Pharmacogenomic Modulators of Impaired Exercise Adaptation in Statin Users

  • STATUS
    Recruiting
  • End date
    Jul 1, 2021
  • participants needed
    21
  • sponsor
    University of Kansas Medical Center
Updated on 26 January 2021

Summary

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. We hypothesize that these variations modulate the relationship between statin use and lack of benefit from exercise. We 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 patient.

Details
Condition HMG-CoA Reductase Inhibitor Toxicity, HMG-CoA Reductase Inhibitor Toxicity, HMG-CoA Reductase Inhibitor Toxicity
Treatment Exercise
Clinical Study IdentifierNCT04636138
SponsorUniversity of Kansas Medical Center
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 35 yrs and 65 yrs?
Gender: Male or Female
Do you have any of these conditions: Do you have HMG-CoA Reductase Inhibitor Toxicity??
We will study English-speaking adults (aged 35-65 years)
who are overweight or obese (body-mass index [BMI] 25-43), currently taking
high-dose atorvastatin (80mg once daily) for primary prevention of
cardiovascular disease and/or stroke, are sedentary (<30 minutes of structured
exercise weekly), willing to participate in supervised exercise three times
weekly and to not make intentional changes to their diet during the study
period

Exclusion Criteria

We will exclude patients who (a) smoke, (b) are pregnant or breastfeeding, (c)
use other medications that affect lipid metabolism (e.g. fibric acid, fish
oil), (d) who are 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 (e) who have been advised by a physician to avoid
exercise due to comorbid serious cardiovascular disease, (f) uncontrolled
diabetes (A1c > 8), uncontrolled thyroid disease, HIV/AIDS, cancer, (g)
history of myocardial infarction or stroke, or (h) history of statin-induced
myopathy
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