Overview

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

Status:
Completed
Trial end date:
2008-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Yale University
Treatments:
Rosiglitazone
Criteria
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.