Effect of Rosiglitazone in Nondiabetic Patients With the Metabolic Syndrome

This study is ongoing, but not recruiting participants.

First Received: August 14, 2006 Last Updated: October 4, 2006 History of Changes

Sponsor:	University of Colorado, Denver
Information provided by:	University of Colorado, Denver
ClinicalTrials.gov Identifier:	NCT00364221

Purpose

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.

Condition	Intervention	Phase
Metabolic Syndrome Insulin Resistance	Drug: Rosiglitazone	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	The Effect of Rosiglitazone on Adipocyte-Derived Cytokines in Nondiabetics With the Metabolic Syndrome

Resource links provided by NLM:

Drug Information available for: Rosiglitazone Rosiglitazone Maleate

U.S. FDA Resources

Eligibility

Ages Eligible for Study:	30 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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,

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00364221

Locations

United States, Colorado
University of Colorado at Denver and Health Sciences Center General Clinical Research Center
Denver, Colorado, United States, 80262

Sponsors and Collaborators

University of Colorado, Denver

Investigators

Principal Investigator:

Christina L Aquilante, PharmD

University of Colorado, Denver

More Information

No publications provided

Study ID Numbers:	COMIRB 04-0447
Study First Received:	August 14, 2006
Last Updated:	October 4, 2006
ClinicalTrials.gov Identifier:	NCT00364221 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Hyperinsulinism
Hypoglycemic Agents
Pathologic Processes
Disease
Metabolic Diseases
Syndrome

Physiological Effects of Drugs
Insulin Resistance
Glucose Metabolism Disorders
Rosiglitazone
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010