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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sonia Caprio, Yale University
ClinicalTrials.gov Identifier:
NCT00413335
First received: December 15, 2006
Last updated: July 15, 2013
Last verified: July 2013
Results First Received: November 7, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Obesity
Impaired Glucose Tolerance
Type 2 Diabetes Mellitus
Interventions: Drug: Rosiglitazone
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited from a multi-ethnic cohort of obese children and adolescents drawn from the Pediatric Obesity Clinic at Yale-New Haven Hospital.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Obese children and adolescents with positive risk factors for Type 2 Diabetes (T2DM) were screened by using a standard oral glucose tolerance test (OCTT).

Reporting Groups
  Description
Active Arm (Rosiglitazone)

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.

Rosiglitazone : 2mg to begin then 4mg, twice daily for 4 months

Inactive Arm (Placebo)

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.

Placebo : Subject receives placebo.


Participant Flow:   Overall Study
    Active Arm (Rosiglitazone)     Inactive Arm (Placebo)  
STARTED     12     9  
COMPLETED     12     9  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Active Arm (Rosiglitazone)

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.

Rosiglitazone : 2mg to begin then 4mg, twice daily for 4 months

Inactive Arm (Placebo)

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.

Placebo : Subject receives placebo.

Total Total of all reporting groups

Baseline Measures
    Active Arm (Rosiglitazone)     Inactive Arm (Placebo)     Total  
Number of Participants  
[units: participants]
  12     9     21  
Age  
[units: years]
Mean ± Standard Deviation
  12.8  ± 1.6     13.9  ± 2.0     13.0  ± 2.0  
Gender  
[units: participants]
     
Female     7     5     12  
Male     5     4     9  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Percent Change From Baseline in Whole-body Insulin Sensitivity   [ Time Frame: 4 months ]

2.  Primary:   Mean Percent Change in Visceral-to-subcutaneous Abdominal Fat   [ Time Frame: 4 months ]

3.  Primary:   Percentage of Subjects Who Converted Impaired Glucose Tolerance (IGT) to Normal Glucose Tolerance (NGT)   [ Time Frame: 4 months ]

4.  Primary:   Mean Percent Change From Baseline in Hepatic Fat Fraction (HFF)   [ Time Frame: 4 months ]

5.  Secondary:   Mean Percent Change From Baseline in Adiponectin   [ Time Frame: 4 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Sonia Caprio, Principal Investigator
Organization: Yale University School of Medicine
phone: 203-785-5692
e-mail: Sonia.Caprio@yale.edu


No publications provided


Responsible Party: Sonia Caprio, Yale University
ClinicalTrials.gov Identifier: NCT00413335     History of Changes
Other Study ID Numbers: 0508000532
Study First Received: December 15, 2006
Results First Received: November 7, 2012
Last Updated: July 15, 2013
Health Authority: United States: Institutional Review Board