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Exenatide in Extreme Pediatric Obesity

NCT01237197 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2014-09-12

Study results available
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Summary

Extreme pediatric obesity, the fastest growing category of obesity in youth, is associated with high risk for developing cardiovascular disease (CVD) and type 2 diabetes (T2DM). Obesity tracks strongly into adulthood and interventions early in life may reduce risk for developing cardiovascular disease and type 2 diabetes. Few drug therapies for weight loss have been evaluated in adolescents. Since exenatide is associated with weight loss and improves risk factors for cardiovascular disease and type 2 diabetes in adults, it may be useful in extremely obese youth. Our primary objective in this study is to generate preliminary data on the ability of exenatide to reduce body mass index (BMI) and improve risk factors for cardiovascular disease and type 2 diabetes in 26 extremely obese adolescents (age 12-19 years) in a three-month, randomized, double-blind, placebo-controlled pilot clinical trial. GLP-1 therapy has never been evaluated as a treatment for pediatric obesity and is an innovative approach to a challenging and significant health care problem.

Conditions

Interventions

DRUG

Exenatide

Exenatide 5 micrograms (mcg) twice per day (BID) for one month; up-titrated to 10 mcg twice per day for remainder of study.

DRUG

Placebo

Participants were randomized to a placebo injection for the first three months, then given open-label Exenatide for the remaining three months (Initiated at 5 mcg, twice per day, delivered by subcutaneous injection. After 1 month, exenatide was uptitrated to 10 mcg, twice per day for the remaining 2 months of the drug treatment phase).

Sponsors & Collaborators

Principal Investigators

  • Aaron S. Kelly, Ph.D. · University of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2012-05-31
Completion
2012-10-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT01237197 on ClinicalTrials.gov