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Sponsored by: |
Yale University |
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Information provided by: | Yale University |
ClinicalTrials.gov Identifier: | NCT00413335 |
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.
Condition | Intervention |
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Obesity Impaired Glucose Tolerance Type 2 Diabetes Mellitus |
Drug: Rosiglitazone Drug: Placebo |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Effects of Rosiglitazone on the Metabolic Phenotype of Impaired Glucose Tolerance in Youth |
Estimated Enrollment: | 62 |
Study Start Date: | November 2005 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Subject receives Rosiglitazone.
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Drug: Rosiglitazone
2mg to begin then 4mg, twice daily for 4 months
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2: Placebo Comparator
Subject receives placebo
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Drug: Placebo
Subject receives placebo.
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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. We 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, we 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.
Ages Eligible for Study: | 10 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Sonia Caprio, MD | 203-785-5692 | sonia.caprio@yale.edu |
United States, Connecticut | |
Yale School of Medicine | Recruiting |
New Haven, Connecticut, United States, 06520 | |
Contact: Sonia Caprio, MD 203-785-5692 sonia.caprio@yale.edu | |
Principal Investigator: Sonia Caprio, MD |
Principal Investigator: | Sonia Caprio, MD | Yale School of Medicine Department of Pediatric Endocrinology |
Responsible Party: | Yale University ( Sonia Caprio, MD/Professor of Pediatrics ) |
Study ID Numbers: | 0508000532 |
Study First Received: | December 15, 2006 |
Last Updated: | June 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00413335 History of Changes |
Health Authority: | United States: Institutional Review Board |
Childhood and Adolescent Obesity Metabolic phenotype Impaired Glucose Tolerance Type 2 Diabetes Mellitus Insulin Sensitivity |
Insulin Resistance Abdominal fat partitioning Childhood and Adolescent Obesity Impaired Glucose Tolerance (IGT) Type 2 Diabetes Mellitus (T2DM) |
Obesity Metabolic Diseases Glucose Intolerance Diabetes Mellitus Endocrine System Diseases Overweight Insulin Body Weight Signs and Symptoms Hypoglycemic Agents |
Hyperglycemia Diabetes Mellitus, Type 2 Nutrition Disorders Overnutrition Endocrinopathy Insulin Resistance Glucose Metabolism Disorders Rosiglitazone Metabolic Disorder |
Obesity Metabolic Diseases Physiological Effects of Drugs Glucose Intolerance Diabetes Mellitus Endocrine System Diseases Overweight Pharmacologic Actions Body Weight |
Signs and Symptoms Hypoglycemic Agents Hyperglycemia Diabetes Mellitus, Type 2 Nutrition Disorders Overnutrition Glucose Metabolism Disorders Rosiglitazone |