Meal replacements followed by topiramate for the treatment of adolescent severe obesity: A pilot randomized controlled trial.
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.



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.



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.



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.
Department of Pediatrics, University of Minnesota, Minneapolis, Minnesota, USA.
Claudia K
CK
Fox
Division of Biostatistics, University of Minnesota, Minneapolis, Minnesota, USA.
Alexander M
AM
Kaizer
Division of Biostatistics, University of Minnesota, Minneapolis, Minnesota, USA.
Kyle D
KD
Rudser
Department of Pediatrics, University of Minnesota, Minneapolis, Minnesota, USA.
Brandon M
BM
Nathan
Department of Pediatrics, University of Minnesota, Minneapolis, Minnesota, USA.
Amy C
AC
Gross
Department of Pediatrics, University of Minnesota, Minneapolis, Minnesota, USA.
Muna
M
Sunni
Children's Hospitals and Clinics of Minnesota, Minneapolis, Minnesota, USA.
M
M
Jennifer Abuzzahab
International Diabetes Center at Park Nicollet, St. Louis Park, Minnesota, USA.
Betsy L
BL
Schwartz
Mayo Clinic, Rochester, Minnesota, USA.
Seema
S
Kumar
Department of Pediatrics, University of Minnesota, Minneapolis, Minnesota, USA.
Anna
A
Petryk
Veterans Affairs Health Care System, Minneapolis, Minnesota, USA.|Department of Medicine, University of Minnesota, Minneapolis, Minnesota, USA.
Charles J
CJ
Billington
Department of Pediatrics, University of Minnesota, Minneapolis, Minnesota, USA.
Justin R
JR
Ryder
Department of Pediatrics, University of Minnesota, Minneapolis, Minnesota, USA.|Department of Medicine, University of Minnesota, Minneapolis, Minnesota, USA.
Aaron S
AS
Kelly
D000293:Adolescent; D019440:Anti-Obesity Agents / Q000008:administration & dosage*; D001824:Body Constitution / Q000187:drug effects; D015992:Body Mass Index; D004311:Double-Blind Method; D005260:Female; D005632:Fructose / Q000008:administration & dosage / Q000031:analogs & derivatives*; D006801:Humans; D008079:Lipoproteins, VLDL / Q000097:blood; D008297:Male; D062407:Meals; D063766:Pediatric Obesity / Q000097:blood / Q000188:drug therapy*; D010865:Pilot Projects; D000077236:Topiramate; D016896:Treatment Outcome
D019440:Anti-Obesity Agents; D008079:Lipoproteins, VLDL; D000077236:Topiramate; D005632:Fructose