Back to resultsEffect of Rosiglitazone in Nondiabetic Patients With the Metabolic Syndrome
Primary Purpose
Metabolic Syndrome, Insulin Resistance
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Rosiglitazone
Sponsored by
About this trial
This is an interventional treatment trial for Metabolic Syndrome
Eligibility 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,
Sites / Locations
- University of Colorado at Denver and Health Sciences Center General Clinical Research Center
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00364221
First Posted
August 14, 2006
Last Updated
November 20, 2012
Sponsor
University of Colorado, Denver
1. Study Identification
Unique Protocol Identification Number
NCT00364221
Brief Title
Effect of Rosiglitazone in Nondiabetic Patients With the Metabolic Syndrome
Official Title
The Effect of Rosiglitazone on Adipocyte-derived Cytokines in Nondiabetics With the Metabolic Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
October 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Insulin Resistance
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Rosiglitazone
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina L Aquilante, PharmD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado at Denver and Health Sciences Center General Clinical Research Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
12. IPD Sharing Statement
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Effect of Rosiglitazone in Nondiabetic Patients With the Metabolic Syndrome
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