Pioglitazone Therapy in Obese Children With Insulin Resistance: A Randomized, Controlled Pilot Study

• Status: Withdrawn
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

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 function, arterial stiffness, adipokines, oxidative stress, and blood biomarkers of endothelial activation in obese insulin resistant children. 30 obese children with elevated fasting insulin levels will be randomly assigned to pioglitazone or metformin for 16 weeks. Change in clinical variables over the 16-week study period will be compared between groups.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Minnesota; University of Minnesota - Clinical and Translational Science Institute
• Treatments: Insulin; Metformin; Pioglitazone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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