Effect of Statins on Oxidative Stress and Endothelial Progenitor Cells
Condition: Diabetes Mellitus; Metabolic Syndrome X; Hypercholesterolemia
MeSH terms: Metabolic Syndrome; Hypercholesterolemia
Intervention: Atorvastatin; Pravastatin
Intervention description: 12 Weeks of Oral Atorvastatin 10 mg therapy.; 12 Weeks of Oral Pravastatin 80 mg therapy.
Intervention MeSH terms: Atorvastatin; Pravastatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 36.0
Sex: All
Minimum age: 21 Years
Maximum age: 80 Years
Healthy volunteers: No

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 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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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