CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 15 enrolled
Drug / intervention
Gastric Banding +2 moreprocedure
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/NCT01667783
NCT01667783Phase 3Completed

Improving Diabetes Through Lifestyle and Surgery Study

Johns Hopkins University·interventional·Posted Aug 17, 2012·Updated Aug 12, 2024

In Brief

A Phase 3 clinical trial evaluating Gastric Banding, Medical Weight Loss, and 1 other intervention for Obesity and Type 2 Diabetes. Completed, enrolled 15 participants across 1 site.

Detailed Summary

Weight loss is effective in reducing many complications of obesity, with the majority of patients who undergo bariatric surgery having substantial improvements in their weight-related illnesses. The investigators propose a pilot study in 45 subjects with mild to moderate obesity to compare how losing 10% of initial body weight via one of three common weight loss strategies (medical weight loss with a low calorie diet, Roux-en-Y gastric bypass surgery, and adjustable gastric banding) affects diabetes. While the investigators do not expect this pilot study to provide definitive answers, it will provide valuable information to design a larger trial which will help guide therapy for people with mild-moderate obesity and substantial comorbidities.

Study Details

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

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 17, 2012
Enrollment StartAug 1, 2012
Primary CompletionFeb 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 13.9 years ago

Interventions

Gastric Bandingprocedure

Laparoscopic Adjustable Gastric Banding using the LapBand

Medical Weight Lossbehavioral

Weight loss intervention using diet (meal replacments), physical activity and behavioral techniques administered with weekly one-on-one counselling by dieticians

Gastric Bypassprocedure

Laparoscopic Roux-en-Y Gastric Bypass