Pharmacogenomic Modulators of Impaired Exercise Adaptation in Statin Users
Purpose
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.
Condition
- HMG-CoA Reductase Inhibitor Toxicity
Eligibility
- Eligible Ages
- Between 35 Years and 65 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Basic Science
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Single arm |
|
Recruiting Locations
University of Kansas Medical Center
Kansas City, Kansas 66160
Kansas City, Kansas 66160
Contact:
Daniel J Parente, MD PhD
Daniel J Parente, MD PhD
More Details
- Status
- Unknown status
- Sponsor
- University of Kansas Medical Center