Impact of Statin Therapy on Adaptations to Aerobic Exercise

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-01

Study Completion Date

2024-06-05

Brief Summary

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

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Detailed Description

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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.

Conditions

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Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo & Exercise Group

Participants randomized to this group will undergo placebo treatment and an aerobic exercise program.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

One matching placebo tablet by mouth every day for 12 weeks.

Exercise Program

Intervention Type BEHAVIORAL

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.

Low Statin & Exercise Group

Participants randomized to this group will undergo low statin treatment (Lipitor 20Mg Tablet) and an aerobic exercise program.

Group Type EXPERIMENTAL

Lipitor 20Mg Tablet

Intervention Type DRUG

One tablet by mouth every day for 12 weeks.

Exercise Program

Intervention Type BEHAVIORAL

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.

High Statin & Exercise Group

Participants randomized to this group will undergo high statin treatment (Lipitor 80Mg Tablet) and an aerobic exercise program.

Group Type EXPERIMENTAL

Lipitor 80Mg Tablet

Intervention Type DRUG

One tablet by mouth every day for 12 weeks.

Exercise Program

Intervention Type BEHAVIORAL

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.

Interventions

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Lipitor 20Mg Tablet

One tablet by mouth every day for 12 weeks.

Intervention Type DRUG

Lipitor 80Mg Tablet

One tablet by mouth every day for 12 weeks.

Intervention Type DRUG

Placebo

One matching placebo tablet by mouth every day for 12 weeks.

Intervention Type DRUG

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Atorvastatin Atorvastatin

Eligibility Criteria

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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

Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes