Status:
COMPLETED
Effects of Rosiglitazone on the Metabolic Phenotype of Impaired Glucose Tolerance in Youth
Lead Sponsor:
Yale University
Conditions:
Obesity
Impaired Glucose Tolerance
Eligibility:
All Genders
10-18 years
Phase:
NA
Brief 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 glu...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00413335
Start Date
November 1 2005
End Date
December 1 2008
Last Update
July 22 2013
Active Locations (1)
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1
Yale School of Medicine
New Haven, Connecticut, United States, 06520