GI Dynamics, a leader in non-surgical, endoscopic treatments for type 2 diabetes and obesity, announced today new results from three studies that demonstrate the positive effects of the EndoBarrier® Gastrointestinal Liner on type 2 diabetes, weight loss and other metabolic factors. These data support the use of EndoBarrier as a primary therapy for the treatment of type 2 diabetes and obesity in patients with a body mass index (BMI) greater than 30 who have been unable to control their diabetes or lose weight through lifestyle changes and medications. Importantly, results from one study reveal for the first time the hormonal activity of EndoBarrier, which results in improved glycemic control and weight loss. These data and the benefits and role of EndoBarrier in type 2 diabetes were discussed during the session, "Novel Experimental Approaches for Diabetes/Obesity," during the 2nd World Congress on Interventional Therapies for Type 2 Diabetes in New York.
Beneficial Hormonal Effects Result in Rapid and Long-lasting Improvement in Diabetes
Results were presented on the effects of EndoBarrier on two gastrointestinal hormones, gut peptides glucagon-like peptide-1 (GLP-1) and peptide YY (PYY), and other diabetes measures. The study, led by Professor Jan Willem Greve, M.D., Ph.D., Gastrointestinal and Bariatric Surgery, Atrium Medical Center, Parkstad Heerlen, The Netherlands, found that EndoBarrier treatment offered rapid and long-lasting improvement in diabetes, and for the first time, demonstrated beneficial hormonal effects similar to surgical interventions such as Roux-en-Y gastric bypass.
In the study, 17 obese patients with type 2 diabetes were implanted with the EndoBarrier for 24 weeks. Each patient was evaluated to assess levels of HbA1c, glucose, insulin, GLP-1 and PYY prior to, and at 24 weeks after implantation through blood draws conducted during meal tolerance tests using a 500 kcal test meal.
EndoBarrier treatment resulted in:
- Rapid increase and sustained insulin sensitivity;
- Increased levels of both PYY and GLP-1 after one-week implantation;
- Mean excess weight loss of 29.8% and significant improvement in HbA1c of 1.4% (from 8.4% at baseline to 7.0%) in patients following six months of EndoBarrier use;
- Reduction of anti-diabetic medications in 16/17 participants.
"These data reveal that EndoBarrier treatment affects key hormones involved in insulin sensitivity and satiety, which is likely the cause for the rapid improvement seen in type 2 diabetes," said Dr. Greve. "This supports the belief that the EndoBarrier works by affecting hormone activation and that the device is a promising tool for the treatment of type 2 diabetes in obese individuals."
Lee M. Kaplan, M.D., Ph.D., associate professor of medicine, Harvard Medical School; director, MGH Weight Center, Massachusetts General Hospital, Boston; and part of a panel discussion on novel approaches to diabetes and obesity at the 2nd World Congress, commented, "The findings from this study are striking. The EndoBarrier appears to affect the metabolic functions involved in type 2 diabetes through mechanisms similar to those that make bariatric surgery such an effective therapy for diabetes and obesity."
Key Findings Support Role of EndoBarrier as Primary Therapy for Type 2 Diabetes and Obesity
Data from two clinical trials reported at the meeting indicate that the EndoBarrier may be a candidate for the primary therapy of type 2 diabetes and obesity. In one study, E.G.H.D. Moura, M.D., Ph.D., director of endoscopy, Hospital das Clinicas, University of São Paulo, evaluated use of the EndoBarrier in 22 patients with type 2 diabetes for one year.
After 12 months of EndoBarrier treatment, patients experienced:
- Reduction in HbA1c levels from 8.9% at baseline to 6.6% (p<0.0001);
- Decreased glucose levels from 175.6 at baseline to 137.8 mg/dL (p<0.0001);
- Absolute weight loss of 20.2 kg (44 lbs.; p<0.0001), or 39% excess weight loss (p<0.0001).
Importantly, metabolic functions including levels of insulin, cholesterol, LDL and triglycerides were normalized at one year.
In another study, Alex Escalona, M.D., Department of Digestive Surgery, Pontificia Universidad Católica de Chile, Santiago, Chile, evaluated the effects of the EndoBarrier on weight loss and other cardiometabolic factors in 46 obese patients. At 12 months, the EndoBarrier treatment induced 20.0% total body weight loss (observed weight loss of 22.8 kg/50 lbs.), or 46.4% excess weight loss (p<0.0001).
The study also demonstrated that the EndoBarrier treatment improved key cardiometabolic risk factors, including:
- Reduction in total cholesterol levels (195.0 mg/dL at baseline to 159.0 mg/dL; p<0.001);
- Reduction in diastolic blood pressure (85 mmHg at baseline to 71 mmHg; p<0.001).
Data from a subset of six patients with type 2 diabetes achieved a mean reduction in HbA1c of 1.4>
Pharmaceutical treatments for type 2 diabetes often have diminishing benefits for patients despite more aggressive therapy. Surgical interventions, while effective, are associated with patient concerns about the risks of surgery and the irreversible aspects of some procedures. The EndoBarrier is a non-surgical, removable, physical barrier that enables food to bypass portions of the intestine, mimicking existing surgical interventions. This mechanism results in changes that "reset" the body's metabolic functions to a more normalized state.
"There is a need for a type 2 diabetes and obesity therapy that provides effective, long-term results. Pharmaceutical regimens often cause weight gain in diabetes patients over time, while surgical interventions to obesity carry risks and complications that often concern patients," said Dr. Escalona. "The EndoBarrier presents a unique solution to fill this treatment gap for type 2 diabetes and obesity. It has clinically proven rapid and long-lasting improvements in blood sugar control and weight loss, and offers physicians and patients an effective, non-surgical solution for the treatment of these diseases."
Restoring insulin sensitivity without TZD side effects