Trial Outcomes & Findings for Effects of Rosiglitazone on the Metabolic Phenotype of Impaired Glucose Tolerance in Youth (NCT NCT00413335)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

21 participants

Primary outcome timeframe

4 months

Results posted on

2013-07-22

Participant Flow

Subjects were recruited from a multi-ethnic cohort of obese children and adolescents drawn from the Pediatric Obesity Clinic at Yale-New Haven Hospital.

Obese children and adolescents with positive risk factors for Type 2 Diabetes (T2DM) were screened by using a standard oral glucose tolerance test (OCTT).

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	12	9
Overall Study COMPLETED	12	9
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active Arm (Rosiglitazone) n=12 Participants 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) n=9 Participants 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 n=21 Participants Total of all reporting groups
Age Continuous	12.8 years STANDARD_DEVIATION 1.6 • n=5 Participants	13.9 years STANDARD_DEVIATION 2.0 • n=7 Participants	13.0 years STANDARD_DEVIATION 2.0 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Active Arm (Rosiglitazone) n=12 Participants 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) n=9 Participants 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.
Mean Percent Change From Baseline in Whole-body Insulin Sensitivity	87.4 percentage of change from baseline Standard Deviation 77.0	63.1 percentage of change from baseline Standard Deviation 61.6

PRIMARY outcome

Timeframe: 4 months

This describes the percent changes of the ratio between visceral and subcutaneous abdominal fat.

Outcome measures

Outcome measures
Measure	Active Arm (Rosiglitazone) n=12 Participants 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) n=9 Participants 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.
Mean Percent Change in Visceral-to-subcutaneous Abdominal Fat	-7.3 percentage of change from baseline Standard Deviation 23.1	8.9 percentage of change from baseline Standard Deviation 22.6

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Active Arm (Rosiglitazone) n=12 Participants 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) n=9 Participants 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.
Percentage of Subjects Who Converted Impaired Glucose Tolerance (IGT) to Normal Glucose Tolerance (NGT)	58 percentage of participants	44 percentage of participants

PRIMARY outcome

Timeframe: 4 months

It refers to the percent changes of hepatic fat content.

Outcome measures

Outcome measures
Measure	Active Arm (Rosiglitazone) n=12 Participants 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) n=9 Participants 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.
Mean Percent Change From Baseline in Hepatic Fat Fraction (HFF)	2.7 percentage of change from baseline Standard Deviation 107	81 percentage of change from baseline Standard Deviation 267

SECONDARY outcome

Timeframe: 4 months

This refers to the changes of adiponectin levels.

Outcome measures

Outcome measures
Measure	Active Arm (Rosiglitazone) n=12 Participants 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) n=9 Participants 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.
Mean Percent Change From Baseline in Adiponectin	79.3 percentage of change from baseline Standard Deviation 78.2	19.8 percentage of change from baseline Standard Deviation 52.8

Adverse Events

Active Arm (Rosiglitazone)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Inactive Arm (Placebo)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sonia Caprio, Principal Investigator

Yale University School of Medicine

Phone: 203-785-5692

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place