Effect of Rosiglitazone in Nondiabetic Patients With the Metabolic Syndrome

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

University of Colorado, Denver

ClinicalTrials.gov Identifier:

NCT00364221

First received: August 14, 2006

Last updated: November 20, 2012

Last verified: November 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

August 14, 2006

Last Updated Date

November 20, 2012

Start Date ^ICMJE

November 2004

Primary Completion Date

July 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00364221 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

Effect of Rosiglitazone in Nondiabetic Patients With the Metabolic Syndrome

Official Title ^ICMJE

The Effect of Rosiglitazone on Adipocyte-derived Cytokines in Nondiabetics With the Metabolic Syndrome

Brief Summary

The metabolic syndrome is a collection of health risks that includes obesity, high blood pressure, high triglycerides, high blood sugar, low good cholesterol, and resistance to insulin. The purpose of this study is to find out if the medication, rosiglitazone, influences levels of fat cell proteins and alters insulin resistance in nondiabetic persons with the metabolic syndrome. This is an early step to see if a medication, such as rosiglitazone, will be beneficial in people who have the metabolic syndrome.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Metabolic Syndrome
Insulin Resistance

Intervention ^ICMJE

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

Not Provided

Completion Date

October 2006

Primary Completion Date

July 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Nondiabetic subjects with an NCEP/ATP III diagnosis of the metabolic syndrome

Exclusion Criteria:

Statin Medications, liver disease, cardiovascular disease, heart failure, diabetes, chronic kidney disease,

Gender

Both

Ages

30 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00364221

Other Study ID Numbers ^ICMJE

04-0447

Has Data Monitoring Committee

Not Provided

Responsible Party

University of Colorado, Denver

Study Sponsor ^ICMJE

University of Colorado, Denver

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Christina L Aquilante, PharmD

University of Colorado, Denver

Information Provided By

University of Colorado, Denver

Verification Date

November 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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