Impact of Statin Therapy on Muscle Mitochondrial Function and Aerobic Capacity
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03351998 |
Recruitment Status :
Recruiting
First Posted : November 24, 2017
Last Update Posted : December 19, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Mitochondrial Diseases | Drug: Lipitor 20Mg Tablet Drug: Lipitor 80Mg Tablet Drug: Placebo Oral Tablet | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 66 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Prevention |
Official Title: | Impact of Statin Therapy on Muscle Mitochondrial Function and Aerobic Capacity |
Actual Study Start Date : | February 22, 2018 |
Estimated Primary Completion Date : | July 1, 2023 |
Estimated Study Completion Date : | July 1, 2023 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo
Participants receiving matching placebo oral tablet.
|
Drug: Placebo Oral Tablet
Matching placebo pill.
Other Name: Placebo |
Active Comparator: Low dose statin
Participants will receive Lipitor 20Mg Tablet to take daily.
|
Drug: Lipitor 20Mg Tablet
20 mg/day pills.
Other Name: atorvastatin |
Active Comparator: High dose statin
Participants will receive Lipitor 80Mg Tablet to take daily.
|
Drug: Lipitor 80Mg Tablet
80 mg/day pills.
Other Name: atorvastatin |
- Difference in mitochondrial respiratory function [ Time Frame: 12 Months ]
- VO2 max [ Time Frame: 12 Months ]
- Insulin sensitivity [ Time Frame: 12 Months ]
- Citrate synthase activity [ Time Frame: 12 Months ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 35 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03351998
Contact: Annie Eller, RD | 913-735-5411 | aeller2@kumc.edu |
United States, Kansas | |
University of Kansas Medical Center | Recruiting |
Kansas City, Kansas, United States, 66160 | |
United States, North Carolina | |
East Carolina University | Recruiting |
Greenville, North Carolina, United States, 27858 | |
Contact: Patty Brophy | |
Principal Investigator: Darrell Neufer, PhD |
Principal Investigator: | John Thyfault, PhD | University of Kansas Medical Center |
Responsible Party: | University of Kansas Medical Center |
ClinicalTrials.gov Identifier: | NCT03351998 |
Other Study ID Numbers: |
STUDY00140789 R01AR071263 ( U.S. NIH Grant/Contract ) |
First Posted: | November 24, 2017 Key Record Dates |
Last Update Posted: | December 19, 2022 |
Last Verified: | December 2022 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
insulin sensitivity cardiorespiratory fitness skeletal muscle mitochondrial function |
Mitochondrial Diseases Metabolic Diseases Atorvastatin Anticholesteremic Agents Hypolipidemic Agents |
Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |