Impact of Statin Therapy on Adaptations to Aerobic Exercise

NCT03360916 | Completed Phase 4 Results DMC FDA Drug

• 2 other identifiers: STUDY00140791R01AR071263
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cardiovascular Diseases

Keywords

high cholesterol; exercise; statins

Outcome Measures

Primary Outcomes (1)

• Difference in Mitochondrial Respiratory Function

  Value at 3 months minus value at baseline

Secondary Outcomes (1)

• Change in VO2 Max

  Value at 12 months minus value at baseline

Study Arms (3)

Placebo & Exercise Group

PLACEBO COMPARATOR

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

Drug: Placebo; Behavioral: Exercise Program

Low Statin & Exercise Group

EXPERIMENTAL

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

Drug: Lipitor 20Mg Tablet; Behavioral: Exercise Program

High Statin & Exercise Group

EXPERIMENTAL

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

Drug: Lipitor 80Mg Tablet; Behavioral: Exercise Program

Interventions

Lipitor 20Mg Tablet DRUG

One tablet by mouth every day for 12 weeks.

Also known as: Atorvastatin

Low Statin & Exercise Group

Lipitor 80Mg Tablet DRUG

One tablet by mouth every day for 12 weeks.

Also known as: Atorvastatin

High Statin & Exercise Group

Placebo DRUG

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

Placebo & Exercise Group

Exercise Program 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; Low Statin & Exercise Group; Placebo & Exercise Group

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Hypercholesterolemia; Motor Activity

Interventions

Atorvastatin; Tablets; Resistance Training

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Dosage Forms; Pharmaceutical Preparations; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Limitations and Caveats

The COVID-19 epidemic started in the middle of the trial forcing us to stop recruitment for four months. Furthermore, the continuation of the pandemic slowed recruitment for the rest of the trial and significantly impacted n size. There was also a national dextrose shortage following a hurricane in Puerto Rico. As a result many of the IVGTT were not conducted.

Results Point of Contact

• Title: John P. Thyfault
• Organization: University of Kansas Medical Center

jthyfault@kumc.edu

913-588-1790

Study Officials

• John Thyfault, PhD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2017
• First Posted: December 4, 2017
• Study Start: February 1, 2018
• Primary Completion: June 5, 2024
• Study Completion: June 5, 2024
• Last Updated: April 15, 2025
• Results First Posted: April 15, 2025

Record last verified: 2025-04

Locations

US (1)