| Trial ID: | L4040 |
| Source ID: | NCT00413335
|
| Associated Drug: |
Rosiglitazone
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| Title: |
Effects of Rosiglitazone on the Metabolic Phenotype of Impaired Glucose Tolerance in Youth
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| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00413335/results
|
| Conditions: |
Obesity|Impaired Glucose Tolerance|Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Rosiglitazone|DRUG: Placebo
|
| Outcome Measures: |
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|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|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|Mean Percent Change From Baseline in Hepatic Fat Fraction (HFF), It refers to the percent changes of hepatic fat content., 4 months | Secondary: Mean Percent Change From Baseline in Adiponectin, This refers to the changes of adiponectin levels., 4 months
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| Sponsor/Collaborators: |
Sponsor: Yale University
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| Gender: |
ALL
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| Age: |
CHILD, ADULT
|
| Phases: |
|
| Enrollment: |
21
|
| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
|
| Start Date: |
2005-11
|
| Completion Date: |
2008-12
|
| Results First Posted: |
2013-04-19
|
| Last Update Posted: |
2013-07-22
|
| Locations: |
Yale School of Medicine, New Haven, Connecticut, 06520, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00413335
|
