A Study for Pre-diabetic Patients With Cholesterol Lowering Drugs (SIROCO)

The University of Chicago

Status and phase

Completed

Phase 3

Phase 2

Conditions

Pre-diabetes

Treatments

Drug: Simvastatin

Drug: Placebo Rosiglitazone

Drug: Rosiglitazone

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00831129

14863B (SIROCO)

Details and patient eligibility

About

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.

Full 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

Enrollment

53 patients

Sex

All

Ages

21 to 75 years old

Volunteers

Accepts Healthy Volunteers

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