Status:
COMPLETED
Impact of Statin Therapy on Adaptations to Aerobic Exercise
Lead Sponsor:
University of Kansas Medical Center
Collaborating Sponsors:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions:
Cardiovascular Diseases
Eligibility:
All Genders
35-65 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine how different doses of a statin affect muscle health and exercise.
Detailed Description
High cholesterol and cardiovascular disease (CVD) is currently prevented and treated with statin therapy. Statin use can cause muscle weakness, fatigue and/or pain, and these symptoms can increase wit...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 5 2024
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT03360916
Start Date
February 1 2018
End Date
June 5 2024
Last Update
April 15 2025
Active Locations (1)
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1
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160