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| Sponsor: | Joslin Diabetes Center |
|---|---|
| Collaborator: |
Brigham and Women's Hospital |
| Information provided by: | Joslin Diabetes Center |
| ClinicalTrials.gov Identifier: | NCT01073020 |
Purpose
There is substantial clinical evidence regarding the safety and efficacy of currently practiced bariatric surgical techniques to improve metabolic control and/or resolve type 2 diabetes (T2DM) in clinically severe obese patients (class 3 obesity). Evidence suggests such procedures have greater effects on insulin secretion and insulin action than that expected from weight loss alone, which has led to the recent claim that such procedures may be useful as a primary treatment for T2DM in the moderately obese population. Concurrently, there have also been substantial advances in the non-surgical medical management of T2DM. As a result, the best treatment algorithm for T2DM patients with class 1 & 2 obesity is increasingly controversial. This trial investigates the utility of currently practiced and available bariatric surgical procedures as compared with multidisciplinary intensive medical and weight management for the treatment of T2DM with class 1 and 2 obesity.
| Condition | Intervention |
|---|---|
|
Type 2 Diabetes Mellitus Obesity |
Procedure: Laparoscopic Adjustable Gastric Band Procedure: Roux-en-Y Gastric Bypass (Surgery) Other: Intensive Medical Diabetes & Weight Management Device: Allergan Adjustable Gastric Band |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Surgery or Lifestyle With Intensive Medical Management in the Treatment of Type 2 Diabetes (SLIMM-T2D) |
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Gastric Band vs Intensive Medical Diabetes & Weight Management |
Procedure: Laparoscopic Adjustable Gastric Band
Allergan Adjustable Gastric Band (Device) compared to Medical-Behavioural-Nutritional Diabetes and Weight Management (Why WAIT? Program)
Other Names:
Other: Intensive Medical Diabetes & Weight Management
Intensive Medical Diabetes & Weight Management
Device: Allergan Adjustable Gastric Band
Allergan Adjustable Gastric Band (Device) compared to Medical-Behavioural-Nutritional Diabetes and Weight Management (Why WAIT? Program)
|
| Active Comparator: RYGB vs Intensive Medical Diabetes & Weight Management |
Procedure: Roux-en-Y Gastric Bypass (Surgery)
Roux-en-Y Gastric Bypass (Surgery) versus Medical-Behavioural-Nutritional Diabetes and Weight Management (Why WAIT? Program)
Other Names:
Other: Intensive Medical Diabetes & Weight Management
Intensive Medical Diabetes & Weight Management
|
Eligibility| Ages Eligible for Study: | 21 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Massachusetts | |
| Brigham and Women's Hospital | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Contact: Kerri Clancy, RN 617-525-7388 BWHSLIMMT2D@partners.org | |
| Principal Investigator: David Lautz, MD | |
| Joslin Diabetes Center | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Contact: Florencia Halperin, MD 617-309-2400 ext 4613 florencia.halperin@joslin.harvard.edu | |
| Principal Investigator: Allison B. Goldfine, MD | |
| Principal Investigator: | Allison B. Goldfine, MD | Joslin Diabetes Center |
| Principal Investigator: | David Lautz, MD | Brigham and Women's Hospital |
More Information
| Responsible Party: | Allison B. Goldfine, Joslin Diabetes Center |
| ClinicalTrials.gov Identifier: | NCT01073020 History of Changes |
| Other Study ID Numbers: | 2009P-001610 |
| Study First Received: | February 16, 2010 |
| Last Updated: | July 12, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Type 2 Diabetes Mellitus Obesity Lifestyle |
Bariatric Surgery Laparoscopic Adjustable Gastric Band Laparoscopic Roux-en-Y Gastric Bypass |
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Obesity Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms |