Alliance of Randomized Trials of Medicine vs Metabolic Surgery in Type 2 Diabetes

Completed

Conditions studied: Type 2 Diabetes Mellitus, Obesity

In brief

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.

Key facts

Study ID

NCT02328599

Run by

Ali Aminian

People needed

262

Starts

2018-04-10

Expected to finish

2024-02-27

Last updated by the study team

2026-03-31

Who can join

Age: 20 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Original inclusion criteria for participation in the RCTs at all sites included:
• Candidate for general anesthesia or unsupervised exercise.
• Age ≥20 and ≤65 years.
• Body mass index >27 and ≤45 kg/m2.
• Diagnosis of type 2 diabetes confirmed by either requiring diabetes medication and/or having elevated glycemia based on HbA1c, fasting plasma glucose, and/or oral glucose tolerance test (OGTT) results, according to American Diabetes Association criteria.
• Ability and willingness to participate in the study and agree to any of the research arms.
• Able to understand the options and to comply with the requirements of each program.
• Negative urine pregnancy test at screening and baseline visits (prior to surgery) for women of childbearing potential (i.e., biologically capable of becoming pregnant).

You may not qualify if…

• Subjects who were randomized in one of the four RCTs but never initiated intervention / did not receive randomized treatment
• Refusal to sign informed consent

Where it is running

• Joslin Diabetes Center — Boston, Massachusetts, United States
• Cleveland Clinic Digestive Disease Institute — Cleveland, Ohio, United States
• University of Pittsburg Medical Center — Pittsburgh, Pennsylvania, United States
• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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