A Study for Pre-diabetic Patients With Cholesterol Lowering Drugs

University of Chicago53 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

Conditions

Pre-diabetes

Interventions

RosiglitazoneDRUG

4 mg daily

Placebo RosiglitazoneDRUG

1 tab daily

SimvastatinDRUG

40 mg daily

Eligibility

Sex: ALLMin age: 21 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Chicago

Chicago, Illinois, United States