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

NCT00775164 | Withdrawn Phase 4 DMC

• 1 other identifier: 0811M53986
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Obesity; Insulin Resistance

Keywords

Obese children with insulin resistance

Outcome Measures

Primary Outcomes (1)

• HDL cholesterol, triglycerides, blood pressure, insulin resistance, endothelial function, arterial stiffness, adipokines, oxidative stress, and blood biomarkers of endothelial activation

  16 weeks

Study Arms (2)

pioglitazone

EXPERIMENTAL

Pioglitazone: 15 mg per day for 4 weeks, then up-titrated to 30 mg per day for 12 weeks

Drug: pioglitazone

Metformin

ACTIVE COMPARATOR

Metformin XR; 1000 mg once daily for 16 weeks.

Drug: Metformin

Interventions

pioglitazone DRUG

15 mg per day for 4 weeks, then up-titrated to 30 mg per day for 12 weeks

Also known as: ACTOS

pioglitazone

Metformin DRUG

Metformin XR; 1000 mg once daily

Also known as: Glucophage XR

Metformin

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

MeSH Terms

Conditions

Obesity; Insulin Resistance

Interventions

Pioglitazone; Metformin

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Biguanides; Guanidines; Amidines

Study Officials

• Aaron S. Kelly, Ph.D.

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2008
• First Posted: October 20, 2008
• Study Start: January 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: February 1, 2011
• Last Updated: August 31, 2012

Record last verified: 2012-08