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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00413335
• Other study ID #: 0508000532
• Status: Completed
• Phase: N/A
• First received: December 15, 2006
• Last updated: July 15, 2013
• Start date: November 2005
• Est. completion date: December 2008

Study information

• Verified date: July 2013
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 18 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Glucose Intolerance
• Impaired Glucose Tolerance
• Obesity
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Rosiglitazone
2mg to begin then 4mg, twice daily for 4 months
• Placebo
Subject receives placebo.

Locations

Country	Name	City	State
United States	Yale School of Medicine	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Percent Change From Baseline in Whole-body Insulin Sensitivity	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).	4 months	No
Primary	Mean Percent Change in Visceral-to-subcutaneous Abdominal Fat	This describes the percent changes of the ratio between visceral and subcutaneous abdominal fat.	4 months	No
Primary	Percentage of Subjects Who Converted Impaired Glucose Tolerance (IGT) to Normal Glucose Tolerance (NGT)	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 months	No
Primary	Mean Percent Change From Baseline in Hepatic Fat Fraction (HFF)	It refers to the percent changes of hepatic fat content.	4 months	No
Secondary	Mean Percent Change From Baseline in Adiponectin	This refers to the changes of adiponectin levels.	4 months	No