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Pharmacogenomic Modulators of Impaired Exercise Adaptation in Statin Users

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04636138
Recruitment Status : Recruiting
First Posted : November 19, 2020
Last Update Posted : November 24, 2021
Sponsor:
Information provided by (Responsible Party):
University of Kansas Medical Center

Study Description
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Brief 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. 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 or disease Intervention/treatment Phase
HMG-CoA Reductase Inhibitor Toxicity Other: Exercise Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Pharmacogenomic Modulators of Impaired Exercise Adaptation in Statin Users
Actual Study Start Date : June 3, 2021
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Peak oxygen consumption (VO2max) [ Time Frame: 6 weeks ]
    Change pre/post intervention; compared with genomic variants


Secondary Outcome Measures :
  1. Resting heart rate [ Time Frame: 6 weeks ]
  2. Resting systolic blood pressure [ Time Frame: 6 weeks ]
  3. Weight [ Time Frame: 6 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04636138


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

Locations
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United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Daniel J Parente, MD PhD         
Principal Investigator: Daniel J Parente, MD PhD         
Sub-Investigator: Sandra Billinger, PhD PT         
Sponsors and Collaborators
University of Kansas Medical Center
Investigators
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Principal Investigator: Daniel J Parente, MD PhD University of Kansas Medical Center
More Information
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Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT04636138    
Other Study ID Numbers: STUDY00145686
First Posted: November 19, 2020    Key Record Dates
Last Update Posted: November 24, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No