Phase 4
N=52
Impact of Statin Therapy on Adaptations to Aerobic Exercise
Cardiovascular Diseases
Bottom Line
View on ClinicalTrials.gov: NCT03360916 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Difference in Mitochondrial Respiratory Function — 2.29; -11.24; 44.88 pmols/s/mg — p=0.9530
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Lipitor 20Mg Tablet (Drug); Lipitor 80Mg Tablet (Drug); Placebo (Drug); Exercise Program (Behavioral)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- All
- Sponsor
- University of Kansas Medical Center
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference in Mitochondrial Respiratory Function |
2.29; -11.24; 44.88 | 0.9530 |
| SECONDARY Change in VO2 Max |
0.22; 0.23; 0.21 | 0.0005 sig |
Summary
The purpose of this study is to determine how different doses of a statin affect muscle health and exercise.
Eligibility Criteria
Inclusion Criteria
- Body Mass Index (BMI) between 25-43 kg^m2
- Sedentary (less than 150 min of physical activity/week during last 6 months)
- 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).
- 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
- Use of statins in the last 6 months
- 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, diabetes, other metabolic diseases (e.g., thyroid), cancer, HIV, or acquired immunodeficiency syndrome
- 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 known to be associated with susceptibility for statin induced myopathies (tested at screening)
- Currently enrolled in another research study
Data sourced from ClinicalTrials.gov (NCT03360916). 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.