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- Title
Meal replacements followed by topiramate for the treatment of adolescent severe obesity: A pilot randomized controlled trial.
- Authors
Fox, Claudia K.; Kaizer, Alexander M.; Rudser, Kyle D.; Nathan, Brandon M.; Gross, Amy C.; Sunni, Muna; Jennifer Abuzzahab, M.; Schwartz, Betsy L.; Kumar, Seema; Petryk, Anna; Billington, Charles J.; Ryder, Justin R.; Kelly, Aaron S.
- Abstract
<bold>Objective: </bold>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.<bold>Methods: </bold>Adolescents (ages 12-18 years) with severe obesity (BMI ≥1.2 times the 95th percentile or BMI ≥35 kg/m2 ) 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.<bold>Results: </bold>Thirty adolescents (mean age 15.2 ± 1.7 years, mean BMI 40.3 ± 4.6 kg/m2 ) 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.<bold>Conclusions: </bold>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.
- Subjects
TOPIRAMATE; OBESITY treatment; RANDOMIZED controlled trials; BODY mass index; ADOLESCENT obesity; COMPARATIVE studies; FRUCTOSE; LIPOPROTEINS; HUMAN constitution; RESEARCH methodology; MEDICAL cooperation; CHILDHOOD obesity; RESEARCH; ANTIOBESITY agents; PILOT projects; EVALUATION research; TREATMENT effectiveness; BLIND experiment
- Publication
Obesity (19307381), 2016, Vol 24, Issue 12, p2553
- ISSN
1930-7381
- Publication type
journal article
- DOI
10.1002/oby.21633