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NCT03360916CompletedPhase 4

Impact of Statin Therapy on Adaptations to Aerobic Exercise

Source: ClinicalTrials.gov · Last updated 15 Apr 2025

Brief summary (registry, in English)

The purpose of this study is to determine how different doses of a statin affect muscle health and exercise.

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
52 (actual)
First submitted
20 Nov 2017
Start date
1 Feb 2018
Primary completion date
5 Jun 2024
Lead sponsor
University of Kansas Medical Center
NCT number
NCT03360916

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 52
  • From 1 Feb 2018 to the primary completion date, 5 Jun 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Use of other medications or supplements that affect lipid profiles or body weight in the last 6 months (e.g., fibric acids, bile acid sequestrants, nicotinic acids, fish oil)

Other illness

  • Diagnosis of chronic diseases including CVD, diabetes, other metabolic diseases (e.g., thyroid), cancer, HIV, or acquired immunodeficiency syndrome
  • History of abnormal bleeding problems

Lab values

  • Currently taking (within the last 10 days) anti-platelet medication (Plavix), Warfarin, and other anti-coagulants (eliquis, pradaxa, and xarelto) medications
  • \>2 fold upper normal limit (UNL) for alanine aminotransferase (ALT) or creatinine

Other

  • Smoking
  • Use of statins in the last 6 months
  • Women who are pregnant or breastfeeding
  • Individuals with polymorphisms known to be associated with susceptibility for statin induced myopathies (tested at screening)
  • Currently enrolled in another research study

Who the study is looking for

  • Body Mass Index (BMI) between 25-43 kg\^m2
  • Sedentary (less than 150 min of physical activity/week during last 6 months)
  • Weight stable (no more than 5% change in body weight the previous 3 months)
    • \>5% risk for a cardiovascular event in the next 10 years according to the 2013 American College of Cardiology/American Heart Association risk calculator and/or 2 out of 5 metabolic syndrome risk factors(Triglycerides ≥ 150 mg/dL; HDL ≤ 40 mg/dL; Glucose ≥ 100mg/dL; Waist Circumference ≥ 102cm for males, 88cm for females; Blood pressure: ≥ 130mmHg systolic and/or 85mmHg diastolic or being treated for hypertension).
  • Stable doses of medications for 90 days
  • Willing to stop all Nonsteroidal Antiinflammatory Drugs (NSAIDs) and aspirin for 7 days prior to muscle biopsy

Age in the registry: 35 years to 65 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Kansas Medical Center
Coordinator of this site? Confirm its status
Kansas CityUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.