This study is investigating the safety and effectiveness of the EndoBarrier system for patients with poorly controlled type 2 diabetes (T2D) and obesity. The main outcome to be measured will be the change in blood glucose levels. This trial is recruiting in multiple locations across the United States.
The details
Bariatric surgery is the most common treatment option for obese patients with T2D. This procedure can help improve diabetes symptoms and promote weight loss. However, not all patients are good candidates for surgery. The EndoBarrier system is another option for these patients. This is a medical device implanted via endoscopy, so it does not require invasive surgery.
This study is evaluating the safety and effectiveness of the EndoBarrier in patients with poorly controlled T2D and obesity. The main outcome to be measured will be the change in HbA1c (average blood glucose levels over the past 3 months) up to 1 year.
Who are they looking for?
This study is looking for 240 participants with T2D for at least 15 years. Patients must have a body mass index (BMI; a weight measurement in relation to height) between 30 and 50 kg/m2 and must agree to use contraception to participate in this study. Patients should have tried at least 3 non-insulin medications and failed to achieve blood glucose levels below 7%.
Patients who had stomach or bowel surgery before that could affect the EndoBarrier cannot participate. Patients with liver disease, pancreatitis, osteoporosis, or Crohn’s disease cannot participate. Patients who are allergic to antibiotics like penicillin cannot participate. Patients taking over-the-counter medications like aspirin or ibuprofen within a month of the study cannot participate.
How will it work
This study will have two groups of patients. Both groups of patients will receive an upper endoscopy to look at the esophagus, stomach, and first part of the small intestine. Only one group of patients will receive the EndoBarrier. This is a thin, flexible tube that takes ingested food directly from the first part of the small intestine to the end of the small intestine. Ingested food avoids contact with the intestinal wall, so fewer calories are absorbed. This can help promote weight loss. The second group will not receive the EndoBarrier through endoscopy.
The main outcome to be measured will be the change in HbA1c levels from the start of treatment up to 1 year. The number of patients who lose at least 5% of their body weight after treatment will also be measured. Changes in cholesterol levels, blood pressure, and the number of patients who start using insulin therapy will also be measured. Patients will be followed-up for up to 2 years.
