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
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: The Effect of Rosiglitazone on Adipocyte-derived Cytokines in Nondiabetics With the Metabolic Syndrome

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Study Start Date: November 2004
Study Completion Date: October 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00364221     History of Changes
Other Study ID Numbers: 04-0447
Study First Received: August 14, 2006
Last Updated: November 20, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 21, 2014