Impact of Statin Therapy on Adaptations to Aerobic Exercise

Phase 4

Completed

Interventions: Drug: Lipitor 20Mg Tablet
Drug: Lipitor 80Mg Tablet
Drug: Placebo
Behavioral: Exercise Program

Brief Summary: The purpose of this study is to determine how different doses of a statin affect muscle health and exercise.

Detailed Description: High cholesterol and cardiovascular disease (CVD) is currently prevented and treated with statin therapy. Statin use can cause muscle weakness, fatigue and/or pain, and these symptoms can increase with dose and duration of statin use. Statins may also change the ability to exercise.

This study is testing how different doses of a statin, Lipitor, affect muscle health and exercise. The doses that will be used in this study (20 mg/day or 80 mg/day) are typical for treating high cholesterol.

This study is expected to last about 14 weeks.

Recruitment & Eligibility

Inclusion Criteria

Body Mass Index (BMI) between 25-43 kg^m2
Sedentary (less than 150 min of physical activity/week during last 6 months)
Weight stable (no more than 5% change in body weight the previous 3 months)
- >5% risk for a cardiovascular event in the next 10 years according to the 2013 American College of Cardiology/American Heart Association risk calculator and/or 2 out of 5 metabolic syndrome risk factors(Triglycerides ≥ 150 mg/dL; HDL ≤ 40 mg/dL; Glucose ≥ 100mg/dL; Waist Circumference ≥ 102cm for males, 88cm for females; Blood pressure: ≥ 130mmHg systolic and/or 85mmHg diastolic or being treated for hypertension).
Stable doses of medications for 90 days
Willing to stop all Nonsteroidal Antiinflammatory Drugs (NSAIDs) and aspirin for 7 days prior to muscle biopsy

Exclusion Criteria

Smoking
Use of statins in the last 6 months
Use of other medications or supplements that affect lipid profiles or body weight in the last 6 months (e.g., fibric acids, bile acid sequestrants, nicotinic acids, fish oil)
Diagnosis of chronic diseases including CVD, diabetes, other metabolic diseases (e.g., thyroid), cancer, HIV, or acquired immunodeficiency syndrome
History of abnormal bleeding problems
Currently taking (within the last 10 days) anti-platelet medication (Plavix), Warfarin, and other anti-coagulants (eliquis, pradaxa, and xarelto) medications
>2 fold upper normal limit (UNL) for alanine aminotransferase (ALT) or creatinine
Women who are pregnant or breastfeeding
Individuals with polymorphisms known to be associated with susceptibility for statin induced myopathies (tested at screening)
Currently enrolled in another research study

Arm && Interventions

Group	Intervention	Description
Low Statin & Exercise Group	Lipitor 20Mg Tablet	Participants randomized to this group will undergo low statin treatment (Lipitor 20Mg Tablet) and an aerobic exercise program.
High Statin & Exercise Group	Lipitor 80Mg Tablet	Participants randomized to this group will undergo high statin treatment (Lipitor 80Mg Tablet) and an aerobic exercise program.
Placebo & Exercise Group	Placebo	Participants randomized to this group will undergo placebo treatment and an aerobic exercise program.
Placebo & Exercise Group	Exercise Program	Participants randomized to this group will undergo placebo treatment and an aerobic exercise program.
Low Statin & Exercise Group	Exercise Program	Participants randomized to this group will undergo low statin treatment (Lipitor 20Mg Tablet) and an aerobic exercise program.
High Statin & Exercise Group	Exercise Program	Participants randomized to this group will undergo high statin treatment (Lipitor 80Mg Tablet) and an aerobic exercise program.