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OpenTrials
Completed

NCT Number: NCT03351998

Impact of Statin Therapy on Muscle Mitochondrial Function and Aerobic Capacity

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

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Key information

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Kansas Medical Center, Kansas City, Kansas, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lipitor 20Mg Tablet

Drug

20 mg/day pills.

Other names: atorvastatin

Lipitor 80Mg Tablet

Drug

80 mg/day pills.

Other names: atorvastatin

Placebo oral tablet

Drug

Matching placebo pill.

Other names: Placebo

Primary outcomes

  1. Difference in Mitochondrial Respiratory Function

    Time frame: value at 12 months minus value at baseline

Secondary outcomes

  1. Change in VO2 Max

    Time frame: value at 12 months minus value at baseline

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Registry information

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Nov 24, 2017
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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