This trial will study the EndoBarrier System, a tube that goes down the throat and into the stomach, in people with type 2 diabetes and obesity who are not able to control their blood sugar levels with diet and lifestyle changes or medication. The trial will compare the EndoBarrier System plus diet and lifestyle changes to diet and lifestyle changes alone to see if the EndoBarrier System is safe and effective.
To determine if the EndoBarrier System significantly improves glycemic control; to determine if the EndoBarrier System can be safely used to improve glycemic control.
240 patients who will be double-blinded and randomized to two arms of the trial in the ratio of 3 patients (Endobarrier) and 1 patient (Sham)
Primary Treatment: EndoBarrier Liner · Has Placebo Group · N/A
Screening: Screening visits will take 2 hours. During the screening visit, the trial will be reviewed by the study team and patients will be asked to sign a consent form if their questions have been answered and they would like to move forward with participating in the trial. Screening visits include:
Intervention: This is a double-blinded device study. Patients will be randomized on the day of the procedure and will undergo an endoscopy. Patients will not know which group they have been randomized to until the one year mark.
Follow-Up: Patients will be followed for a total of 2 years for this study. Follow-ups occur monthly for the first year and quarterly for the second year. Each study visit includes:
The sponsor will compensate patients $50 per visit, up to $1,150 for the duration of the study if all visits are completed, to cover the cost of travel and parking.
Age 30 - 65 · All Participants · 10 Total Inclusion CriteriaMark “Yes” if the following statements are true for you:
|18 - 65||100.0%|
|Michigan Medicine, Division of Gastroenterology and Hepatology||20.0%|
|Baylor College of Medicine||60.0%|
|MedStar Health Research Institute||20.0%|
|Did not meet criteria||25.0%|