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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 : November 6, 2019
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
University of Kansas Medical Center

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.

Condition or disease Intervention/treatment Phase
Mitochondrial Diseases Drug: Lipitor 20Mg Tablet Drug: Lipitor 80Mg Tablet Drug: Placebo Oral Tablet Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 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, 2022
Estimated Study Completion Date : July 1, 2022


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




Primary Outcome Measures :
  1. Difference in mitochondrial respiratory function [ Time Frame: 12 Months ]

Secondary Outcome Measures :
  1. VO2 max [ Time Frame: 12 Months ]
  2. Insulin sensitivity [ Time Frame: 12 Months ]
  3. Citrate synthase activity [ Time Frame: 12 Months ]


Information from the National Library of Medicine

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.


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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Contacts
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Contact: Clara Amat, MS 913-945-8834 camatfernandez@kumc.edu

Locations
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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         
Sponsors and Collaborators
University of Kansas Medical Center
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
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Principal Investigator: John Thyfault, PhD University of Kansas Medical Center
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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: November 6, 2019
Last Verified: November 2019

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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
Keywords provided by University of Kansas Medical Center:
insulin sensitivity
cardiorespiratory fitness
skeletal muscle mitochondrial function
Additional relevant MeSH terms:
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Mitochondrial Diseases
Metabolic Diseases
Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors