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Purpose

The purpose of this study is to determine how different doses of a statin affect muscle health and exercise.

Condition

Eligibility

Eligible Ages
Between 35 Years and 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Placebo & Exercise Group 		Participants randomized to this group will undergo placebo treatment and an aerobic exercise program.
  • Drug: Placebo
    One matching placebo tablet by mouth every day for 12 weeks.
  • Behavioral: Exercise Program
    Exercise program of brisk walking and/or slow jogging on a treadmill for 90 minutes of exercise spread over 3 days during week 1, 150 minutes of exercise spread over 5 days during week 2, 225 minutes of exercise over 5 days during week 3 and for the rest of the study.
Experimental
Low Statin & Exercise Group 		Participants randomized to this group will undergo low statin treatment (Lipitor 20Mg Tablet) and an aerobic exercise program.
  • Drug: Lipitor 20Mg Tablet
    One tablet by mouth every day for 12 weeks.
    Other names:
    • Atorvastatin
  • Behavioral: Exercise Program
    Exercise program of brisk walking and/or slow jogging on a treadmill for 90 minutes of exercise spread over 3 days during week 1, 150 minutes of exercise spread over 5 days during week 2, 225 minutes of exercise over 5 days during week 3 and for the rest of the study.
Experimental
High Statin & Exercise Group 		Participants randomized to this group will undergo high statin treatment (Lipitor 80Mg Tablet) and an aerobic exercise program.
  • Drug: Lipitor 80Mg Tablet
    One tablet by mouth every day for 12 weeks.
    Other names:
    • Atorvastatin
  • Behavioral: Exercise Program
    Exercise program of brisk walking and/or slow jogging on a treadmill for 90 minutes of exercise spread over 3 days during week 1, 150 minutes of exercise spread over 5 days during week 2, 225 minutes of exercise over 5 days during week 3 and for the rest of the study.

More Details

Status
Active, not recruiting
Sponsor
University of Kansas Medical Center

Study Contact

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.