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

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The purpose of this study is to test how different doses of a statin, Lipitor, affect muscle
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
3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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1001 E 5th St
Greenville, North Carolina 27858
(252) 328-6131
Principal Investigator: Darrell Neufer, PhD
East Carolina University Whether it's meeting the demand for more teachers and healthcare professionals or...
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Greenville, NC
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