Pharmacogenomic Modulators of Impaired Exercise Adaptation in Statin Users
NCT ID: NCT04636138
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
5 participants
INTERVENTIONAL
2021-06-03
2026-07-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Single arm
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
35 Years
65 Years
ALL
Yes
Sponsors
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University of Kansas Medical Center
OTHER
Responsible Party
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Principal Investigators
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Daniel J Parente, MD PhD
Role: PRINCIPAL_INVESTIGATOR
University of Kansas Medical Center
Locations
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University of Kansas Medical Center
Kansas City, Kansas, United States
Countries
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Other Identifiers
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STUDY00145686
Identifier Type: -
Identifier Source: org_study_id