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

Status:Enrolling by invitation
Conditions:Obesity Weight Loss, Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Age Range:20 - 65
Start Date:April 10, 2018
End Date:June 2022

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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.

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.

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

- Negative urine pregnancy test at screening and baseline visits (prior to surgery)
for women of childbearing potential (i.e., biologically capable of becoming

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
We found this trial at
Seattle, Washington 98104
(206) 543-2100
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
Seattle, WA
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One Joslin Place
Boston, Massachusetts 02215
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Boston, MA
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Cleveland, OH
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Pittsburgh, Pennsylvania 15260
Pittsburgh, PA
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