Clinical trial NCT03351998: Impact of Statin Therapy on Muscle Mitochondrial Function and Aerobic Capacity
Official title: Impact of Statin Therapy on Muscle Mitochondrial Function and Aerobic Capacity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Mitochondrial Diseases
Keywords: insulin sensitivity
cardiorespiratory fitness
skeletal muscle mitochondrial function
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2017-11-24
Enrollment: 68
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Difference in Mitochondrial Respiratory Function
timeFrame: value at 12 months minus value at baseline
Secondary outcomes:
measure: Change in VO2 Max
timeFrame: value at 12 months minus value at baseline
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
Study officials:
affiliation: University of Kansas Medical Center
name: John Thyfault, PhD
role: PRINCIPAL_INVESTIGATOR
References: