Impact of Statin Therapy on Muscle Mitochondrial Function and Aerobic Capacity

Purpose

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

Condition

  • Mitochondrial Diseases

Eligibility

Eligible Ages
Between 35 Years and 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Placebo 		Participants receiving matching placebo oral tablet.
  • Drug: Placebo Oral Tablet
    Matching placebo pill.
    Other names:
    • Placebo
Active Comparator
Low dose statin 		Participants will receive Lipitor 20Mg Tablet to take daily.
  • Drug: Lipitor 20Mg Tablet
    20 mg/day pills.
    Other names:
    • atorvastatin
Active Comparator
High dose statin 		Participants will receive Lipitor 80Mg Tablet to take daily.
  • Drug: Lipitor 80Mg Tablet
    80 mg/day pills.
    Other names:
    • atorvastatin

More Details

Status
Completed
Sponsor
University of Kansas Medical Center

Study Contact