Pharmacogenomic Modulators of Impaired Exercise Adaptation in Statin Users

NCT04636138 | Active Not Recruiting

• 1 other identifier: STUDY00145686
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

HMG-CoA Reductase Inhibitor Toxicity

Outcome Measures

Primary Outcomes (1)

• Peak oxygen consumption (VO2max)

  Change pre/post intervention; compared with genomic variants

  6 weeks

Secondary Outcomes (3)

• Resting heart rate

  6 weeks

• Resting systolic blood pressure

  6 weeks

• Weight

  6 weeks

Study Arms (1)

Single arm

EXPERIMENTAL

Other: Exercise

Interventions

Exercise OTHER

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.

Single arm

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Daniel J Parente, MD PhD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2020
• First Posted: November 19, 2020
• Study Start: June 3, 2021
• Primary Completion: July 30, 2023
• Study Completion (Estimated): July 30, 2026
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)