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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02328599
Recruitment Status : Enrolling by invitation
First Posted : December 31, 2014
Last Update Posted : January 28, 2020
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Sangeeta Kashyap, The Cleveland Clinic

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
Type 2 Diabetes Mellitus Obesity 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.

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Study Type : Observational
Actual 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 : April 10, 2018
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: LSG

Non-surgical
Medical / Lifestyle management



Primary Outcome Measures :
  1. Success rate of biochemical resolution of diabetes [ Time Frame: 7 years ]
    Biochemical resolution of diabetes measured by HbA1c </= 6.5%, without diabetes medications


Secondary Outcome Measures :
  1. Long term diabetes control [ Time Frame: 7 years and each annual visit through the last known follow-up for all patients ]
    Mean and change from baseline in HbA1c


Biospecimen Retention:   Samples Without DNA
Study specific blood and urine specimens will be analyzed at a central laboratory. Participation in the research repository is optional. Blood will be drawn and stored at each site for later analysis.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02328599


Locations
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United States, Massachusetts
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
United States, Ohio
Cleveland Clinic Bariatric and Metabolic Institute
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
University of Pittsburg Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Washington
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
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Principal Investigator: Sangeeta Kashyap, MD The Cleveland Clinic
Principal Investigator: John Kirwan, PhD Pennington Biomedical Research Center
Publications:
CDC. National Diabetes Statistics Report: Estimates of Diabetes and Its Burden in the United States, 2014. US Department of Health and Human Services.

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Responsible Party: Sangeeta Kashyap, Co-Principal Investigator, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT02328599    
Other Study ID Numbers: COV EES-14606
U01DK114156 ( U.S. NIH Grant/Contract )
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: January 28, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases