The purpose of this study is to determine the efficacy of Lipitor (Atorvastatin) for the treatment of PCOS with elevated LDL cholesterol.
The investigators hypothesize that improving the lipid profile with atorvastatin will improve vascular function, increase the frequency of ovulation, decrease androgen levels, improve insulin sensitivity, and improve the lipid profile more efficiently than placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
20
Penn State Milton S Hershey Medical Center, College of Medicine
Hershey, Pennsylvania, United States
Brachial Artery Flow-mediated Dilation (FMD)
Brachial artery FMD, the percent change in brachial artery diameter following release of transient occlusion, was selected as the primary outcome because it is the most widely used research tool for evaluating the effects of interventions on endothelial function. FMD has been shown to predict longterm cardiovascular events, even in patients with no apparent heart disease.
Time frame: baseline and 6 weeks
Peak Brachial Artery Conductance (BAC)
Pneumatic cuffs were positioned on the upper arm and wrist of the experimental arm. The brachial artery was imaged using an ATL Doppler ultrasound probe (5-12MHz linear array scanhead, HDI 5000, Advanced Technology Laboratories, Bothell, WA). Mean blood flow velocity (MBV) and brachial artery diameter (BAD) were recorded at baseline. Then the wrist cuff was inflated to 200-250 mmHg. After a minute, with the wrist cuff still inflated, the arm cuff was inflated to 200-250 mmHg. After 10 minutes the arm cuff was released to induce reactive hyperemia in the brachial artery. Upon release of the arm cuff, we continuously measured blood pressure (BP), heart rate (HR), and MBV, and intermittently measured BAD in the experimental arm. Brachial artery conductance (BAC)was calculated as MBV/MAP and FMD was calculated as percent change in BAD from baseline.
Time frame: baseline and 6 weeks
Total Cholesterol
Time frame: baseline and 6 weeks
LDL Cholesterol
Time frame: baseline and 6 weeks
HDL Cholesterol
Time frame: baseline and 6 weeks
Triglycerides
Time frame: baseline and 6 weeks
Fasting Glucose
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Time frame: baseline and 6 weeks
Fasting Insulin
Time frame: baseline and 6 weeks
Area Under the Curve (AUC) for Glucose During OGTT
A 75 gram oral glucose tolerance test (OGTT) was performed with blood draws at 0, 30, 60, 90 and 120 minutes.
Time frame: baseline and 6 weeks
AUC for Insulin
Area under the curve for insulin during OGTT: A 75 gram oral glucose tolerance test was performed with blood draws at 0, 30, 60, 90 and 120 minutes.
Time frame: baseline and 6 weeks
Total Testosterone
Time frame: baseline and 6 weeks
Androstenedione
Time frame: baseline and 6 weeks
DHEAS
Dehydroepiandrosterone sulfate
Time frame: baseline and 6 weeks