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OpenTrials
Active, Not Recruiting

NCT Number: NCT04636138

Pharmacogenomic Modulators of Impaired Exercise Adaptation in Statin Users

3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statins) have beneficial effects (prevent stroke, heart attack) but also some bad ones (block some good effects of exercise). Individuals have genetic variations in proteins that metabolize/transport statins. The investigators hypothesize that these variations modulate the relationship between statin use and lack of benefit from exercise. The investigators will test this by having statin-users do supervised exercise for 6 weeks, measuring the cardiorespiratory fitness before/after and correlating this to genetic variations present in the participant.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

HMG-CoA Reductase Inhibitor Toxicity

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • English-speaking
  • Adults (aged 35-65 years)
  • Overweight or obese (body-mass index [BMI] 25-43)
  • Currently taking high-dose atorvastatin (40-80mg once daily) for primary prevention of cardiovascular disease and/or stroke
  • Sedentary (<30 minutes of structured exercise weekly)
  • Willing to participate in supervised exercise three times weekly
  • Willing to not make intentional changes to their diet during the study period.

Exclusion criteria

  • Tobacco smokers
  • Pregnant or breastfeeding
  • Use other medications that affect lipid metabolism (e.g. fibric acid, fish oil)
  • Markedly functional debilitated and unable to exert 4 metabolic equivalents (METs) of energy (e.g. unable to climb a flight of stairs without stopping), or who have
  • Been advised by a physician to avoid exercise due to comorbid serious cardiovascular disease
  • Uncontrolled diabetes (A1c > 8)
  • Uncontrolled thyroid disease
  • HIV/AIDS
  • Cancer
  • History of myocardial infarction or stroke
  • History of statin-induced myopathy.

Treatment and study plan

Exercise

Other

Patients will exercise on a treadmill three times weekly at approximately 60% VO2max for 30 minutes (week one) followed by 45 minutes (week two and thereafter) for a total of 6 seeks.

Primary outcomes

  1. Peak oxygen consumption (VO2max)

    Time frame: 6 weeks

    Change pre/post intervention; compared with genomic variants

Secondary outcomes

  1. Resting heart rate

    Time frame: 6 weeks

  2. Resting systolic blood pressure

    Time frame: 6 weeks

  3. Weight

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2026
First posted
Nov 19, 2020
Registry last updated
Dec 26, 2025

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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