A Study for Pre-diabetic Patients With Cholesterol Lowering Drugs

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Pre-diabetes

Intervention / Treatment
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* Drug: Rosiglitazone
* Drug: Placebo Rosiglitazone
* Drug: Simvastatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Simvastatin + Placebo Rosiglitazone<br>Subjects will receive 40 mg Simvastatin + 1 tab Placebo Rosiglitazone daily | Drug: Placebo Rosiglitazone<br>* 1 tab daily<br>* Other names: Placebo;Drug: Simvastatin<br>* 40 mg daily<br>* Other names: Zocor;|
| Active Comparator: Simvastatin + rosiglitazone<br>Subjects will receive 40 mg Simvastatin + 4 mg Rosiglitazone once daily | Drug: Rosiglitazone<br>* 4 mg daily<br>* Other names: Avandia;Drug: Simvastatin<br>* 40 mg daily<br>* Other names: Zocor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in High-sensitivity C-reactive Protein | change in high-sensitivity C-reactive between baseline and 6 month | Baseline and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Urinary Isoprostane | change in urinary isoprostane between baseline and 6 month | Baseline and 6 months | 
| Change in Malondialdehyde | change in Malondialdehyde between baseline and 6 month | Baseline and 6 months | 
| Change in Office Systolic Blood Pressure | change in office systolic blood pressure between baseline and 6 month | Baseline and 6 months | 
| Change in Office Diastolic Blood Pressure | change in office diastolic blood pressure between baseline and 6 month | Baseline and 6 months | 
| Change in (Ambulatory Blood Pressure Monitoring) Systolic Blood Pressure | change in (ambulatory blood pressure monitoring) systolic blood pressure between baseline and 6 month | Baseline and 6 months | 
| Change in (Ambulatory Blood Pressure Monitoring) Diastolic Blood Pressure | change in (ambulatory blood pressure monitoring) diastolic blood pressure between baseline and 6 month | Baseline and 6 months | 
| Change in Low-density Lipoprotein | change in low-density lipoprotein between baseline and 6 month | Baseline and 6 months | 
| Change in Triglycerides | change in Triglycerides between baseline and 6 month | Baseline and 6 months | 
| Change in High-density Lipoprotein | change in high-density lipoprotein between baseline and 6 month | Baseline and 6 months | 
| Change in Glycosylated Haemoglobin | change in glycosylated haemoglobin between baseline and 6 month | Baseline and 6 months | 
| Change in Fasting Blood Glucose | change in fasting blood glucose between baseline and 6 month | Baseline and 6 months | 
| Change in Insulin | change in Insulin between baseline and 6 month | Baseline and 6 months | 
| Change in Homeostatic Model Assessment for Insulin Resistance | change in homeostatic model assessment for insulin resistance between baseline and 6 month | Baseline and 6 months | 
| Change in Adiponectin | change in Adiponectin between baseline and 6 month | Baseline and 6 months | 
| Change in Body Mass Index | change in body mass index between baseline and 6 month | Baseline and 6 months |