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

Tracking Information
First Received Date ^ICMJE	April 24, 2001
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00015626 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

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
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study
Condition ^ICMJE	Insulin Resistance Diabetes Mellitus
Intervention ^ICMJE	Drug: Metformin Procedure: skin biopsy Behavioral: diet and exercise Drug: pioglitazone Drug: rosiglitazone
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	300
Completion Date
Primary Completion Date
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 ID ^ICMJE	NCT00015626
Responsible Party
Study ID Numbers ^ICMJE	NCRR-M01RR06020-0057
Study Sponsor ^ICMJE	National Center for Research Resources (NCRR)
Collaborators ^ICMJE
Investigators ^ICMJE
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