Impact of Statin Therapy on Muscle Mitochondrial Function and Aerobic Capacity

Phase 4

Completed

• Conditions: Mitochondrial Diseases
• Interventions: Drug: Placebo Oral Tablet; Drug: Lipitor 80Mg Tablet; Drug: Lipitor 20Mg Tablet

• Registration Number: NCT03351998
• Lead Sponsor: University of Kansas Medical Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-20
• Study First Submitted QC: 2017-11-20
• Study First Posted: 2017-11-24
• Study Start: 2018-02-22
• Primary Completion: 2023-07-07
• Study Completion: 2023-07-07
• Results First Submitted: 2024-10-16
• Status Verified: 2024-11
• Results First Submitted QC: 2024-11-25
• Last Update Submitted: 2024-11-25
• Results First Posted: 2024-12-18
• Last Update Posted: 2024-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo Oral Tablet	Participants receiving matching placebo oral tablet.
High dose statin	Lipitor 80Mg Tablet	Participants will receive Lipitor 80Mg Tablet to take daily.
Low dose statin	Lipitor 20Mg Tablet	Participants will receive Lipitor 20Mg Tablet to take daily.

Primary Outcome Measures

Name	Time	Method
Difference in Mitochondrial Respiratory Function	value at 12 months minus value at baseline

Secondary Outcome Measures

Name	Time	Method
Change in VO2 Max	value at 12 months minus value at baseline

Trial Locations

Locations (2)

East Carolina University; 🇺🇸 Greenville, North Carolina, United States

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States