Trial · NCT00413335
Effects of Rosiglitazone on the Metabolic Phenotype of Impaired Glucose Tolerance in Youth
NCT00413335, Not applicable, Completed, Yale University; results first posted 2013-04-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effects of Rosiglitazone on the Metabolic Phenotype of Impaired Glucose Tolerance in Youth. Trials, record NCT00413335. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00413335
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effects of Rosiglitazone on the Metabolic Phenotype of Impaired Glucose Tolerance in Youth
- NCT number
- NCT00413335
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 21 participants, actual
- Lead sponsor
- Yale University
- Conditions
- Obesity, Impaired Glucose Tolerance, Type 2 Diabetes Mellitus
- Interventions
- Rosiglitazone, Placebo
- First posted
- 2006-12-19
- Last updated
- 2013-07-22
- Results first posted
- 2013-04-19
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Percent Change From Baseline in Whole-body Insulin Sensitivity | 4 months | 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). |
| Primary | Mean Percent Change in Visceral-to-subcutaneous Abdominal Fat | 4 months | This describes the percent changes of the ratio between visceral and subcutaneous abdominal fat. |
| Primary | Percentage of Subjects Who Converted Impaired Glucose Tolerance (IGT) to Normal Glucose Tolerance (NGT) | 4 months | 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. |
| Primary | Mean Percent Change From Baseline in Hepatic Fat Fraction (HFF) | 4 months | It refers to the percent changes of hepatic fat content. |
| Secondary | Mean Percent Change From Baseline in Adiponectin | 4 months | This refers to the changes of adiponectin levels. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Percent Change From Baseline in Whole-body Insulin Sensitivity | 4 months | percentage of change from baseline | MEAN | |
| PRIMARY | Mean Percent Change in Visceral-to-subcutaneous Abdominal Fat | 4 months | percentage of change from baseline | MEAN | |
| PRIMARY | Percentage of Subjects Who Converted Impaired Glucose Tolerance (IGT) to Normal Glucose Tolerance (NGT) | 4 months | percentage of participants | NUMBER | |
| SECONDARY | Mean Percent Change From Baseline in Adiponectin | 4 months | percentage of change from baseline | MEAN | |
| PRIMARY | Mean Percent Change From Baseline in Hepatic Fat Fraction (HFF) | 4 months | percentage of change from baseline | MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Percent Change From Baseline in Whole-body Insulin Sensitivity | Active Arm (Rosiglitazone) | 87.4 | Standard Deviation 77.0 | percentage of change from baseline | |
| Mean Percent Change From Baseline in Whole-body Insulin Sensitivity | Inactive Arm (Placebo) | 63.1 | Standard Deviation 61.6 | percentage of change from baseline | |
| Mean Percent Change in Visceral-to-subcutaneous Abdominal Fat | Active Arm (Rosiglitazone) | -7.3 | Standard Deviation 23.1 | percentage of change from baseline | |
| Mean Percent Change in Visceral-to-subcutaneous Abdominal Fat | Inactive Arm (Placebo) | 8.9 | Standard Deviation 22.6 | percentage of change from baseline | |
| Percentage of Subjects Who Converted Impaired Glucose Tolerance (IGT) to Normal Glucose Tolerance (NGT) | Active Arm (Rosiglitazone) | 58 | percentage of participants | ||
| Percentage of Subjects Who Converted Impaired Glucose Tolerance (IGT) to Normal Glucose Tolerance (NGT) | Inactive Arm (Placebo) | 44 | percentage of participants | ||
| Mean Percent Change From Baseline in Adiponectin | Active Arm (Rosiglitazone) | 79.3 | Standard Deviation 78.2 | percentage of change from baseline | |
| Mean Percent Change From Baseline in Adiponectin | Inactive Arm (Placebo) | 19.8 | Standard Deviation 52.8 | percentage of change from baseline | |
| Mean Percent Change From Baseline in Hepatic Fat Fraction (HFF) | Active Arm (Rosiglitazone) | 2.7 | Standard Deviation 107 | percentage of change from baseline | |
| Mean Percent Change From Baseline in Hepatic Fat Fraction (HFF) | Inactive Arm (Placebo) | 81 | Standard Deviation 267 | percentage of change from baseline |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Active Arm (Rosiglitazone) | 12 | |
| Overall Study | STARTED | Inactive Arm (Placebo) | 9 | |
| Overall Study | COMPLETED | Active Arm (Rosiglitazone) | 12 | |
| Overall Study | COMPLETED | Inactive Arm (Placebo) | 9 | |
| Overall Study | NOT COMPLETED | Active Arm (Rosiglitazone) | 0 | |
| Overall Study | NOT COMPLETED | Inactive Arm (Placebo) | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Active Arm (Rosiglitazone) | ||
| Total, all-cause mortality | Inactive Arm (Placebo) | ||
| Total, other adverse events | Active Arm (Rosiglitazone) | 0 | 12 |
| Total, other adverse events | Inactive Arm (Placebo) | 0 | 9 |
| Total, serious adverse events | Active Arm (Rosiglitazone) | 0 | 12 |
| Total, serious adverse events | Inactive Arm (Placebo) | 0 | 9 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Active Arm (Rosiglitazone) vs Inactive Arm (Placebo): serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00413335
GET https://conductscience.org/api/trials/v1/NCT00413335/registered