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Topiramate in Adolescents With Severe Obesity

Information source: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Obesity, Morbid; Obesity; Weight Loss

Intervention: Topiramate (Drug); Placebo (Other)

Phase: Phase 2

Status: Recruiting

Sponsored by: University of Minnesota - Clinical and Translational Science Institute

Official(s) and/or principal investigator(s):
Aaron S Kelly, Ph.D., Principal Investigator, Affiliation: University of Minnesota - Clinical and Translational Science Institute

Overall contact:
Cameron E Naughton, MPA, Phone: 612-625-3623, Email: naug0009@umn.edu

Summary

The prevalence of severe pediatric obesity is on the rise and youth with this condition are at elevated risk for developing chronic diseases such as cardiovascular disease (CVD) and type 2 diabetes mellitus (T2DM). Topiramate, a medication approved by the Food and Drug Administration (FDA) for the treatment of seizures in adults and children, is associated with weight loss. Although not FDA approved for the treatment of obesity, studies in obese adults have demonstrated weight reduction of approximately 5% with 6-12 months of therapy. However, the weight loss effect of topiramate has never been evaluated among children and adolescents. Therefore, the goal of this pilot study is to evaluate the safety and efficacy of 24 weeks of topiramate therapy with a 4-week run-in of meal replacement therapy in adolescents with severe obesity. The primary hypothesis is that 4 weeks of meal replacement therapy followed by 24 weeks of topiramate will have a larger average percent decline in BMI between baseline and 28 weeks compared to meal replacement therapy followed by placebo.

Clinical Details

Official title: BMI Reduction With Meal Replacements + Topiramate in Adolescents With Severe Obesity

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Percent Change from Baseline in Body Mass Index at 28-Weeks

Detailed description: The prevalence of severe pediatric obesity is on the rise and youth with this condition are at elevated risk for developing chronic diseases such as cardiovascular disease (CVD) and type 2 diabetes mellitus (T2DM). Lifestyle modification therapy alone is ineffective for most adolescents with severe obesity and few patients qualify for bariatric surgery. Many patients would likely benefit from pharmacotherapy but only one medication (orlistat) is approved for use in adolescents but notable side effects and limited efficacy impede its clinical use. Topiramate, a medication approved by the Food and Drug Administration (FDA) for the treatment of seizures in adults and children, is associated with weight loss. Although not FDA approved for the treatment of obesity, studies in obese adults have demonstrated weight reduction of approximately 5% with 6-12 months of therapy. However, the weight loss effect of topiramate has never been evaluated among children and adolescents. Therefore, the goal of this pilot study is to evaluate the safety and efficacy of 24 weeks of topiramate therapy with a 4-week run-in of meal replacement therapy in adolescents with severe obesity. This will be a 28-week, randomized, double-blind, placebo-controlled, pilot clinical trial of meal replacement therapy (4 weeks) followed by topiramate (24 weeks) vs. meal replacement therapy (4 weeks) followed by placebo (24 weeks) for BMI reduction and cardiometabolic risk factor improvement in 36 adolescents (ages 12-17 years old) with severe obesity. Monthly lifestyle modification/behavioral counseling will be delivered by trained study coordinators to patients in both groups. The lifestyle modification education materials will be given to patients and selected sections will be discussed at each monthly contact (five face-to-face sessions and three phone sessions). The primary object is to evaluate the effect of meal replacement therapy followed by topiramate vs. meal replacement therapy followed by placebo on percent change in BMI among adolescents with severe obesity. The primary hypothesis is that 4 weeks of meal replacement therapy followed by 24 weeks of topiramate will have a larger average percent decline in BMI between baseline and 28 weeks compared to meal replacement therapy followed by placebo. The secondary objective is to characterize the safety profile of topiramate for the treatment of adolescent obesity, evaluate the effects of meal replacement therapy followed by topiramate vs. meal replacement therapy followed by placebo on risk factors for CVD and T2DM, and evaluate response to topiramate treatment based on baseline eating behavior phenotype in adolescents with severe obesity. The secondary hypothesis is that 4 weeks of meal replacement therapy followed by 24 weeks of topiramate will significantly reduce average absolute BMI, absolute and percent body weight, percent total body and visceral fat, systolic blood pressure, fasting triglycerides and insulin, compared to meal replacement therapy followed by placebo, and that the presence of binge eating disorder characteristics at baseline will be associated with greater reduction in BMI with topiramate treatment.

Eligibility

Minimum age: 12 Years. Maximum age: 17 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- BMI ≥1. 2 times the 95th percentile (based on gender and age) or BMI ≥35 kg/m2

- 12-18 years old

- Tanner stage IV or V by physical exam

Exclusion Criteria:

- Tanner stage I, II, or III

- Type 1 or 2 diabetes mellitus

- Previous (within 6-months) or current use of weight loss medication (patients may

undergo washout)

- Previous (within 6-months) or current use of drugs associated with weight gain (e. g.

steroids/anti-psychotics)

- Previous bariatric surgery

- Recent initiation (within 3-months) of anti-hypertensive or lipid medication

- Previous (within 6-months) or current use of medication to treat insulin resistance

or hyperglycemia (patients may undergo washout)

- Major psychiatric disorder

- Females: Pregnant, planning to become pregnant, or unwilling to use 2 or more

acceptable methods of contraception when engaging in sexual activity throughout the study

- Tobacco use

- Liver/renal dysfunction

- ALT or AST >2. 5 times the upper limit of normal

- Bicarbonate <18 mmol/L

- Creatinine >1. 2 mg/dL

- Glaucoma

- Obesity associated with genetic disorder (monogenetic obesity)

- Hyperthyroidism or uncontrolled hypothyroidism

- History of suicidal thought/attempts

- History of kidney stones

- History of cholelithiasis

- Current use of other carbonic anhydrase inhibitor

Locations and Contacts

Cameron E Naughton, MPA, Phone: 612-625-3623, Email: naug0009@umn.edu

University of Minnesota, Minneapolis, Minnesota 55455, United States; Recruiting
Cameron E Naughton, MPA, Phone: 612-625-3623, Email: naug0009@umn.edu
Ann E Sheldon, B.S., Phone: 612-624-3137, Email: shel0230@umn.edu
Aaron S Kelly, Ph.D., Principal Investigator
Additional Information

Starting date: June 2013
Last updated: May 26, 2015

Page last updated: August 23, 2015

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