A Study for Pre-diabetic Patients With Cholesterol Lowering Drugs

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2011-04-30

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.

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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

Conditions

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Pre-diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Simvastatin + Placebo Rosiglitazone

Subjects will receive 40 mg Simvastatin + 1 tab Placebo Rosiglitazone daily

Group Type ACTIVE_COMPARATOR

Placebo Rosiglitazone

Intervention Type DRUG

1 tab daily

Simvastatin

Intervention Type DRUG

40 mg daily

Simvastatin + rosiglitazone

Subjects will receive 40 mg Simvastatin + 4 mg Rosiglitazone once daily

Group Type ACTIVE_COMPARATOR

Rosiglitazone

Intervention Type DRUG

4 mg daily

Simvastatin

Intervention Type DRUG

40 mg daily

Interventions

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Rosiglitazone

4 mg daily

Intervention Type DRUG

Placebo Rosiglitazone

1 tab daily

Intervention Type DRUG

Simvastatin

40 mg daily

Intervention Type DRUG

Other Intervention Names

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Avandia Placebo Zocor

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

Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes