," said Dr. Skolnick, an endocrinology fellow at Hofstra North Shore-LIJ School of Medicine, Long Island (New York) Jewish Medical Center. "These patients were going to go for invasive procedures that they didn’t need, so [anorexia] really needs to be on the differential diagnosis, at least for anyone coming in with any of these endocrinopathies who you suspect may have had weight loss or are malnourished."

Most of the patients’ symptoms resolved with improved caloric intake and nutrition, although it hasn’t been smooth sailing in all cases, Dr. Skolnick said. "The best treatment we know of is nutrition – getting these people fed," he maintained. Although studies have looked at treatment with recombinant growth hormone, recombinant insulinlike growth factor-1 (IGF-1), estrogen for women, and thyroid hormone, "hormone therapy isn’t appropriate most of the time."

Some data suggest that men account for only about 10% of patients with anorexia, but they probably make up more like 25% because of underreporting and misdiagnosis, In fact, one of the diagnostic criteria in the DSM-IV is amenorrhea, "but there are no criteria for hypogonadal symptoms for men, so there is a bias even with the diagnostic criteria."

Male anorexia – sometimes termed "manorexia" – and female anorexia share similar risk factors, but their features differ somewhat. "Women tend to strive for thinness; men strive for a more muscular appearance. Women tend to have a little more of the laxative use or purging type; men are the more excessive exercise type," he explained.

There is also a sex disparity in treatment benefit. "Women tend to benefit more from treatment, possibly because they are picked up earlier," Dr. Skolnick elaborated. "There is more social support for them; people know how to treat female anorexia. And people aren’t picking up on the male anorexia, so they are coming to physicians later and their cases are may be more severe, or people don’t feel comfortable dealing with it."

Patients can develop a variety of endocrinopathies that may trigger endocrinology consults. Anorexia can affect the hypothalamic-pituitary axis, including the gonadal axis, leading to hypogonadal symptoms; the pituitary-thyroid axis; growth hormone or IGF-1, leading to impaired growth in children and adolescents; and the adrenal axis.

Dr. Skolnick and his colleagues were asked to consult on the patients because their laboratory findings were inconsistent. "Some of them had a sick euthyroid type of hypothyroidism, where their TSH may be borderline low-normal, with a low T3 or T4, which is why they called us, because they weren’t sure what was going on. In addition, they had symptoms of hypogonadism, low testosterone on labs, and cortisol resistance or increased cortisol because of the stress," he explained.

The endocrinologists’ differential diagnosis consisted of anorexia, depression, and malingering. Detailed histories revealed that the patients had a weight loss of up to 113 pounds over the past few months; therefore, they had severe protein and caloric malnourishment. They also reported depression, not eating, and exercising a lot; one said he had been using a fat-reducing agent.

Dr. Skolnick disclosed no relevant conflicts of interest.

LAS VEGAS – Anorexia nervosa in men may present in unusual ways, confounding the diagnosis and leading to inappropriate treatment, suggests a case series reported at the annual meeting of the American Association of Clinical Endocrinologists.

The four men, who ranged in age from 21 to 24 years, were seen in the emergency department with abnormal thyroid function test results, hypogonadism, and hypercortisolemia, according to data reported in a poster. Their symptoms included bradycardia (with heart rates in the 20s and 30s), gastroparesis, hypothermia, acute systolic heart failure, and erectile dysfunction.

"Only one of the cases had a prior diagnosis of anorexia, so it was kind of a mystery to everyone when they came in," first author Dr. Aren H. Skolnick said in a press briefing.

Some of the men were transferred to the cardiac care unit. Two were scheduled for cardiac pacemaker implantation, and one was scheduled for gastric pacemaker implantation before endocrinologists delved further into their history and made the correct diagnosis of anorexia.

"When we think of anorexia, we think of young women with eating disorders. No one really thinks about the guy with anorexia," said Dr. Skolnick, an endocrinology fellow at Hofstra North Shore-LIJ School of Medicine, Long Island (New York) Jewish Medical Center. "These patients were going to go for invasive procedures that they didn’t need, so [anorexia] really needs to be on the differential diagnosis, at least for anyone coming in with any of these endocrinopathies who you suspect may have had weight loss or are malnourished."

Most of the patients’ symptoms resolved with improved caloric intake and nutrition, although it hasn’t been smooth sailing in all cases, Dr. Skolnick said. "The best treatment we know of is nutrition – getting these people fed," he maintained. Although studies have looked at treatment with recombinant growth hormone, recombinant insulinlike growth factor-1 (IGF-1), estrogen for women, and thyroid hormone, "hormone therapy isn’t appropriate most of the time."

Some data suggest that men account for only about 10% of patients with anorexia, but they probably make up more like 25% because of underreporting and misdiagnosis, In fact, one of the diagnostic criteria in the DSM-IV is amenorrhea, "but there are no criteria for hypogonadal symptoms for men, so there is a bias even with the diagnostic criteria."

Male anorexia – sometimes termed "manorexia" – and female anorexia share similar risk factors, but their features differ somewhat. "Women tend to strive for thinness; men strive for a more muscular appearance. Women tend to have a little more of the laxative use or purging type; men are the more excessive exercise type," he explained.

There is also a sex disparity in treatment benefit. "Women tend to benefit more from treatment, possibly because they are picked up earlier," Dr. Skolnick elaborated. "There is more social support for them; people know how to treat female anorexia. And people aren’t picking up on the male anorexia, so they are coming to physicians later and their cases are may be more severe, or people don’t feel comfortable dealing with it."

Patients can develop a variety of endocrinopathies that may trigger endocrinology consults. Anorexia can affect the hypothalamic-pituitary axis, including the gonadal axis, leading to hypogonadal symptoms; the pituitary-thyroid axis; growth hormone or IGF-1, leading to impaired growth in children and adolescents; and the adrenal axis.

Dr. Skolnick and his colleagues were asked to consult on the patients because their laboratory findings were inconsistent. "Some of them had a sick euthyroid type of hypothyroidism, where their TSH may be borderline low-normal, with a low T3 or T4, which is why they called us, because they weren’t sure what was going on. In addition, they had symptoms of hypogonadism, low testosterone on labs, and cortisol resistance or increased cortisol because of the stress," he explained.

The endocrinologists’ differential diagnosis consisted of anorexia, depression, and malingering. Detailed histories revealed that the patients had a weight loss of up to 113 pounds over the past few months; therefore, they had severe protein and caloric malnourishment. They also reported depression, not eating, and exercising a lot; one said he had been using a fat-reducing agent.

Dr. Skolnick disclosed no relevant conflicts of interest.

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Insulin Perturbations Seen in Nondiabetic Patients With NAFLD

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LAS VEGAS – Nondiabetic patients with nonalcoholic fatty liver disease already have insulin perturbations putting them on track for a variety of more serious health conditions, new data show.

In a study of 98 consecutive nondiabetic patients with NAFLD referred to a metabolic liver clinic, the mean fasting insulin level was 14.3 microIU/mL, according to data reported at the annual meeting of the American Association of Clinical Endocrinologists.

Additionally, mean insulin levels during an oral glucose tolerance test (OGTT) exceeded the upper limit of normal from 60 minutes after glucose administration onward, with the gap increasing out to 120 minutes.

"Hyperinsulinemia and insulin resistance are already present in patients with NAFLD," commented first author Dr. Leah Folb of Weill Cornell Medical College, Houston Methodist Hospital in Texas. Intervention at this early point might help prevent progression to nonalcoholic steatohepatitis (NASH), diabetes, and cardiovascular disease, she said.

This patient population should be further evaluated, according to Dr. Folb. "Consider OGTT in all patients with persistent abnormal liver function tests if you have ruled out other causes, such as alcoholic [etiology] and hepatitis. And consider NASH FibroSure in all the patients with abnormal liver function tests and/or insulin resistance," she recommended.

The investigators are establishing a registry to follow such patients longitudinally and determine the natural history of insulin resistance. "We want to assess the response to interventions such as pioglitazone [Actos] and vitamin E based on the PIVENS study [Pioglitazone or Vitamin E for NASH Study]," she added.

Session comoderator Dr. Edward S. Horton, vice president and director of clinical research at the Joslin Diabetes Center and professor of medicine at Harvard Medical School, Boston, said the findings were "not surprising," as previous studies, especially by investigators in Finland, have shown that higher liver fat content is associated with insulin resistance.

This new study "adds to our understanding that NAFLD is associated with insulin resistance and metabolic abnormalities," he commented in an interview. "We should be treating, and probably the best way to treat this is by dietary restriction and weight loss and lifestyle modifications."

Explaining the study’s rationale, Dr. Folb noted that the risk of cardiovascular death increases with simple steatosis and increases further still with the more advanced NASH. "We’re thinking that insulin resistance and maybe hyperinsulinemia may be the link here," she said.

On average, the patients studied had a body mass index of 30 kg/m2, triglyceride level of 149 mg/dL, and HDL cholesterol level of 47 mg/dL. Results of NASH FibroSure testing showed that their mean fibroscore was 0.25 and their mean steatosis score was 0.60.

Fully 40% of the patients overall (48% of women and 28% of men) had prediabetes, Dr. Folb reported.

Analyses showed positive correlations of steatosis score with BMI (P less than .0001); of steatosis score with hemoglobin A1c (P = .003); of beta-cell function, as ascertained from HOMA-B, with BMI (P = .01); and of insulin resistance, as ascertained from HOMA-IR, with BMI (P = .02).

Dr. Folb disclosed no relevant conflicts of interest.

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LAS VEGAS – Nondiabetic patients with nonalcoholic fatty liver disease already have insulin perturbations putting them on track for a variety of more serious health conditions, new data show.

In a study of 98 consecutive nondiabetic patients with NAFLD referred to a metabolic liver clinic, the mean fasting insulin level was 14.3 microIU/mL, according to data reported at the annual meeting of the American Association of Clinical Endocrinologists.

Additionally, mean insulin levels during an oral glucose tolerance test (OGTT) exceeded the upper limit of normal from 60 minutes after glucose administration onward, with the gap increasing out to 120 minutes.

"Hyperinsulinemia and insulin resistance are already present in patients with NAFLD," commented first author Dr. Leah Folb of Weill Cornell Medical College, Houston Methodist Hospital in Texas. Intervention at this early point might help prevent progression to nonalcoholic steatohepatitis (NASH), diabetes, and cardiovascular disease, she said.

This patient population should be further evaluated, according to Dr. Folb. "Consider OGTT in all patients with persistent abnormal liver function tests if you have ruled out other causes, such as alcoholic [etiology] and hepatitis. And consider NASH FibroSure in all the patients with abnormal liver function tests and/or insulin resistance," she recommended.

The investigators are establishing a registry to follow such patients longitudinally and determine the natural history of insulin resistance. "We want to assess the response to interventions such as pioglitazone [Actos] and vitamin E based on the PIVENS study [Pioglitazone or Vitamin E for NASH Study]," she added.

Session comoderator Dr. Edward S. Horton, vice president and director of clinical research at the Joslin Diabetes Center and professor of medicine at Harvard Medical School, Boston, said the findings were "not surprising," as previous studies, especially by investigators in Finland, have shown that higher liver fat content is associated with insulin resistance.

This new study "adds to our understanding that NAFLD is associated with insulin resistance and metabolic abnormalities," he commented in an interview. "We should be treating, and probably the best way to treat this is by dietary restriction and weight loss and lifestyle modifications."

Explaining the study’s rationale, Dr. Folb noted that the risk of cardiovascular death increases with simple steatosis and increases further still with the more advanced NASH. "We’re thinking that insulin resistance and maybe hyperinsulinemia may be the link here," she said.

On average, the patients studied had a body mass index of 30 kg/m2, triglyceride level of 149 mg/dL, and HDL cholesterol level of 47 mg/dL. Results of NASH FibroSure testing showed that their mean fibroscore was 0.25 and their mean steatosis score was 0.60.

Fully 40% of the patients overall (48% of women and 28% of men) had prediabetes, Dr. Folb reported.

Analyses showed positive correlations of steatosis score with BMI (P less than .0001); of steatosis score with hemoglobin A1c (P = .003); of beta-cell function, as ascertained from HOMA-B, with BMI (P = .01); and of insulin resistance, as ascertained from HOMA-IR, with BMI (P = .02).

Dr. Folb disclosed no relevant conflicts of interest.

LAS VEGAS – Nondiabetic patients with nonalcoholic fatty liver disease already have insulin perturbations putting them on track for a variety of more serious health conditions, new data show.

In a study of 98 consecutive nondiabetic patients with NAFLD referred to a metabolic liver clinic, the mean fasting insulin level was 14.3 microIU/mL, according to data reported at the annual meeting of the American Association of Clinical Endocrinologists.

Additionally, mean insulin levels during an oral glucose tolerance test (OGTT) exceeded the upper limit of normal from 60 minutes after glucose administration onward, with the gap increasing out to 120 minutes.

"Hyperinsulinemia and insulin resistance are already present in patients with NAFLD," commented first author Dr. Leah Folb of Weill Cornell Medical College, Houston Methodist Hospital in Texas. Intervention at this early point might help prevent progression to nonalcoholic steatohepatitis (NASH), diabetes, and cardiovascular disease, she said.

This patient population should be further evaluated, according to Dr. Folb. "Consider OGTT in all patients with persistent abnormal liver function tests if you have ruled out other causes, such as alcoholic [etiology] and hepatitis. And consider NASH FibroSure in all the patients with abnormal liver function tests and/or insulin resistance," she recommended.

The investigators are establishing a registry to follow such patients longitudinally and determine the natural history of insulin resistance. "We want to assess the response to interventions such as pioglitazone [Actos] and vitamin E based on the PIVENS study [Pioglitazone or Vitamin E for NASH Study]," she added.

Session comoderator Dr. Edward S. Horton, vice president and director of clinical research at the Joslin Diabetes Center and professor of medicine at Harvard Medical School, Boston, said the findings were "not surprising," as previous studies, especially by investigators in Finland, have shown that higher liver fat content is associated with insulin resistance.

This new study "adds to our understanding that NAFLD is associated with insulin resistance and metabolic abnormalities," he commented in an interview. "We should be treating, and probably the best way to treat this is by dietary restriction and weight loss and lifestyle modifications."

Explaining the study’s rationale, Dr. Folb noted that the risk of cardiovascular death increases with simple steatosis and increases further still with the more advanced NASH. "We’re thinking that insulin resistance and maybe hyperinsulinemia may be the link here," she said.

On average, the patients studied had a body mass index of 30 kg/m2, triglyceride level of 149 mg/dL, and HDL cholesterol level of 47 mg/dL. Results of NASH FibroSure testing showed that their mean fibroscore was 0.25 and their mean steatosis score was 0.60.

Fully 40% of the patients overall (48% of women and 28% of men) had prediabetes, Dr. Folb reported.

Analyses showed positive correlations of steatosis score with BMI (P less than .0001); of steatosis score with hemoglobin A1c (P = .003); of beta-cell function, as ascertained from HOMA-B, with BMI (P = .01); and of insulin resistance, as ascertained from HOMA-IR, with BMI (P = .02).

Dr. Folb disclosed no relevant conflicts of interest.

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Insulin perturbations seen in nondiabetic patients with NAFLD

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Display Headline
Insulin perturbations seen in nondiabetic patients with NAFLD

LAS VEGAS – Nondiabetic patients with nonalcoholic fatty liver disease already have insulin perturbations putting them on track for a variety of more serious health conditions, new data show.

In a study of 98 consecutive nondiabetic patients with NAFLD referred to a metabolic liver clinic, the mean fasting insulin level was 14.3 microIU/mL, according to data reported May 16 at the annual meeting of the American Association of Clinical Endocrinologists.

Additionally, mean insulin levels during an oral glucose tolerance test (OGTT) exceeded the upper limit of normal from 60 minutes after glucose administration onward, with the gap increasing out to 120 minutes.

"Hyperinsulinemia and insulin resistance are already present in patients with NAFLD," commented first author Dr. Leah Folb of Weill Cornell Medical College, Houston Methodist Hospital in Texas. Intervention at this early point might help prevent progression to nonalcoholic steatohepatitis (NASH), diabetes, and cardiovascular disease, she said.

This patient population should be further evaluated, according to Dr. Folb. "Consider OGTT in all patients with persistent abnormal liver function tests if you have ruled out other causes, such as alcoholic [etiology] and hepatitis. And consider NASH FibroSure in all the patients with abnormal liver function tests and/or insulin resistance," she recommended.

The investigators are establishing a registry to follow such patients longitudinally and determine the natural history of insulin resistance. "We want to assess the response to interventions such as pioglitazone [Actos] and vitamin E based on the PIVENS study [Pioglitazone or Vitamin E for NASH Study]," she added.

Session comoderator Dr. Edward S. Horton, vice president and director of clinical research at the Joslin Diabetes Center and professor of medicine at Harvard Medical School, Boston, said the findings were "not surprising," as previous studies, especially by investigators in Finland, have shown that higher liver fat content is associated with insulin resistance.

This new study "adds to our understanding that NAFLD is associated with insulin resistance and metabolic abnormalities," he commented in an interview. "We should be treating, and probably the best way to treat this is by dietary restriction and weight loss and lifestyle modifications."

Explaining the study’s rationale, Dr. Folb noted that the risk of cardiovascular death increases with simple steatosis and increases further still with the more advanced NASH. "We’re thinking that insulin resistance and maybe hyperinsulinemia may be the link here," she said.

On average, the patients studied had a body mass index of 30 kg/m2, triglyceride level of 149 mg/dL, and HDL cholesterol level of 47 mg/dL. Results of NASH FibroSure testing showed that their mean fibroscore was 0.25 and their mean steatosis score was 0.60.

Fully 40% of the patients overall (48% of women and 28% of men) had prediabetes, Dr. Folb reported.

Analyses showed positive correlations of steatosis score with BMI (P less than .0001); of steatosis score with hemoglobin A1c (P = .003); of beta-cell function, as ascertained from HOMA-B, with BMI (P = .01); and of insulin resistance, as ascertained from HOMA-IR, with BMI (P = .02).

Dr. Folb disclosed no relevant conflicts of interest.

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LAS VEGAS – Nondiabetic patients with nonalcoholic fatty liver disease already have insulin perturbations putting them on track for a variety of more serious health conditions, new data show.

In a study of 98 consecutive nondiabetic patients with NAFLD referred to a metabolic liver clinic, the mean fasting insulin level was 14.3 microIU/mL, according to data reported May 16 at the annual meeting of the American Association of Clinical Endocrinologists.

Additionally, mean insulin levels during an oral glucose tolerance test (OGTT) exceeded the upper limit of normal from 60 minutes after glucose administration onward, with the gap increasing out to 120 minutes.

"Hyperinsulinemia and insulin resistance are already present in patients with NAFLD," commented first author Dr. Leah Folb of Weill Cornell Medical College, Houston Methodist Hospital in Texas. Intervention at this early point might help prevent progression to nonalcoholic steatohepatitis (NASH), diabetes, and cardiovascular disease, she said.

This patient population should be further evaluated, according to Dr. Folb. "Consider OGTT in all patients with persistent abnormal liver function tests if you have ruled out other causes, such as alcoholic [etiology] and hepatitis. And consider NASH FibroSure in all the patients with abnormal liver function tests and/or insulin resistance," she recommended.

The investigators are establishing a registry to follow such patients longitudinally and determine the natural history of insulin resistance. "We want to assess the response to interventions such as pioglitazone [Actos] and vitamin E based on the PIVENS study [Pioglitazone or Vitamin E for NASH Study]," she added.

Session comoderator Dr. Edward S. Horton, vice president and director of clinical research at the Joslin Diabetes Center and professor of medicine at Harvard Medical School, Boston, said the findings were "not surprising," as previous studies, especially by investigators in Finland, have shown that higher liver fat content is associated with insulin resistance.

This new study "adds to our understanding that NAFLD is associated with insulin resistance and metabolic abnormalities," he commented in an interview. "We should be treating, and probably the best way to treat this is by dietary restriction and weight loss and lifestyle modifications."

Explaining the study’s rationale, Dr. Folb noted that the risk of cardiovascular death increases with simple steatosis and increases further still with the more advanced NASH. "We’re thinking that insulin resistance and maybe hyperinsulinemia may be the link here," she said.

On average, the patients studied had a body mass index of 30 kg/m2, triglyceride level of 149 mg/dL, and HDL cholesterol level of 47 mg/dL. Results of NASH FibroSure testing showed that their mean fibroscore was 0.25 and their mean steatosis score was 0.60.

Fully 40% of the patients overall (48% of women and 28% of men) had prediabetes, Dr. Folb reported.

Analyses showed positive correlations of steatosis score with BMI (P less than .0001); of steatosis score with hemoglobin A1c (P = .003); of beta-cell function, as ascertained from HOMA-B, with BMI (P = .01); and of insulin resistance, as ascertained from HOMA-IR, with BMI (P = .02).

Dr. Folb disclosed no relevant conflicts of interest.

LAS VEGAS – Nondiabetic patients with nonalcoholic fatty liver disease already have insulin perturbations putting them on track for a variety of more serious health conditions, new data show.

In a study of 98 consecutive nondiabetic patients with NAFLD referred to a metabolic liver clinic, the mean fasting insulin level was 14.3 microIU/mL, according to data reported May 16 at the annual meeting of the American Association of Clinical Endocrinologists.

Additionally, mean insulin levels during an oral glucose tolerance test (OGTT) exceeded the upper limit of normal from 60 minutes after glucose administration onward, with the gap increasing out to 120 minutes.

"Hyperinsulinemia and insulin resistance are already present in patients with NAFLD," commented first author Dr. Leah Folb of Weill Cornell Medical College, Houston Methodist Hospital in Texas. Intervention at this early point might help prevent progression to nonalcoholic steatohepatitis (NASH), diabetes, and cardiovascular disease, she said.

This patient population should be further evaluated, according to Dr. Folb. "Consider OGTT in all patients with persistent abnormal liver function tests if you have ruled out other causes, such as alcoholic [etiology] and hepatitis. And consider NASH FibroSure in all the patients with abnormal liver function tests and/or insulin resistance," she recommended.

The investigators are establishing a registry to follow such patients longitudinally and determine the natural history of insulin resistance. "We want to assess the response to interventions such as pioglitazone [Actos] and vitamin E based on the PIVENS study [Pioglitazone or Vitamin E for NASH Study]," she added.

Session comoderator Dr. Edward S. Horton, vice president and director of clinical research at the Joslin Diabetes Center and professor of medicine at Harvard Medical School, Boston, said the findings were "not surprising," as previous studies, especially by investigators in Finland, have shown that higher liver fat content is associated with insulin resistance.

This new study "adds to our understanding that NAFLD is associated with insulin resistance and metabolic abnormalities," he commented in an interview. "We should be treating, and probably the best way to treat this is by dietary restriction and weight loss and lifestyle modifications."

Explaining the study’s rationale, Dr. Folb noted that the risk of cardiovascular death increases with simple steatosis and increases further still with the more advanced NASH. "We’re thinking that insulin resistance and maybe hyperinsulinemia may be the link here," she said.

On average, the patients studied had a body mass index of 30 kg/m2, triglyceride level of 149 mg/dL, and HDL cholesterol level of 47 mg/dL. Results of NASH FibroSure testing showed that their mean fibroscore was 0.25 and their mean steatosis score was 0.60.

Fully 40% of the patients overall (48% of women and 28% of men) had prediabetes, Dr. Folb reported.

Analyses showed positive correlations of steatosis score with BMI (P less than .0001); of steatosis score with hemoglobin A1c (P = .003); of beta-cell function, as ascertained from HOMA-B, with BMI (P = .01); and of insulin resistance, as ascertained from HOMA-IR, with BMI (P = .02).

Dr. Folb disclosed no relevant conflicts of interest.

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Insulin perturbations seen in nondiabetic patients with NAFLD
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Insulin perturbations seen in nondiabetic patients with NAFLD
Legacy Keywords
Nondiabetic patients, nonalcoholic fatty liver disease, insulin perturbations, serious health conditions, NAFLD, metabolic liver clinic, mean fasting insulin level, American Association of Clinical Endocrinologists, oral glucose tolerance test, OGTT,
Hyperinsulinemia, insulin resistance, Dr. Leah Folb,
Legacy Keywords
Nondiabetic patients, nonalcoholic fatty liver disease, insulin perturbations, serious health conditions, NAFLD, metabolic liver clinic, mean fasting insulin level, American Association of Clinical Endocrinologists, oral glucose tolerance test, OGTT,
Hyperinsulinemia, insulin resistance, Dr. Leah Folb,
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Major finding: The mean fasting insulin level was 14.3 microIU/mL, and mean insulin levels on an OGTT exceeded the upper limit of normal from 60 to 120 minutes after glucose challenge.

Data source: A cohort study of 98 consecutive nondiabetic patients with NAFLD.

Disclosures: Dr. Folb disclosed no relevant conflicts of interest.