Impact of Statin Therapy on Muscle Mitochondrial Function and Aerobic Capacity
Status: | Recruiting |
---|---|
Conditions: | Gastrointestinal |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 35 - 65 |
Updated: | 3/13/2019 |
Start Date: | February 22, 2018 |
End Date: | July 1, 2022 |
Contact: | Clara Amat, MS |
Email: | camatfernandez@kumc.edu |
Phone: | 913-945-8834 |
The purpose of this study is to test how different doses of a statin, Lipitor, affect muscle
health and function, and cardiovascular fitness.
health and function, and cardiovascular fitness.
Inclusion Criteria:
- Body mass index (BMI) between 25-43
- 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
- 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
We found this trial at
2
sites
1001 E 5th St
Greenville, North Carolina 27858
Greenville, North Carolina 27858
(252) 328-6131
Principal Investigator: Darrell Neufer, PhD
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