Alliance of Randomized Trials of Medicine vs Metabolic Surgery in Type 2 Diabetes (ARMMS-T2D)

Ali Aminian

Status

Invitation-only

Conditions

Type 2 Diabetes Mellitus

Obesity

Treatments

Procedure: Bariatric surgery involving Laparoscopic sleeve gastrectomy

Procedure: Bariatric surgery involving Laparoscopic adjustable gastric banding

Procedure: Bariatric surgery involving Roux-en-Y gastric bypass

Study type

Observational

Funder types

Other

NIH

Identifiers

NCT02328599

COV EES-14606

U01DK114156 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

The four investigative groups initiated their individual RCT's at their respective sites to evaluate the effectiveness of bariatric surgery compared to multidisciplinary medical and lifestyle management of diabetes and body weight. The original trials were each designed to assess feasibility over a relatively short duration of follow-up (1-3 years). Individually, each trial lacked the sample size and duration of follow-up to meaningfully inform clinical decision making. Together, with the funding provided by the NIH for longer follow-up, the Consortium trial can provide a unique national resource to address timely and unanswered clinical questions related to the durability of these alternative management approaches in patients with T2D and obesity. Together, participants from these studies represent the largest cohort with diabetes (one third having a BMI <35 kg/m2) ever to undergo randomized assignment to bariatric surgical procedure vs. medical/lifestyle intervention.

Enrollment

302 estimated patients

Sex

All

Ages

20 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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).

Exclusion criteria

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