Claudia K Fox1,2, Justin M Clark2,3, Kyle D Rudser2,3, Justin R Ryder1,2, Amy C Gross1,2, Brandon M Nathan1,2, Muna Sunni1,2, Donald R Dengel2,4, Charles J Billington5, Megan O Bensignor1,2, Aaron S Kelly1,2. 1. Department of Pediatrics, University of Minnesota Medical School, Minneapolis, Minnesota, USA. 2. Center for Pediatric Obesity Medicine, University of Minnesota Medical School, Minneapolis, Minnesota, USA. 3. Division of Biostatistics, University of Minnesota, Minneapolis, Minnesota, USA. 4. School of Kinesiology, University of Minnesota, Minneapolis, Minnesota, USA. 5. Department of Medicine, University of Minnesota Medical School and Veteran's Affairs Medical Center, Minneapolis, Minnesota, USA.
Abstract
OBJECTIVE: This study sought to evaluate the effect of 52 weeks of exenatide extended release (XR) on the maintenance of meal replacement therapy (MRT)-induced BMI reduction in adolescents with severe obesity. METHODS: In this randomized, double-blind, placebo-controlled trial, 100 participants aged 12 to 18 years with BMI ≥ 1.2 × 95th percentile were enrolled in a short-term MRT run-in phase. Those who achieved ≥5% BMI reduction during the run-in were then randomized to 52 weeks of exenatide XR 2.0 mg or placebo weekly. Both groups also received lifestyle therapy. The prespecified primary end point was mean percent change in BMI from randomization (post run-in) to 52 weeks in the intention-to-treat population. RESULTS: A total of 100 participants were enrolled, and 66 (mean age 16 = [SD 1.5] years; 47% female) achieved ≥5% BMI reduction with MRT and were randomized (33 to exenatide XR and 33 to placebo). From randomization (post run-in) to 52 weeks, mean BMI increased 4.6% and 10.1% in the exenatide XR and placebo groups, respectively. The placebo-subtracted exenatide XR treatment effect was -4.1% (95% CI: -8.6% to 0.5%, p = 0.078). CONCLUSIONS: Although not achieving statistical significance, exenatide XR, compared with placebo, may partly mitigate the propensity toward BMI rebound in adolescents who achieved initial weight loss with dietary intervention.
OBJECTIVE: This study sought to evaluate the effect of 52 weeks of exenatide extended release (XR) on the maintenance of meal replacement therapy (MRT)-induced BMI reduction in adolescents with severe obesity. METHODS: In this randomized, double-blind, placebo-controlled trial, 100 participants aged 12 to 18 years with BMI ≥ 1.2 × 95th percentile were enrolled in a short-term MRT run-in phase. Those who achieved ≥5% BMI reduction during the run-in were then randomized to 52 weeks of exenatide XR 2.0 mg or placebo weekly. Both groups also received lifestyle therapy. The prespecified primary end point was mean percent change in BMI from randomization (post run-in) to 52 weeks in the intention-to-treat population. RESULTS: A total of 100 participants were enrolled, and 66 (mean age 16 = [SD 1.5] years; 47% female) achieved ≥5% BMI reduction with MRT and were randomized (33 to exenatide XR and 33 to placebo). From randomization (post run-in) to 52 weeks, mean BMI increased 4.6% and 10.1% in the exenatide XR and placebo groups, respectively. The placebo-subtracted exenatide XR treatment effect was -4.1% (95% CI: -8.6% to 0.5%, p = 0.078). CONCLUSIONS: Although not achieving statistical significance, exenatide XR, compared with placebo, may partly mitigate the propensity toward BMI rebound in adolescents who achieved initial weight loss with dietary intervention.
Authors: Aaron S Kelly; Andrea M Metzig; Kyle D Rudser; Angela K Fitch; Claudia K Fox; Brandon M Nathan; Mary M Deering; Betsy L Schwartz; M Jennifer Abuzzahab; Laura M Gandrud; Antoinette Moran; Charles J Billington; Sarah J Schwarzenberg Journal: Obesity (Silver Spring) Date: 2011-11-10 Impact factor: 5.002
Authors: Paul A Harris; Robert Taylor; Robert Thielke; Jonathon Payne; Nathaniel Gonzalez; Jose G Conde Journal: J Biomed Inform Date: 2008-09-30 Impact factor: 6.317
Authors: Patrick M O'Neil; Andreas L Birkenfeld; Barbara McGowan; Ofri Mosenzon; Sue D Pedersen; Sean Wharton; Charlotte Giwercman Carson; Cecilie Heerdegen Jepsen; Maria Kabisch; John P H Wilding Journal: Lancet Date: 2018-08-16 Impact factor: 79.321
Authors: Arne Astrup; Ian Caterson; Pierre Zelissen; Bernard Guy-Grand; Michele Carruba; Brian Levy; Xiang Sun; Martin Fitchet Journal: Obes Res Date: 2004-10
Authors: Claudia K Fox; Alexander M Kaizer; Kyle D Rudser; Brandon M Nathan; Amy C Gross; Muna Sunni; M Jennifer Abuzzahab; Betsy L Schwartz; Seema Kumar; Anna Petryk; Charles J Billington; Justin R Ryder; Aaron S Kelly Journal: Obesity (Silver Spring) Date: 2016-11-03 Impact factor: 5.002
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 Journal: JAMA Pediatr Date: 2013-04 Impact factor: 16.193