Status:
WITHDRAWN
Pioglitazone Therapy in Obese Children With Insulin Resistance: A Randomized, Controlled Pilot Study
Lead Sponsor:
University of Minnesota
Conditions:
Obesity
Insulin Resistance
Eligibility:
All Genders
10-17 years
Phase:
PHASE4
Brief Summary
The primary objective of this study is to examine the effects of four months of pioglitazone vs. metformin treatment on HDL cholesterol, triglycerides, blood pressure, insulin resistance, endothelial ...
Detailed Description
Background and Specific Aim/Hypothesis Obese, insulin resistant children are at increased risk of future cardiovascular disease due to elevated systolic blood pressure, fasting insulin, triglycerides,...
Eligibility Criteria
Inclusion
- Age 10-17 years old
- Subject able to give assent, and parent/guardian capable of giving consent on behalf of the child
- Body mass index (BMI) ≥ 95th percentile (based on gender and age)
- Fasting insulin ≥ 15 µU/mL AND one or more of the following (cutoffs based on the International Diabetes Federation definition of pediatric metabolic syndrome)1:
- Triglycerides ≥ 150 mg/dL
- HDL cholesterol \< 40 mg/dL
- Systolic blood pressure ≥ 130 mmHg
Exclusion
- Type 1 or 2 diabetes mellitus
- Has begun a new drug therapy within the past 30 days prior to the screening visit
- BMI ≥ 55
- History of weight loss surgery
- Obesity from a genetic cause (e.g., Prader-Willi)
- Central nervous system injury or severe neurological impairment
- Known systolic or diastolic dysfunction or heart failure
- Females who are currently pregnant or planning to become pregnant
- Liver enzymes \> 2.5 times upper limit of normal
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00775164
Start Date
January 1 2009
End Date
February 1 2011
Last Update
August 31 2012
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