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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00364221
Other study ID # 04-0447
Secondary ID
Status Completed
Phase Phase 4
First received August 14, 2006
Last updated November 20, 2012
Start date November 2004
Est. completion date October 2006

Study information

Verified date November 2012
Source University of Colorado, Denver
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date October 2006
Est. primary completion date July 2006
Accepts healthy volunteers No
Gender Both
Age group 30 Years to 55 Years
Eligibility 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,

Study Design

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


Intervention

Drug:
Rosiglitazone


Locations

Country Name City State
United States University of Colorado at Denver and Health Sciences Center General Clinical Research Center Denver Colorado

Sponsors (1)

Lead Sponsor Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

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