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

NCT01073020 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2021-06-28

Study results available
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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.

Conditions

Interventions

DEVICE

Allergan Adjustable Gastric Band Surgery

OTHER

Intensive Medical Diabetes & Weight Management (Why WAIT) - Band Group

Intensive Medical Diabetes \& Weight Management (Why WAIT) - Band Group

PROCEDURE

Roux-en-Y Gastric Bypass (RYGB) Surgery

OTHER

Intensive Medical Diabetes & Weight Management (Why WAIT) - Bypass Group

Intensive Medical Diabetes \& Weight Management (Why WAIT) - Bypass Group

Sponsors & Collaborators

  • Brigham and Women's Hospital

    collaborator OTHER

  • Joslin Diabetes Center

    lead OTHER

Principal Investigators

  • Allison B. Goldfine, MD · Joslin Diabetes Center

  • Ashley Vernon, MD · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2014-12-31
Completion
2016-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01073020 on ClinicalTrials.gov