Impact of Statin Therapy on Muscle Mitochondrial Function and Aerobic Capacity

  • STATUS
    Recruiting
  • End date
    Jul 1, 2023
  • participants needed
    120
  • sponsor
    University of Kansas Medical Center
Updated on 10 September 2021
body mass index
muscle biopsy
lipitor
lipitor 20mg tablet

Summary

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

Details
Condition Metabolic disorder, Metabolic Disorders, mitochondrial disorder
Treatment Placebo Oral Tablet, Lipitor 20Mg Tablet, Lipitor 80Mg Tablet
Clinical Study IdentifierNCT03351998
SponsorUniversity of Kansas Medical Center
Last Modified on10 September 2021

Eligibility

Yes No Not Sure

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 (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) and/or LDL-Cholesterol >120 mg/dl
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
Previous use of statins
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, other metabolic diseases (e.g., thyroid), current diagnosis and active treatment of cancer, HIV, or acquired immunodeficiency syndrome
Diagnosis of type 1 or type 2 diabetes at the time of screening (fasting blood glucose >126mg/dL). If evidence of type 2 diabetes outcome measures is detected during the course of the study (fasting glucose > 126 mg/dl or HbA1c > 6.5%) we will notify the participant to contact their physician
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
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