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

This study has been withdrawn prior to enrollment.
(Inadequate enrollment)
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00775164
First received: October 16, 2008
Last updated: August 30, 2012
Last verified: August 2012
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Pioglitazone Therapy in Obese Children With Insulin Resistance: A Randomized, Controlled Pilot Study

Resource links provided by NLM:


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 ]

Enrollment: 0
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
Experimental: pioglitazone
Pioglitazone: 15 mg per day for 4 weeks, then up-titrated to 30 mg per day for 12 weeks
Drug: pioglitazone
15 mg per day for 4 weeks, then up-titrated to 30 mg per day for 12 weeks
Other Name: ACTOS
Active Comparator: Metformin
Metformin XR; 1000 mg once daily for 16 weeks.
Drug: Metformin
Metformin XR; 1000 mg once daily
Other Name: Glucophage XR

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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 - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00775164     History of Changes
Other Study ID Numbers: 0811M53986
Study First Received: October 16, 2008
Last Updated: August 30, 2012
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:
Insulin Resistance
Obesity
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Pioglitazone
Insulin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014