Phase 4
N=68
Impact of Statin Therapy on Muscle Mitochondrial Function and Aerobic Capacity
Mitochondrial Diseases
Bottom Line
View on ClinicalTrials.gov: NCT03351998 ↗Enrolled (actual)
68
Serious AEs
1.5%
Results posted
Dec 2024
Primary outcome: Primary: Difference in Mitochondrial Respiratory Function — 36; 32; -3 pmols/s/mg — p=0.6051
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Lipitor 20Mg Tablet (Drug); Lipitor 80Mg Tablet (Drug); Placebo Oral Tablet (Drug)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- All
- Sponsor
- University of Kansas Medical Center
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference in Mitochondrial Respiratory Function |
36; 32; -3 | 0.6051 |
| SECONDARY Change in VO2 Max |
-0.2; 0.03; -0.06 | 0.7458 |
Summary
The purpose of this study is to test how different doses of a statin, Lipitor, affect muscle health and function, and cardiovascular fitness.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03351998). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.