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

Sponsor
The Cleveland Clinic (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT02328599
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
302
Enrollment
4
Locations
73.7
Anticipated Duration (Months)
75.5
Patients Per Site
1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Bariatric surgery involving Roux-en-Y gastric bypass
  • Procedure: Bariatric surgery involving Laparoscopic adjustable gastric banding
  • Procedure: Bariatric surgery involving Laparoscopic sleeve gastrectomy

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 Design

Study Type:
Observational
Anticipated Enrollment :
302 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
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
Actual Study Start Date :
Apr 10, 2018
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm 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

    Outcome Measures

    Primary Outcome Measures

    1. Change in HbA1c [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

    Secondary Outcome Measures

    1. HbA1c < 6.5% [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

    Other Outcome Measures

    1. HbA1c >6.5% [7-13 years]

      relapse in diabetes control requiring the addition of anti-diabetic medications

    2. change in body weight measured in BMI [7 years and up to 13 years for earliest enrollees]

      Change in body weight status from baseline

    3. change in fasting glucose [7 years and up to 13 years for earliest enrollees]

      Change in diabetes related outcomes including cardiovascular risk factors

    4. change in cholesterol levels [7 years and up to 13 years for earliest enrollees]

      Change in diabetes related outcomes including cardiovascular risk factors

    5. change in blood pressure [7 years and up to 13 years for earliest enrollees]

      Change in diabetes related outcomes including cardiovascular risk factors

    6. change in albuminuria [7 years and up to 13 years for earliest enrollees]

      Change in diabetes related outcomes including cardiovascular risk factors

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Joslin Diabetes Center Boston Massachusetts United States 02215
    2 Cleveland Clinic Bariatric and Metabolic Institute Cleveland Ohio United States 44195
    3 University of Pittsburg Medical Center Pittsburgh Pennsylvania United States 15213
    4 University of Washington Seattle Washington United States 98108

    Sponsors and Collaborators

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

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Sangeeta Kashyap, Co-Principal Investigator, The Cleveland Clinic
    ClinicalTrials.gov Identifier:
    NCT02328599
    Other Study ID Numbers:
    • COV EES-14606
    • U01DK114156
    First Posted:
    Dec 31, 2014
    Last Update Posted:
    Aug 4, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 2

    Study Results

    No Results Posted as of Aug 4, 2022