title: 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.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  Three-month, randomized, double-blind, placebo-controlled, multicenter clinical trial followed by a 3-month open-label extension.
  
  
  METHODS
  An academic medical center and an outpatient pediatric endocrinology clinic.
  
  
  METHODS
  A total of 26 adolescents (12-19 years of age) with severe obesity (BMI ≥ 1.2 times the 95th percentile or BMI ≥ 35).
  
  
  METHODS
  All patients received lifestyle modification counseling and were equally randomized to exenatide or placebo injection, twice per day.
  
  
  METHODS
  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
  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.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT01237197.
authors: Department of Pediatrics, University of Minnesota Medical School, 420 Delaware St, SE, MMC 715, Minneapolis, MN 55455, USA. kelly105@umn.edu
authors: Aaron S
authors: AS
authors: Kelly
authors: Kyle D
authors: KD
authors: Rudser
authors: Brandon M
authors: BM
authors: Nathan
authors: Claudia K
authors: CK
authors: Fox
authors: Andrea M
authors: AM
authors: Metzig
authors: Brandon J
authors: BJ
authors: Coombes
authors: Angela K
authors: AK
authors: Fitch
authors: Eric M
authors: EM
authors: Bomberg
authors: M Jennifer
authors: MJ
authors: Abuzzahab
mesh_terms: D000293:Adolescent; D001824:Body Constitution / Q000187:drug effects; D015992:Body Mass Index; D004311:Double-Blind Method; D000077270:Exenatide; D005260:Female; D052216:Glucagon-Like Peptide 1 / Q000819:agonists*; D000067757:Glucagon-Like Peptide-1 Receptor; D006801:Humans; D007004:Hypoglycemic Agents / Q000494:pharmacology*; D008297:Male; D010455:Peptides / Q000494:pharmacology*; D018027:Receptors, Glucagon / Q000819:agonists*; D012528:Satiety Response / Q000187:drug effects*; D014688:Venoms / Q000494:pharmacology*
chemical_list: C000593833:GLP1R protein, human; D000067757:Glucagon-Like Peptide-1 Receptor; D007004:Hypoglycemic Agents; D010455:Peptides; D018027:Receptors, Glucagon; D014688:Venoms; D052216:Glucagon-Like Peptide 1; D000077270:Exenatide
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