At a glance
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A Prospective Consortium Evaluating the Long-term Follow-up of Patients With Type 2 Diabetes Enrolled In a Randomized Controlled Trial Comparing Bariatric Surgery Versus Medical Management
In Brief
An observational study evaluating Bariatric surgery involving Roux-en-Y gastric bypass, Bariatric surgery involving Laparoscopic adjustable gastric banding, and 1 other intervention for Type 2 Diabetes Mellitus and Obesity. Completed, enrolled 262 participants across 4 sites.
Detailed Summary
Initially, 4 teams of investigators conducted randomized controlled trials (RCT) at their own site to evaluate the effectiveness of bariatric surgery compared to medical/lifestyle management of type 2 diabetes. Each study followed subjects for a duration of about 1 - 3 years. Following this, a consortium was created to pool data and continue to follow study participants. This early collaboration of the 4 groups of investigators was supported by Industry sponsors (Ethicon, Inc and Medtronic-MITG). Now, the investigators have successfully received a grant from the NIH, as the sole supporter of continued observational follow-up of study participants. The continuing aim of this study is to combine data from the 4 studies and follow the original randomized subjects for an additional 5 years of follow-up. The purpose of the study is to determine the longer term durability and effectiveness of bariatric surgery compared to medical/lifestyle intervention on the treatment of type 2 diabetes.
Study Details
Timeline
Interventions
Subjects previously underwent Bariatric surgery involving Roux-en-Y gastric bypass (RYGB) surgery at one of the 4 participating sites and will be followed prospectively.
Subjects previously underwent Bariatric surgery involving laparoscopic adjustable gastric banding (LAGB) surgery at one of the 4 participating sites and will be followed prospectively.
Subjects previously underwent Bariatric surgery involving laparoscopic sleeve gastrectomy (LSG) surgery at one of the 4 participating sites and will be followed prospectively.