Phase 2 N=36 Randomized Quadruple-blind Treatment

Effect of Statins on Oxidative Stress and Endothelial Progenitor Cells

Diabetes Mellitus · Metabolic Syndrome X · Hypercholesterolemia

Bottom Line

View on ClinicalTrials.gov: NCT00166036 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2014

Primary outcome: Primary: Change in Plasma Thiobarbituric Acid Reactive Substance (TBARS) Levels — 2.1; 2.5 nmol/mL

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Atorvastatin (Drug); Pravastatin (Drug)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Emory University
Primary completion: Mar 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Plasma Thiobarbituric Acid Reactive Substance (TBARS) Levels	2.1; 2.5	—
SECONDARY Change in Flow-mediated Dilatation (FMD)	5.9; 6.0	—

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 80 years
Premenopausal females with potential for pregnancy
LDL cholesterol level 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00166036). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.