Status:
COMPLETED
Topiramate in Adolescents With Severe Obesity
Lead Sponsor:
University of Minnesota
Conditions:
Obesity, Morbid
Obesity
Eligibility:
All Genders
12-17 years
Phase:
PHASE2
Brief 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 me...
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 me...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2017
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT01859013
Start Date
June 1 2013
End Date
April 1 2017
Last Update
July 2 2017
Active Locations (1)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55455