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

This study has been completed.

Sponsor:

Information provided by:

National Center for Research Resources (NCRR)

ClinicalTrials.gov Identifier:

NCT00015626

First received: April 24, 2001

Last updated: June 23, 2005

Last verified: December 2003

History of Changes

Tracking Information
First Received Date ^ICMJE	April 24, 2001
Last Updated Date	June 23, 2005
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00015626 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Clinical Trial to Prevent the Complications of Insulin Resistance (Including Type-2 Diabetes)
Official Title ^ICMJE	A Clinical Trial to Prevent the Complications of Insulin Resistance (Including Type-2 Diabetes)
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Insulin Resistance Diabetes Mellitus
Intervention ^ICMJE	Drug: Metformin Procedure: skin biopsy Behavioral: diet and exercise Drug: pioglitazone Drug: rosiglitazone
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	300
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	5 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00015626
Other Study ID Numbers ^ICMJE	NCRR-M01RR06020-0057
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	National Center for Research Resources (NCRR)
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	National Center for Research Resources (NCRR)
Verification Date	December 2003
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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