Effect of Rosiglitazone in Nondiabetic Patients With the Metabolic Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00364221
Recruitment Status : Completed
First Posted : August 15, 2006
Last Update Posted : November 22, 2012
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Insulin Resistance Drug: Rosiglitazone Phase 4

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The Effect of Rosiglitazone on Adipocyte-derived Cytokines in Nondiabetics With the Metabolic Syndrome
Study Start Date : November 2004
Actual Primary Completion Date : July 2006
Actual Study Completion Date : October 2006

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00364221

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
Principal Investigator: Christina L Aquilante, PharmD University of Colorado, Denver

Responsible Party: University of Colorado, Denver Identifier: NCT00364221     History of Changes
Other Study ID Numbers: 04-0447
First Posted: August 15, 2006    Key Record Dates
Last Update Posted: November 22, 2012
Last Verified: November 2012

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases
Hypoglycemic Agents
Physiological Effects of Drugs