CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 12 enrolled
Drug / intervention
Exenatidedrug
Likely dose
Exenatide 10 mcgfrom 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/NCT00886626
NCT00886626Phase 2Completed

GLP-1 Therapy for Weight Loss and Improved Glucose Tolerance in Obese Children: A Randomized, Controlled, Pilot Study

University of Minnesota·interventional·Posted Apr 23, 2009·Updated Oct 29, 2012

In Brief

A Phase 2 clinical trial evaluating Exenatide for Obesity, Morbid. Completed, enrolled 12 participants across 1 site.

Detailed Summary

The prevalence of severely obese children is on the rise. Behavioral therapies for weight loss are successful in some, but others need more aggressive approaches such as drug therapy. In addition, up to 25% of severely obese children have impaired glucose tolerance (IGT), which places them at significantly elevated risk of developing type 2 diabetes mellitus and cardiovascular disease. Although various drug therapies for weight loss and IGT have been explored in adults, few have been evaluated in children. Recently, a new drug class has emerged that targets deficiencies of GLP-1. One of the main glycemic mechanisms of action of the GLP-1 agonists such as exenatide is to enhance glucose disposal in the postprandial setting and improve glucose tolerance. In addition, exenatide can induce weight loss by decreasing appetite and slowing gastric motility.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity, Morbid
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 23, 2009
Enrollment StartMay 1, 2009
Primary CompletionFeb 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 17.2 years ago

Interventions

Exenatidedrug

Exenatide, subcutaneous injection, 10 mcg, twice per day