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

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.

Conditions

• Type 2 Diabetes Mellitus
• Obesity

Interventions

PROCEDURE

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.

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.

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.

Sponsors & Collaborators

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

  collaborator NIH

• The Cleveland Clinic

  collaborator OTHER

• Ali Aminian

  lead OTHER

Principal Investigators

• Aminian Ali, MD · The Cleveland Clinic

• John Kirwan, PhD · Pennington Biomedical Research Center

Eligibility

Min Age

20 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-04-10

Primary Completion

2024-02-27

Completion

2024-02-27

Countries

• United States

Study Locations