- Men and women who are 18 years of age and older.
- Individuals who have been diagnosed with diabetes and are obese.
Detailed eligibility reviewed when contacting the study team.
This study is evaluating an alternative treatment for glucose control. The treatment is with a device called the EndoBarrier® System. It is an experimental device that may help to treat diabetes where medications, diet, and exercise alone have not achieved enough improvement.
The EndoBarrier® System is considered investigational which means it is not currently approved by the U.S. Food and Drug Administration (FDA).
Participants will be randomized into one of two treatment groups. Randomization is like flipping a coin and there is a 50/50 chance of being assigned to either group.
The first group will receive the EndoBarrier® System. Participants will undergo a device implantation procedure and must receive a prophylactic dose of antibiotics on the day of both the delivery and retrieval procedures.
The second group will receive a sham procedure, which will consist of the use of general anesthesia and an upper endoscopy without fluoroscopy. This group will not receive the EndoBarrier® System.
Details of the procedures will be explained by the study team after enrollment.
All participants will receive moderate intensity lifestyle and dietary counseling. Participants will also be asked for past medical and surgical history, as well as will be asked to fill out questionnaires, provide blood samples, and undergo scans of their liver.
There are approximately 23 study visits and participants will be compensated for completed study visits.