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Phase 4 N=52 Randomized Double-blind Prevention

Impact of Statin Therapy on Adaptations to Aerobic Exercise

Cardiovascular Diseases

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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