Impact of Statin Therapy on Adaptations to Aerobic Exercise

Cardiovascular Diseases Clinical Trial

Official title:

Impact of Statin Therapy on Adaptations to Aerobic Exercise

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03360916
• Other study ID #: STUDY00140791
• Secondary ID: R01AR071263
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: February 1, 2018
• Est. completion date: May 30, 2024

Study information

• Verified date: December 2023
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 119
• Est. completion date: May 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Drug:
• Lipitor 20Mg Tablet
One tablet by mouth every day for 12 weeks.
• Lipitor 80Mg Tablet
One tablet by mouth every day for 12 weeks.
• 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.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxygen Consumption	Changes in cardiorespiratory fitness measured by oxygen consumption during increased exercise on a motorized treadmill and during lower intensity exercise sessions. Oxygen consumption will be measured at peak and at various time points to determine fitness.	Change from Baseline to Week 12
Secondary	Mitochondrial respiratory function	Mitochondrial respiration will be measured by commercially available O2k Oroboros device.	Change from Baseline to Week 12
Secondary	Insulin sensitivity	Insulin sensitivity will be measured by a standardized intravenous glucose tolerance test (IVGTT) in which glucose and insulin responses are monitored following glucose infusion.	Change from Baseline to Week 12
Secondary	Citrate synthase activity	This will be measured by an enzyme activity assay.	Change from Baseline to Week 12