Impact of Statin Therapy on Muscle Mitochondrial Function and Aerobic Capacity

Mitochondrial Diseases Clinical Trial

Official title:

Impact of Statin Therapy on Muscle Mitochondrial Function and Aerobic Capacity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03351998
• Other study ID #: STUDY00140789
• Secondary ID: R01AR071263
• Status: Completed
• Phase: Phase 4
• Start date: February 22, 2018
• Est. completion date: July 7, 2023

Study information

• Verified date: December 2023
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test how different doses of a statin, Lipitor, affect muscle health and function, and cardiovascular fitness.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: July 7, 2023
• Est. primary completion date: July 7, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Mitochondrial Diseases

Intervention

Drug:
• Lipitor 20Mg Tablet
20 mg/day pills.
• Lipitor 80Mg Tablet
80 mg/day pills.
• Placebo Oral Tablet
Matching placebo pill.

Locations

Country	Name	City	State
United States	East Carolina University	Greenville	North Carolina
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in mitochondrial respiratory function		12 Months
Secondary	VO2 max		12 Months
Secondary	Insulin sensitivity		12 Months
Secondary	Citrate synthase activity		12 Months