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Completed

NCT Number: NCT00413335

Effects of Rosiglitazone on the Metabolic Phenotype of Impaired Glucose Tolerance in Youth

The purpose of the study is to determine whether treatment of children and adolescents with Impaired Glucose Tolerance (IGT) with rosiglitazone will lead to improvements in insulin sensitivity and glucose tolerance.

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Key information

Conditions

Obesity Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Hyperinsulinism Impaired Glucose Tolerance Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms Type 2 Diabetes Mellitus

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale School of Medicine

New Haven, Connecticut, 06520, United States

About this study

Impaired Glucose Tolerance (IGT) is a prelude to diabetes, which is increasing in prevalence in obese children and adolescents with marked obesity. This condition tends to progress to Type 2 Diabetes Mellitus (T2DM) at an alarmingly rapid tempo. The increased prevalence of childhood and adolescent obesity and greater risk of IGT, and progression to diabetes, in this population set the stage for a series of studies aimed at understanding the metabolic phenotype and natural history of pre-diabetes in obese youth. The investigators found that obese children and adolescents with IGT are characterized by marked insulin resistance related to altered lipid partitioning, favoring lipid deposition in the visceral and intramyocellular compartment. Furthermore, the investigators found an impairment of the acute insulin response in these youngsters. Follow-up revealed a rapid deterioration from IGT to frank diabetes. Based on these studies, there is a strong rationale for changing the balance between visceral and subcutaneous fat and muscle lipid content in a more favorable pattern in order to improve insulin sensitivity.

The primary objective of this study is to determine, in a group of ethnically diverse children and adolescents with IGT, whether treatment with rosiglitazone leads to improvements in insulin sensitivity and glucose tolerance. Secondary objectives are to determine whether rosiglitazone is safe and well tolerated.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Good general health
  • Aged 10 to 18 yrs (females: Tanner stage II-V;and males:testes size>6ml)
  • IGT based on 2-hr plasma glucose>140mg/dl and <200mg/dl during an OGTT.

Exclusion criteria

  • Baseline creatinine>1.0mg
  • AST and ALT>2.5 ULN
  • Anemia (Hct<30)
  • Pregnancy (females must have a negative urine pregnancy test during the study)
  • Cardiac or pulmonary or other significant chronic illness
  • Plans to increase the frequency or intensity of a regular exercise program
  • Psychiatric disorder or substance abuse of anorexic agents.

Treatment and study plan

rosiglitazone

Drug

2mg to begin then 4mg, twice daily for 4 months

Other names: Avandia

Placebo

Drug

Subject receives placebo.

Primary outcomes

  1. Mean Percent Change From Baseline in Whole-body Insulin Sensitivity

    Time frame: 4 months

    This describes the percent changes in insulin sensitivity. Insulin sensitivity was expressed as whole body insulin sensitivity index (WBISI) which is based on the values of insulin (microunits per milliliter) and glucose (milligrams per deciliter) obtained from the OGTT and the corresponding fasting values.The formula is: WBISI=10.000/square root of (fasting glucose x fasting insulin)x(mean glucose x mean insulin).

  2. Mean Percent Change in Visceral-to-subcutaneous Abdominal Fat

    Time frame: 4 months

    This describes the percent changes of the ratio between visceral and subcutaneous abdominal fat.

  3. Percentage of Subjects Who Converted Impaired Glucose Tolerance (IGT) to Normal Glucose Tolerance (NGT)

    Time frame: 4 months

    This refers to the number of subjects that converted from IGT to NGT. NGT is defined as fasting glucose lower than 100 mg/dl and 2 hours glucose lower than 140 mg/dl. IGT is defined as 2 hours glucose higher than 140 mg/dl.

  4. Mean Percent Change From Baseline in Hepatic Fat Fraction (HFF)

    Time frame: 4 months

    It refers to the percent changes of hepatic fat content.

Secondary outcomes

  1. Mean Percent Change From Baseline in Adiponectin

    Time frame: 4 months

    This refers to the changes of adiponectin levels.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Dec 19, 2006
Registry last updated
Jul 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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