Effects of Rosiglitazone on the Metabolic Phenotype of Impaired Glucose Tolerance in Youth
Obesity, Impaired Glucose Tolerance, Type 2 Diabetes Mellitus
About this trial
This is an interventional prevention trial for Obesity focused on measuring Childhood and Adolescent Obesity, Metabolic phenotype, Impaired Glucose Tolerance, Type 2 Diabetes Mellitus, Insulin Sensitivity, Insulin Resistance, Abdominal fat partitioning, Impaired Glucose Tolerance (IGT), Type 2 Diabetes Mellitus (T2DM)
Eligibility 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.
Sites / Locations
- Yale School of Medicine
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
1
2
Subject undergoes ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, NMR and DEXA scan. Subject then receives Rosiglitazone. Subjects are followed every 2 weeks. Imaging repeated at 2 months. 12 week follow up. And then all tests are repeated at 4 months.
Subject has ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, DEXA, NMR. Subject is randomized (double-blind) to placebo. Is followed every 2 weeks, repeats imaging at 2 months, is seen at 12 weeks and then repeats all tests at 2 months.