A Clinical Trial to Prevent the Complications of Insulin Resistance (Including Type-2 Diabetes)

This study has been completed.

First Received on April 24, 2001. Last Updated on June 23, 2005 History of Changes

Sponsor:	National Center for Research Resources (NCRR)
Information provided by:	National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:	NCT00015626

Purpose

The goal of this study is to aggressively treat insulin resistance and its clinical manifestations when they first appear in childhood, and to prevent the subsequent progression towards impaired glucose tolerance and type-2 diabetes. In the process of this clinical trial, we will learn more about the early manifestations of insulin resistance, its treatment, and its relationship to obesity and type-2 diabetes through parallel in-vivo and in-vitro studies.

Condition	Intervention	Phase
Insulin Resistance Diabetes Mellitus	Drug: Metformin Procedure: skin biopsy Behavioral: diet and exercise Drug: pioglitazone Drug: rosiglitazone	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Clinical Trial to Prevent the Complications of Insulin Resistance (Including Type-2 Diabetes)

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

Drug Information available for: Insulin Pioglitazone Pioglitazone hydrochloride Rosiglitazone Rosiglitazone Maleate Metformin Metformin hydrochloride

U.S. FDA Resources

Further study details as provided by National Center for Research Resources (NCRR):

Estimated Enrollment:

300

Eligibility

Ages Eligible for Study:	5 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Obese patients (wt > 95th percentile for age, for adults increased BMI > 27) greater than 5 years of age
And/or presence of complications of insulin resistance such as acanthosis nigricans, dyslipidemia, elevated blood pressure, hyperandrogenism
Siblings and parents of patients with insulin resistance. Siblings and parents will be included only in the case of documented insulin resistance in the index subject. Insulin resistance will be documented by OGTT and/or IVGTT.
Family history of type II diabetes.

Exclusion Criteria:

Critically ill patients, patients will congestive heart failure, renal or liver insufficiency
Inability to give consent.
History of poor compliance with physician's recommendations

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00015626

Locations

United States, New York
Cornell University
New York, New York, United States, 10021

Sponsors and Collaborators

National Center for Research Resources (NCRR)

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00015626 History of Changes
Other Study ID Numbers:	NCRR-M01RR06020-0057
Study First Received:	April 24, 2001
Last Updated:	June 23, 2005
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism

Pioglitazone
Rosiglitazone
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012