NCT02328599Completed
Alliance of Randomized Trials of Medicine vs Metabolic Surgery in Type 2 Diabetes
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
Source: ClinicalTrials.gov · Last updated 31 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 262 (actual)
- First submitted
- 23 Dec 2014
- Start date
- 10 Apr 2018
- Primary completion date
- 27 Feb 2024
- Lead sponsor
- Ali Aminian
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT02328599
What you commit to
- Study type: Observational
- Participants enrolled: 262
- From 10 Apr 2018 to the primary completion date, 27 Feb 2024
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Subjects who were randomized in one of the four RCTs but never initiated intervention / did not receive randomized treatment
- Refusal to sign informed consent
Who the study is looking for
- 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).
Age in the registry: 20 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Joslin Diabetes Center Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Cleveland Clinic Digestive Disease Institute Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| University of Pittsburg Medical Center Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| University of Washington Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.