Clinical trial NCT03360916: Impact of Statin Therapy on Adaptations to Aerobic Exercise
Official title: Impact of Statin Therapy on Adaptations to Aerobic Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiovascular Diseases
Keywords: high cholesterol
exercise
statins
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2017-12-04
Enrollment: 52
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 with dose and duration of statin use. Statins may also change the ability to exercise.

This study is testing how different doses of a statin, Lipitor, affect muscle health and exercise. The doses that will be used in this study (20 mg/day or 80 mg/day) are typical for treating high cholesterol.

This study is expected to last about 14 weeks.

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

Primary outcomes:
measure: Difference in Mitochondrial Respiratory Function
timeFrame: Value at 3 months minus value at baseline
Secondary outcomes:
measure: Change in VO2 Max
timeFrame: Value at 12 months minus value at baseline
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: John Thyfault, PhD
role: PRINCIPAL_INVESTIGATOR
References: