Impact of Statin Therapy on Muscle Mitochondrial Function and Aerobic Capacity

The purpose of this study is to test how different doses of a statin, Lipitor, affect muscle
health and function, and cardiovascular fitness.

Eligibility Criteria

Inclusion Criteria:

- Body mass index (BMI) between 30-39

- Sedentary (less than 30 min of physical activity/week during last 6 months and less
than 7,500 steps/day measures by pedometer at baseline)

- 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

- 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 cardiovascular disease, 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 (SLCO1B1 and GATM) known to be associated with
susceptibility for statin induced myopathies (tested at screening)

- Currently enrolled in another research study
 

Principal Investigator

John Thyfault, PhD

Study Contact

Clara Amat Fernandez, camatfernandez@kumc.edu, 913-945-7672

Estimated Completion Date

Friday, April 16, 2021

ClinicalTrials.gov #

NCT03351998
04/10/2018