Effect of Statins on Oxidative Stress and Endothelial Progenitor Cells

Completed · Phase 2

Conditions studied: Diabetes Mellitus, Metabolic Syndrome X, Hypercholesterolemia

In brief

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 assay that measures lipid hydroperoxides, plasma thiobarbituric acid reactive substances \[TBARS\], and aminothiol levels) and brachial artery flow-mediated dilation (FMD) were measured at baseline and after 12 weeks of statin therapy.

Key facts

Study ID

NCT00166036

Run by

Emory University

People needed

36

Starts

2004-09-01

Expected to finish

2009-04-01

Last updated by the study team

2014-09-08

Who can join

Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Emory University Hospital — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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