Status:
COMPLETED
Impact of Statin Therapy on Muscle Mitochondrial Function and Aerobic Capacity
Lead Sponsor:
University of Kansas Medical Center
Collaborating Sponsors:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions:
Mitochondrial Diseases
Eligibility:
All Genders
35-65 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to test how different doses of a statin, Lipitor, affect muscle health and function, and cardiovascular fitness.
Eligibility Criteria
Inclusion
- Body mass index (BMI) between 25-43
- 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
- Smoking
- 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
Key Trial Info
Start Date :
February 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 7 2023
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT03351998
Start Date
February 22 2018
End Date
July 7 2023
Last Update
December 18 2024
Active Locations (2)
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1
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
2
East Carolina University
Greenville, North Carolina, United States, 27858