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

NCT00413335 | Completed Results

• 1 other identifier: 0508000532
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Impaired Glucose Tolerance; Type 2 Diabetes Mellitus

Keywords

Childhood and Adolescent Obesity; Metabolic phenotype; Impaired Glucose Tolerance; Type 2 Diabetes Mellitus; Insulin Sensitivity; Insulin Resistance; Abdominal fat partitioning; Impaired Glucose Tolerance (IGT); Type 2 Diabetes Mellitus (T2DM)

Outcome Measures

Primary Outcomes (4)

• Mean Percent Change From Baseline in Whole-body Insulin Sensitivity

  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).

  4 months

• Mean Percent Change in Visceral-to-subcutaneous Abdominal Fat

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

  4 months

• Percentage of Subjects Who Converted Impaired Glucose Tolerance (IGT) to Normal Glucose Tolerance (NGT)

  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.

  4 months

• Mean Percent Change From Baseline in Hepatic Fat Fraction (HFF)

  It refers to the percent changes of hepatic fat content.

  4 months

Secondary Outcomes (1)

• Mean Percent Change From Baseline in Adiponectin

  4 months

Study Arms (2)

1

ACTIVE COMPARATOR

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.

Drug: Rosiglitazone

2

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Rosiglitazone DRUG

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

Also known as: Avandia

1

Placebo DRUG

Subject receives placebo.

2

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Good general health
• Aged 10 to 18 yrs (females: Tanner stage II-V;and males:testes size\>6ml)
• IGT based on 2-hr plasma glucose\>140mg/dl and \<200mg/dl during an OGTT.

You may not qualify if:

• Baseline creatinine\>1.0mg
• AST and ALT\>2.5 ULN
• Anemia (Hct\<30)
• Pregnancy (females must have a negative urine pregnancy test during the study)
• Cardiac or pulmonary or other significant chronic illness
• Plans to increase the frequency or intensity of a regular exercise program
• Psychiatric disorder or substance abuse of anorexic agents.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale School of Medicine

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Obesity; Glucose Intolerance; Diabetes Mellitus, Type 2; Pediatric Obesity; Insulin Resistance

Interventions

Rosiglitazone

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Sonia Caprio, Principal Investigator
• Organization: Yale University School of Medicine

Sonia.Caprio@yale.edu

203-785-5692

Study Officials

• Sonia Caprio, MD

  Yale School of Medicine Department of Pediatric Endocrinology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 15, 2006
• First Posted: December 19, 2006
• Study Start: November 1, 2005
• Primary Completion: September 1, 2008
• Study Completion: December 1, 2008
• Last Updated: July 22, 2013
• Results First Posted: April 19, 2013

Record last verified: 2013-07

Locations

US (1)