Impact of Statin Therapy on Muscle Mitochondrial Function and Aerobic Capacity
NCT ID: NCT03351998
Last Updated: 2024-12-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
68 participants
INTERVENTIONAL
2018-02-22
2023-07-07
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Placebo
Participants receiving matching placebo oral tablet.
Placebo Oral Tablet
Matching placebo pill.
Low dose statin
Participants will receive Lipitor 20Mg Tablet to take daily.
Lipitor 20Mg Tablet
20 mg/day pills.
High dose statin
Participants will receive Lipitor 80Mg Tablet to take daily.
Lipitor 80Mg Tablet
80 mg/day pills.
Interventions
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Lipitor 20Mg Tablet
20 mg/day pills.
Lipitor 80Mg Tablet
80 mg/day pills.
Placebo Oral Tablet
Matching placebo pill.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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) and/or LDL-Cholesterol \>120 mg/dl.
* Stable doses of medications for 90 days
* Willing to stop all Nonsteroidal Antiinflammatory Drugs (NSAIDs) and aspirin for 7 days prior to muscle biopsy
Exclusion Criteria
* Previous use of statins
* 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)
* Diagnosis of chronic diseases including CVD, other metabolic diseases (e.g., thyroid), current diagnosis and active treatment of cancer, HIV, or acquired immunodeficiency syndrome.
* Diagnosis of type 1 or type 2 diabetes at the time of screening (fasting blood glucose \>126mg/dL). If evidence of type 2 diabetes outcome measures is detected during the course of the study (fasting glucose \> 126 mg/dl or HbA1c \> 6.5%) we will notify the participant to contact their physician.
* History of abnormal bleeding problems
* 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
* Women who are pregnant or breastfeeding
* Individuals with polymorphisms (SLCO1B1 and GATM) known to be associated with susceptibility for statin induced myopathies (tested at screening)
* Currently enrolled in another research study
35 Years
65 Years
ALL
Yes
Sponsors
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National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
NIH
University of Kansas Medical Center
OTHER
Responsible Party
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Principal Investigators
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John Thyfault, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Kansas Medical Center
Locations
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University of Kansas Medical Center
Kansas City, Kansas, United States
East Carolina University
Greenville, North Carolina, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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STUDY00140789
Identifier Type: -
Identifier Source: org_study_id