N/A
N=21
Effects of Rosiglitazone on the Metabolic Phenotype of Impaired Glucose Tolerance in Youth
Obesity · Impaired Glucose Tolerance · Type 2 Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT00413335 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Apr 2013
Primary outcome: Primary: Mean Percent Change From Baseline in Whole-body Insulin Sensitivity — 87.4; 63.1 percentage of change from baseline
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Rosiglitazone (Drug); Placebo (Drug)
- Age
- Pediatric, Adult · 10+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Sep 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Percent Change From Baseline in Whole-body Insulin Sensitivity |
87.4; 63.1 | — |
| PRIMARY Mean Percent Change in Visceral-to-subcutaneous Abdominal Fat |
-7.3; 8.9 | — |
| PRIMARY Percentage of Subjects Who Converted Impaired Glucose Tolerance (IGT) to Normal Glucose Tolerance (NGT) |
58; 44 | — |
| PRIMARY Mean Percent Change From Baseline in Hepatic Fat Fraction (HFF) |
2.7; 81 | — |
| SECONDARY Mean Percent Change From Baseline in Adiponectin |
79.3; 19.8 | — |
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.
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 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.
Data sourced from ClinicalTrials.gov (NCT00413335). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.