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

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ClinicalTrials.gov Identifier: NCT00775164
Recruitment Status : Withdrawn (Inadequate enrollment)
First Posted : October 20, 2008
Last Update Posted : August 31, 2012
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

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.

Condition or disease Intervention/treatment Phase
Obesity Insulin Resistance Drug: pioglitazone Drug: Metformin Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Pioglitazone Therapy in Obese Children With Insulin Resistance: A Randomized, Controlled Pilot Study
Study Start Date : January 2009
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. HDL cholesterol, triglycerides, blood pressure, insulin resistance, endothelial function, arterial stiffness, adipokines, oxidative stress, and blood biomarkers of endothelial activation [ Time Frame: 16 weeks ]


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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00775164     History of Changes
Other Study ID Numbers: 0811M53986
First Posted: October 20, 2008    Key Record Dates
Last Update Posted: August 31, 2012
Last Verified: August 2012

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Obese children with insulin resistance

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Pioglitazone
Insulin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs