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New research

EndoBarrier helps diabetes factors in the overweight

GI Dynamics' EndoBarrier attempts to replicate intestinal bypass component of a RYGB.
61.5% of patients demonstrated HbA1c under 7% after 12 months
Fasting plasma glucose dropped an average of 44.1±20.7mg/dl over a year
Data presented at ASMBS’ 29th annual meeting

The EndoBarrier duodenal-jejunal bypass liner leads to “substantial” metabolic improvement in overweight and mildly obese type 2 diabetes patients, according to new data presented at the ASMBS’ 29th annual meeting.

In the study, ‘Metabolic Improvements in Type 2 Diabetes in Subjects Without Severe Obesity With the Endoscopic Duodenal-Jejunal Bypass Liner’, saw the diabetic factors HbA1c, fasting plasma glucose, and low-density lipoprotein, drop after 12 months.  

Three months after implant, 12 out of 19 patients (63.2%) exhibited HbA1c levels under 7.0%, the level at which diabetes is considered to be controlled. Eight out of 13 patients (61.5%) demonstrated HbA1c under 7% after 12 months.

The Endobarrier’s inventors, GI Dynamics, are marketing the device as a potential cure for diabetes as well as for obesity.

“Our data point to a substantial improvement in glycemic control and other metabolic parameters even among overweight – but not severely obese – diabetic patients during EndoBarrier Therapy,” remarked study lead author Dr Ricardo V. Cohen, from the Center for the Surgical Treatment of Morbid Obesity and Metabolic Disorders, Hospital Alemão Oswaldo Cruz, São Paulo, Brazil.

“These are promising data and suggest that EndoBarrier may play a valuable role for overweight patients struggling to control their diabetes and lose weight.”

Method and results

23 patients overweight and mildly obese patients (BMI 23-36) were enrolled for the study, all of whom had type 2 diabetes being treated with oral agents alone. 20 of the 23 subjects were successfully endoscopically implanted with the liner; three could not due to unfavourable anatomy.

Over the 12 months of the study, there were four early endoscopic removals: twice because of device movement, once because of abdominal pain, and once after principal investigator request.

Follow-up included monthly determinations of HbA1c, fasting plasma glucose, lipids, and percentage total body weight loss.

At the start of the study, patient baseline HbA1c was 8.7±0.20%, fasting plasma glucose was at 197.5±16.8mg/dl, low-density lipoprotein was at 137.8±13.1mg/dl, triglycerides were at 226.1±35.5mg/dl, and average BMI was 30.2±0.83.

The device remained in place for one year in 13 out of 17 patients (76.4%); three patients kept their devices in place after the endpoint of the study.

At one year, the patients’ HbA1c had decreased by 1.3±0.37%, fasting plasma glucose had dropped by 44.1±20.7mg/dl, low-density lipids had decreased by 25.6±7.0mg/dl, and triglycerides by 42.5±17.3mg/dl.

The patients’ total body weight loss dropped by 8.4±1.7%.

Patients in the study were men and women between 18 and 55 years who had type 2 diabetes for ten years or less and were on oral diabetic medications. Their initial HbA1c levels were between 7.5 and 10%.

EndoBarrier

The EndoBarrier is an attempt to mimic the effect of the intestinal bypass component of the Roux-en-Y gastric bypass.

The device has already been tested in a study by Escalona et al which examined the benefits of the device in morbidly obese patients, in terms of weight loss and metabolic function.

The study found that patients underwent significant weight loss and improvements in cardiometabolic risk factors after one year.

EndoBarrier received CE Mark approval for Europe in 2010 as well as approval by the Therapeutic Goods Administration in Australia in 2011 for the treatment of type 2 diabetes and/or obesity. EndoBarrier is currently commercially available in some European markets, as well as Chile and Australia.

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