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Impact of Statin Therapy on Muscle Mitochondrial Function and Aerobic Capacity

Sponsor
University of Kansas Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT03351998
Collaborator
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (NIH)
66
Enrollment
2
Locations
3
Arms
64.2
Anticipated Duration (Months)
33
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to test how different doses of a statin, Lipitor, affect muscle health and function, and cardiovascular fitness.

Condition or Disease Intervention/Treatment Phase
  • Drug: Lipitor 20Mg Tablet
  • Drug: Lipitor 80Mg Tablet
  • Drug: Placebo Oral Tablet
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
66 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
Impact of Statin Therapy on Muscle Mitochondrial Function and Aerobic Capacity
Actual Study Start Date :
Feb 22, 2018
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

Participants receiving matching placebo oral tablet.

Drug: Placebo Oral Tablet
Matching placebo pill.
Other Names:
  • Placebo

    		•
    Active Comparator: Low dose statin

    Participants will receive Lipitor 20Mg Tablet to take daily.

    Drug: Lipitor 20Mg Tablet
    20 mg/day pills.
    Other Names:
  • atorvastatin

    		•
    Active Comparator: High dose statin

    Participants will receive Lipitor 80Mg Tablet to take daily.

    Drug: Lipitor 80Mg Tablet
    80 mg/day pills.
    Other Names:
  • atorvastatin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Difference in mitochondrial respiratory function [12 Months]

    Secondary Outcome Measures

    1. VO2 max [12 Months]

    2. Insulin sensitivity [12 Months]

    3. Citrate synthase activity [12 Months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    35 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Body mass index (BMI) between 25-43

    • 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) and/or LDL-Cholesterol >120 mg/dl.

    • 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

    • Previous use of statins

    • 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, other metabolic diseases (e.g., thyroid), current diagnosis and active treatment of cancer, HIV, or acquired immunodeficiency syndrome.

    • Diagnosis of type 1 or type 2 diabetes at the time of screening (fasting blood glucose

    126mg/dL). If evidence of type 2 diabetes outcome measures is detected during the course of the study (fasting glucose > 126 mg/dl or HbA1c > 6.5%) we will notify the participant to contact their physician.

    • 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 (SLCO1B1 and GATM) known to be associated with susceptibility for statin induced myopathies (tested at screening)

    • Currently enrolled in another research study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Kansas Medical Center Kansas City Kansas United States 66160
    2 East Carolina University Greenville North Carolina United States 27858

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: John Thyfault, PhD, University of Kansas Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Kansas Medical Center
    ClinicalTrials.gov Identifier:
    NCT03351998
    Other Study ID Numbers:
    • STUDY00140789
    • R01AR071263
    First Posted:
    Nov 24, 2017
    Last Update Posted:
    May 3, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by University of Kansas Medical Center
    insulin sensitivity
    cardiorespiratory fitness
    skeletal muscle mitochondrial function
    Additional relevant MeSH terms:
    Mitochondrial Diseases
    Atorvastatin

    Study Results

    No Results Posted as of May 3, 2022