Status:
COMPLETED
Effect of Statins on Oxidative Stress and Endothelial Progenitor Cells
Lead Sponsor:
Emory University
Conditions:
Diabetes Mellitus
Metabolic Syndrome X
Eligibility:
All Genders
21-80 years
Phase:
PHASE2
Brief Summary
Thirty-six subjects with hyperlipidemia and metabolic syndrome and/or diabetes were randomized in a double-blind manner to either pravastatin 80 mg or atorvastatin 10 mg daily. Oxidative stress (dROMs...
Detailed Description
Individuals with a high cholesterol level, diabetes or metabolic syndrome (collection of abnormalities such as high blood pressure, high triglyceride levels \[fat\], obesity, high blood glucose level)...
Eligibility Criteria
Inclusion
- Males or females without child bearing potential aged 21-80 years
- Fasting low-density lipoprotein (LDL) level \> 120mg/dL.
- Either known to be diabetic or have at least 3 components of metabolic syndrome that are defined below:
- Hypertension defined as blood pressure (BP) \> 140 systolic or \> 90 mmHg diastolic, or stable medical therapy for documented hypertension;
- Fasting glucose \> 110 mg/dL;
- Waist \> 40 inches in males, and \> 35 inches in females;
- Triglycerides \> 150mg/dL; or
- High-density lipoprotein (HDL) cholesterol \< 40 mg/dL in males and \< 50 mg/dL in females.
- Able to provide written informed consent
- Non-smoker
Exclusion
- On any oral antioxidants or lipid lowering medications in the previous 8 weeks
- Age \< 21 or \> 80 years
- Premenopausal females with potential for pregnancy
- LDL cholesterol level \< 120 mg/dl
- Initiation or change in dose of any concomitant medical therapy within 2 months before the study
- Uncontrolled hypertension with BP \> 180 mmHg systolic and \> 120 mmHg diastolic
- Current smoker
- Previous intolerance or allergy to statins
- Acute infection in previous 4 weeks
- History of substance abuse
- Uninterpretable Brachial Artery Reactivity Study
- Current neoplasm
- Chronic renal failure (creatinine \> 2.5 mg/dL) or liver failure (liver enzymes \> 2X normal)
- Acute coronary syndrome, heart failure, cerebrovascular accident (CVA), or coronary intervention within 3 months
- Known aortic stenosis, hypertrophic cardiomyopathy, or symptomatic heart failure.
- Inability to give informed consent
- Inability to return to Emory for follow-up
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00166036
Start Date
September 1 2004
End Date
April 1 2009
Last Update
September 8 2014
Active Locations (1)
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1
Emory University Hospital
Atlanta, Georgia, United States, 30322