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

This study is currently recruiting participants.

Verified by University of Minnesota - Clinical and Translational Science Institute, December 2009

First Received: October 16, 2008 Last Updated: December 10, 2009 History of Changes

Sponsor:	University of Minnesota - Clinical and Translational Science Institute
Information provided by:	University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:	NCT00775164

Purpose

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.

Condition	Intervention	Phase
Obesity Insulin Resistance	Drug: pioglitazone Drug: Metformin	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Pioglitazone Therapy in Obese Children With Insulin Resistance: A Randomized, Controlled Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol Obesity Obesity in Children

Drug Information available for: Insulin Pioglitazone Pioglitazone hydrochloride Metformin Metformin hydrochloride

U.S. FDA Resources

Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:

HDL cholesterol, triglycerides, blood pressure, insulin resistance, endothelial function, arterial stiffness, adipokines, oxidative stress, and blood biomarkers of endothelial activation [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	January 2009
Estimated Study Completion Date:	February 2011
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
pioglitazone: Experimental	Drug: pioglitazone 15 mg per day for 4 weeks, then up-titrated to 30 mg per day for 12 weeks
Metformin: Active Comparator	Drug: Metformin Metformin XR; 1000 mg once daily

Show Detailed Description

Eligibility

Ages Eligible for Study:	10 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00775164

Contacts

Contact: Andrea Metzig, M.A., CCRC

612-625-3623

thel0041@umn.edu

Locations

United States, Minnesota
University of Minnesota General Clinical Research Center	Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Andrea Metzig, M.A., CCRC 612-625-3623 thel0041@umn.edu
Principal Investigator: Aaron S. Kelly, Ph.D.

Sponsors and Collaborators

University of Minnesota - Clinical and Translational Science Institute

Investigators

Principal Investigator:

Aaron S. Kelly, Ph.D.

University of Minnesota - Clinical and Translational Science Institute

More Information

No publications provided

Responsible Party:	University of Minnesota ( Aaron S. Kelly, Ph.D. )
Study ID Numbers:	0811M53986
Study First Received:	October 16, 2008
Last Updated:	December 10, 2009
ClinicalTrials.gov Identifier:	NCT00775164 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:

Obese children with insulin resistance

Additional relevant MeSH terms:

Obesity
Metabolic Diseases
Pioglitazone
Physiological Effects of Drugs
Metformin
Overweight
Pharmacologic Actions
Insulin

Body Weight
Hyperinsulinism
Signs and Symptoms
Hypoglycemic Agents
Nutrition Disorders
Overnutrition
Insulin Resistance
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010