A Study for Pre-diabetic Patients With Cholesterol Lowering Drugs

• Status: Completed
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Chicago
• Collaborator: GlaxoSmithKline
• Treatments: Rosiglitazone; Simvastatin

Criteria

Inclusion Criteria:

• 21-75 years

• Metabolic syndrome (3 of the 5 components)

• Elevated waist circumference >40inches in men, >35inches in women

• Elevated triglycerides >150mg/dL

• Reduced HDL <40mg/dL in men, <50mg/dL in women

• Elevated blood pressure >130mmHg systolic, >85mmHg diastolic

• Elevated fasting glucose >100mg/dL

Exclusion Criteria:

• Diabetes mellitus

• Stage 3 hypertension >180mmHg systolic, >110mmHg diastolic office blood pressure

• History of non-diabetic kidney disease

• Myocardial infarction of unstable angina within the past 6 months

• History of liver disease

• History of malignancy

• History of drug or alcohol abuse

• Treatment with corticosteroids

• Pregnancy or lactating women of women of child bearing potential who are not willing to use reliable contraception method during the study