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JAMA Pediatr. 2013 Apr;167(4):355-60. doi: 10.1001/jamapediatrics.2013.1045.

The effect of glucagon-like peptide-1 receptor agonist therapy on body mass index in adolescents with severe obesity: a randomized, placebo-controlled, clinical trial.

Author information

1
Department of Pediatrics, University of Minnesota Medical School, 420 Delaware St, SE, MMC 715, Minneapolis, MN 55455, USA. kelly105@umn.edu

Abstract

IMPORTANCE:

Medical treatment options for pediatric obesity remain limited. Glucagon-like peptide-1 (GLP-1) receptor agonists induce weight loss by suppressing appetite and increasing satiety, but few studies have evaluated this therapy as a treatment for obesity.

OBJECTIVE:

To evaluate the effects of exenatide on body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) and cardiometabolic risk factors in adolescents with severe obesity.

DESIGN:

Three-month, randomized, double-blind, placebo-controlled, multicenter clinical trial followed by a 3-month open-label extension.

SETTING:

An academic medical center and an outpatient pediatric endocrinology clinic.

PATIENTS:

A total of 26 adolescents (12-19 years of age) with severe obesity (BMI ≥ 1.2 times the 95th percentile or BMI ≥ 35).

INTERVENTION:

All patients received lifestyle modification counseling and were equally randomized to exenatide or placebo injection, twice per day.

MAIN OUTCOME MEASURES:

The primary end point was the mean percent change in BMI measured at baseline and 3 months. Secondary end points included absolute change in BMI, body weight, body fat, blood pressure, hemoglobin A1c, fasting glucose, fasting insulin, and lipids at 3 months.

RESULTS:

Twenty-two patients completed the trial. Exenatide elicited a greater reduction in percent change in BMI compared with placebo (-2.70% [95% CI, -5.02% to -0.37%]; P = .03). Similar findings were observed for absolute change in BMI (-1.13 [95% CI, -2.03 to -0.24]; P = .02) and body weight (-3.26 kg [95% CI, -5.87 to -0.66 kg]; P = .02). Although not reaching the level of statistical significance, reduction in systolic blood pressure was observed with exenatide. During the open-label extension, BMI was further reduced in those initially randomized to exenatide (cumulative BMI reduction of 4%).

CONCLUSIONS AND RELEVANCE:

These results provide preliminary evidence supporting the feasibility, safety, and efficacy of GLP-1 receptor agonist therapy for the treatment of severe obesity in adolescents.

TRIAL REGISTRATION:

clinicaltrials.gov Identifier: NCT01237197.

PMID:
23380890
PMCID:
PMC4010226
DOI:
10.1001/jamapediatrics.2013.1045
[Indexed for MEDLINE]
Free PMC Article
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