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

March 27, 2026 updated by: Ali Aminian

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

262

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Joslin Diabetes Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Digestive Disease Institute
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburg Medical Center
    • Washington
      • Seattle, Washington, United States, 98108
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Subjects who were previously enrolled in a Randomized Control Trial (RCT) at one of the four participating sites who initiated one of the intervention procedures - bariatric surgery or medical/lifestyle therapy.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Surgical
Prior Bariatric surgery
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.
Other Names:
  • RYGB
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.
Other Names:
  • LAGB
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.
Other Names:
  • LSG
Non-surgical
Medical / Lifestyle management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c
Time Frame: 7 years and up to 13 years for earliest enrollees
Between group (medical vs. surgical) in HbA1c from baseline to 7 year for all participants and up to 13 years for the earliest enrollees
7 years and up to 13 years for earliest enrollees

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c < 6.5%
Time Frame: 7 years and each annual visit through the last known follow-up for all patients up to 13 years
percent of those achieving diabetes remission without the need for anti-diabetic medications
7 years and each annual visit through the last known follow-up for all patients up to 13 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c >6.5%
Time Frame: 7-13 years
relapse in diabetes control requiring the addition of anti-diabetic medications
7-13 years
change in body weight measured in BMI
Time Frame: 7 years and up to 13 years for earliest enrollees
Change in body weight status from baseline
7 years and up to 13 years for earliest enrollees
change in fasting glucose
Time Frame: 7 years and up to 13 years for earliest enrollees
Change in diabetes related outcomes including cardiovascular risk factors
7 years and up to 13 years for earliest enrollees
change in cholesterol levels
Time Frame: 7 years and up to 13 years for earliest enrollees
Change in diabetes related outcomes including cardiovascular risk factors
7 years and up to 13 years for earliest enrollees
change in blood pressure
Time Frame: 7 years and up to 13 years for earliest enrollees
Change in diabetes related outcomes including cardiovascular risk factors
7 years and up to 13 years for earliest enrollees
change in albuminuria
Time Frame: 7 years and up to 13 years for earliest enrollees
Change in diabetes related outcomes including cardiovascular risk factors
7 years and up to 13 years for earliest enrollees

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ali Aminian

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
The Cleveland Clinic

Investigators

  • Principal Investigator: Aminian Ali, MD, The Cleveland Clinic
  • Principal Investigator: John Kirwan, PhD, Pennington Biomedical Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2018

Primary Completion (Actual)

February 27, 2024

Study Completion (Actual)

February 27, 2024

Study Registration Dates

First Submitted

December 23, 2014

First Submitted That Met QC Criteria

December 23, 2014

First Posted (Estimated)

December 31, 2014

Study Record Updates

Last Update Posted (Actual)

March 31, 2026

Last Update Submitted That Met QC Criteria

March 27, 2026

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COV EES-14606
  • U01DK114156 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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