Impact of Statin Therapy on Muscle Mitochondrial Function and Aerobic Capacity

University of Kansas

Status and phase: Completed; Phase 4

Conditions: Mitochondrial Diseases

Treatments: Drug: Lipitor 20Mg Tablet; Drug: Placebo Oral Tablet; Drug: Lipitor 80Mg Tablet

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03351998

STUDY00140789

R01AR071263 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Enrollment: 68 patients

Sex: All

Ages: 35 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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68 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants receiving matching placebo oral tablet.

Treatment:

Drug: Placebo Oral Tablet

Low dose statin

Active Comparator group

Description:

Participants will receive Lipitor 20Mg Tablet to take daily.

Treatment:

Drug: Lipitor 20Mg Tablet

High dose statin

Active Comparator group

Description:

Participants will receive Lipitor 80Mg Tablet to take daily.

Treatment:

Drug: Lipitor 80Mg Tablet