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Surgery or Lifestyle With Intensive Medical Management in the Treatment of Type 2 Diabetes

2014-08-27 03:15:43 | BioPortfolio

Summary

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.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Type 2 Diabetes Mellitus

Intervention

Laparoscopic Adjustable Gastric Band, Roux-en-Y Gastric Bypass (Surgery), Intensive Medical Diabetes & Weight Management, Allergan Adjustable Gastric Band

Location

Brigham and Women's Hospital
Boston
Massachusetts
United States
02215

Status

Recruiting

Source

Joslin Diabetes Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:43-0400

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