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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., (© 2022 The Obesity Society.)

Objective: This study aimed to determine whether children and adolescents demonstrate, similarly to adults, a threshold of total percent body fat (%BF) above which the slope of visceral adipose tissue (VAT) rises., Methods: This cross-sectional study included 557 youth, aged 8 to 18 years, with a wide range of BMI values. Dual-energy x-ray absorptiometry was used to determine body composition (including VAT), and fasting blood was collected for measurement of lipids, glucose, insulin, and biomarkers. Segmented linear regression analysis identified the threshold for %BF unadjusted and adjusted for Tanner stage. Linear regression with robust variance estimation compared associations of risk factors and thresholds., Results: Thresholds of %BF were identified by sex (males = 33%, females = 38%), age (< 12 years = 34%; ≥ 12 years = 30%), and race (White/non-Hispanic = 31%; all other races/Hispanic = 38%) above which the slope of VAT was significantly steeper (all P < 0 .001). The percentage of total body fat stored as VAT was higher above versus below these thresholds (all P < 0.001). Above threshold, but not below it, VAT was associated with triglycerides/high-density lipoprotein ratio, insulin, adiponectin, and blood pressure., Conclusions: The thresholds should be confirmed in longitudinal studies, and they may be useful in identifying youth at increased cardiometabolic risk in need of close clinical monitoring and/or intensive intervention to reduce excess adiposity., (© 2019 The Obesity Society.)

Objective: This study aimed to examine whether 1-month BMI improvement is predictive of superior 6- and 12-month BMI changes in a national sample of youth in pediatric weight management treatment., Methods: Participants were 4- to 18-year-olds from the Pediatric Obesity Weight Evaluation Registry, a prospective study collecting data from 31 pediatric weight management programs across the United States. Response at 1 month was defined as ≥ 3% BMI reduction; success at 6 and 12 months was defined as ≥ 5% BMI reduction from baseline. Analyses used linear and logistic regression with robust variance estimation., Results: Primary analyses were completed with 687 participants (mean age 12.2 years). One-month responders demonstrated significant improvements in BMI compared with nonresponders at 6 months (BMI, -2.05 vs. 0.05; %BMI, -5.81 vs. 0.23; P < 0.001 for all) and 12 months (BMI, -1.87 vs. 0.30; %BMI, -5.04 vs. 1.06; P < 0.001 for all). The odds of success for 1-month responders were 9.64 (95% CI: 5.85-15.87; P < 0.001) times that of nonresponders at 6 months and 5.24 (95% CI: 2.49-11.02; P < 0.001) times that of nonresponders at 12 months., Conclusions: In treatment-seeking youth with obesity, early BMI reduction was significantly associated with greater long-term BMI reduction. Nonresponders may benefit from early treatment redirection or intensification., (© 2019 The Obesity Society.)

Objective: To assess the safety and efficacy of short-term meal replacement therapy followed by topiramate for body mass index (BMI) reduction in adolescents with severe obesity., Methods: Adolescents (ages 12-18 years) with severe obesity (BMI ≥1.2 times the 95th percentile or BMI ≥35 kg/m 2 ) were recruited for this double-blind, randomized, placebo-controlled trial. Participants completed 4 weeks of meal replacement therapy followed by randomization (1:1) to either 24 weeks of topiramate 75 mg/day or placebo. Mean changes were compared between groups., Results: Thirty adolescents (mean age 15.2 ± 1.7 years, mean BMI 40.3 ± 4.6 kg/m 2 ) completed the meal replacement phase and were randomized; 21 completed the study. The difference in mean percent change in BMI between the topiramate and placebo groups was not significant (-1.9%; 95% CI: -5.2% to +1.5%; P = 0.291). Significant improvements in visceral fat and very-low-density lipoprotein cholesterol were observed in the topiramate compared with the placebo group. There were no concerning changes in neurocognitive function or bone health., Conclusions: In this pilot study, 4 weeks of meal replacement therapy followed by 24 weeks of low-dose topiramate compared with meal replacement therapy alone did not result in significant BMI reduction for adolescents with severe obesity., (© 2016 The Obesity Society.)