Document Detail


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.
MedLine Citation:
PMID:  23380890     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
Aaron S Kelly; Kyle D Rudser; Brandon M Nathan; Claudia K Fox; Andrea M Metzig; Brandon J Coombes; Angela K Fitch; Eric M Bomberg; M Jennifer Abuzzahab
Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  JAMA pediatrics     Volume:  167     ISSN:  2168-6211     ISO Abbreviation:  JAMA Pediatr     Publication Date:  2013 Apr 
Date Detail:
Created Date:  2013-04-02     Completed Date:  2013-06-24     Revised Date:  2014-05-07    
Medline Journal Info:
Nlm Unique ID:  101589544     Medline TA:  JAMA Pediatr     Country:  United States    
Other Details:
Languages:  eng     Pagination:  355-60     Citation Subset:  AIM; IM    
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT01237197
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MeSH Terms
Descriptor/Qualifier:
Adolescent
Body Constitution / drug effects
Body Mass Index*
Double-Blind Method
Female
Glucagon-Like Peptide 1 / agonists*
Humans
Hypoglycemic Agents / pharmacology*
Male
Peptides / pharmacology*
Receptors, Glucagon / agonists*
Satiety Response / drug effects*
Venoms / pharmacology*
Grant Support
ID/Acronym/Agency:
1UL1RR033183/RR/NCRR NIH HHS; 8UL1TR000114-02/TR/NCATS NIH HHS; UL1 RR033183/RR/NCRR NIH HHS; UL1 TR000114/TR/NCATS NIH HHS
Chemical
Reg. No./Substance:
0/Hypoglycemic Agents; 0/Peptides; 0/Receptors, Glucagon; 0/Venoms; 0/glucagon-like peptide-1 receptor; 89750-14-1/Glucagon-Like Peptide 1; 9P1872D4OL/exenatide
Comments/Corrections
Comment In:
JAMA Pediatr. 2013 Apr;167(4):391-3   [PMID:  23381196 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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