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

NCT ID: NCT02328599

Last Updated: 2025-01-17

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 302 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-04-10
• Study Completion Date: 2031-06-30

Brief 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.

Detailed 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.

Conditions

Type 2 Diabetes Mellitus; Obesity

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Surgical

Prior Bariatric surgery

Bariatric surgery involving Roux-en-Y gastric bypass

Intervention Type: PROCEDURE

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.

Bariatric surgery involving Laparoscopic adjustable gastric banding

Intervention Type: PROCEDURE

Subjects previously underwent Bariatric surgery involving laparoscopic adjustable gastric banding (LAGB) surgery at one of the 4 participating sites and will be followed prospectively.

Bariatric surgery involving Laparoscopic sleeve gastrectomy

Intervention Type: PROCEDURE

Subjects previously underwent Bariatric surgery involving laparoscopic sleeve gastrectomy (LSG) surgery at one of the 4 participating sites and will be followed prospectively.

Non-surgical

Medical / Lifestyle management

No interventions assigned to this group

Interventions

Bariatric surgery involving Roux-en-Y gastric bypass

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.

Intervention Type: PROCEDURE

Bariatric surgery involving Laparoscopic adjustable gastric banding

Subjects previously underwent Bariatric surgery involving laparoscopic adjustable gastric banding (LAGB) surgery at one of the 4 participating sites and will be followed prospectively.

Intervention Type: PROCEDURE

Bariatric surgery involving Laparoscopic sleeve gastrectomy

Subjects previously underwent Bariatric surgery involving laparoscopic sleeve gastrectomy (LSG) surgery at one of the 4 participating sites and will be followed prospectively.

Intervention Type: PROCEDURE

Other Intervention Names

RYGB; LAGB; LSG

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

The Cleveland Clinic

OTHER

Sponsor Role: collaborator

Ali Aminian

OTHER

Sponsor Role: lead

Responsible Party

Ali Aminian

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Aminian Ali, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

John Kirwan, PhD

Role: PRINCIPAL_INVESTIGATOR

Pennington Biomedical Research Center

Locations

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

Countries

United States

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Other Identifiers

U01DK114156

Identifier Type: NIH

Identifier Source: secondary_id

View Link

COV EES-14606

Identifier Type: -

Identifier Source: org_study_id