CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 88 enrolled
Drug / intervention
Allergan Adjustable Gastric Band Surgery +3 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01073020
NCT01073020N/ACompleted

Surgery or Lifestyle With Intensive Medical Management in the Treatment of Type 2 Diabetes (SLIMM-T2D)

Joslin Diabetes Center·interventional·Posted Feb 22, 2010·Updated Jun 28, 2021

In Brief

A clinical study evaluating Allergan Adjustable Gastric Band Surgery, Intensive Medical Diabetes & Weight Management (Why WAIT) - Band Group, and 2 other interventions for Type 2 Diabetes Mellitus and Obesity. Completed, enrolled 88 participants across 2 sites.

Detailed 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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 22, 2010
Enrollment StartJan 1, 2010
Primary CompletionDec 1, 2014
Study CompletionNov 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 16.4 years ago

Interventions

Allergan Adjustable Gastric Band Surgerydevice

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

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

Roux-en-Y Gastric Bypass (RYGB) Surgeryprocedure

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

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