Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00413335
Status:
COMPLETED
Last Update Posted:
2013-07-22
First Post:
2006-12-15
Brief Title:
Effects of Rosiglitazone on the Metabolic Phenotype of Impaired Glucose Tolerance in Youth
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Effects of Rosiglitazone on the Metabolic Phenotype of Impaired Glucose Tolerance in Youth
Status:
COMPLETED
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Impaired Glucose Tolerance IGT is a prelude to diabetes which is increasing in prevalence in obese children and adolescents with marked obesity This condition tends to progress to Type 2 Diabetes Mellitus T2DM at an alarmingly rapid tempo The increased prevalence of childhood and adolescent obesity and greater risk of IGT and progression to diabetes in this population set the stage for a series of studies aimed at understanding the metabolic phenotype and natural history of pre-diabetes in obese youth The investigators found that obese children and adolescents with IGT are characterized by marked insulin resistance related to altered lipid partitioning favoring lipid deposition in the visceral and intramyocellular compartment Furthermore the investigators found an impairment of the acute insulin response in these youngsters Follow-up revealed a rapid deterioration from IGT to frank diabetes Based on these studies there is a strong rationale for changing the balance between visceral and subcutaneous fat and muscle lipid content in a more favorable pattern in order to improve insulin sensitivity
The primary objective of this study is to determine in a group of ethnically diverse children and adolescents with IGT whether treatment with rosiglitazone leads to improvements in insulin sensitivity and glucose tolerance Secondary objectives are to determine whether rosiglitazone is safe and well tolerated
The primary objective of this study is to determine in a group of ethnically diverse children and adolescents with IGT whether treatment with rosiglitazone leads to improvements in insulin sensitivity and glucose tolerance Secondary objectives are to determine whether rosiglitazone is safe and well tolerated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None