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

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

ArmDescriptionAssigned Intervention
Experimental
Single arm
  • Other: Exercise
    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.

Recruiting Locations

University of Kansas Medical Center
Kansas City, Kansas 66160
Contact:
Daniel J Parente, MD PhD

More Details

Status
Unknown status
Sponsor
University of Kansas Medical Center

Study Contact

Daniel J Parente, MD PhD
9139458054
dparente@kumc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.