Pharmacogenomic Modulators of Impaired Exercise Adaptation in Statin Users
- Conditions
- HMG-CoA Reductase Inhibitor Toxicity
- Interventions
- Other: Exercise
- Registration Number
- NCT04636138
- Lead Sponsor
- University of Kansas Medical Center
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 5
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single arm Exercise -
- Primary Outcome Measures
Name Time Method Peak oxygen consumption (VO2max) 6 weeks Change pre/post intervention; compared with genomic variants
- Secondary Outcome Measures
Name Time Method Resting systolic blood pressure 6 weeks Resting heart rate 6 weeks Weight 6 weeks
Trial Locations
- Locations (1)
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States