- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01859013
Topiramate in Adolescents With Severe Obesity
BMI Reduction With Meal Replacements + Topiramate in Adolescents With Severe Obesity
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Topiramate
Four (4) weeks of meal replacement therapy, followed by 28-weeks of topiramate therapy.
Topiramate will be initiated at a dose of 25 mg (taken orally once daily in the evening), escalated to 50 mg (taken orally once daily in the evening) after 1 week, and escalated to 75 mg (taken orally 25 mg in the morning and 50 mg in the evening) after 2 weeks.
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Topiramate will be initiated at a dose of 25 mg (taken orally once daily in the evening), escalated to 50 mg (taken orally once daily in the evening) after 1 week, and escalated to 75 mg (taken orally 25 mg in the morning and 50 mg in the evening) after 2 weeks.
Patients who do not tolerate dose escalation will be reduced to the highest tolerated dose for the remainder of the trial.
Other Names:
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PLACEBO_COMPARATOR: Sugar Pill
Four (4) weeks of meal replacement therapy, followed by 28-weeks of placebo (sugar pill) therapy.
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Placebo will be taken orally once daily in the evening for the first two weeks, and orally twice daily (AM and PM) for the remainder of the study.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent Change From Baseline in Body Mass Index at 28-Weeks
Time Frame: Baseline and 28-Weeks
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The Percent Change from Baseline in Body Mass Index at 28-Weeks
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Baseline and 28-Weeks
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1304M31241
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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