NCT00831129

A Study for Pre-diabetic Patients With Cholesterol Lowering Drugs

Effects of Simvastatin and Rosiglitazone Combination in Patients With the Metabolic Syndrome.

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The purpose of this research study is to examine if a combination of a cholesterol lowering-drug, simvastatin, with a sugar-lowering drug called rosiglitazone is more effective in improving vascular inflammation (irritation of the vessels that transport your blood) and other cardiovascular risk factors than the taking of simvastatin alone.

Detailed description

Age 21-75 years Metabolic syndrome (must have 3 of the 5 components) elevated waist circumference \>40inches in men, \>35 inches in women elevated triglycerides \>150mg/dL reduced HDL \<40mg/dL in men\<50 in women elevated blood pressure \>130mmHg systolic, or \>85mmHg diastolic elevated fasting glucose \>100mg/dL

Conditions

• Pre-diabetes

Interventions

Type	Name	Description
DRUG	Rosiglitazone	4 mg daily
DRUG	Placebo Rosiglitazone	1 tab daily
DRUG	Simvastatin	40 mg daily

Timeline

• Start date: 2006-09-01
• Primary completion: 2011-03-01
• Completion: 2011-04-01
• First posted: 2009-01-28
• Last updated: 2017-02-10
• Results posted: 2013-09-12

Locations

1 site across 1 country: United States