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Impact of Statin Therapy on Muscle Mitochondrial Function and Aerobic Capacity

Primary Purpose

Mitochondrial Diseases

Status

Active

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Lipitor 20Mg Tablet

Lipitor 80Mg Tablet

Placebo Oral Tablet

About this trial

This is an interventional prevention trial for Mitochondrial Diseases focused on measuring insulin sensitivity, cardiorespiratory fitness, skeletal muscle mitochondrial function

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

University of Kansas Medical Center
East Carolina University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Low dose statin

High dose statin

Arm Description

Participants receiving matching placebo oral tablet.

Participants will receive Lipitor 20Mg Tablet to take daily.

Participants will receive Lipitor 80Mg Tablet to take daily.

Outcomes

Primary Outcome Measures

Difference in mitochondrial respiratory function

Secondary Outcome Measures

VO2 max

Insulin sensitivity

Citrate synthase activity

Full Information

NCT ID

NCT03351998

First Posted

November 20, 2017

Last Updated

March 30, 2023

Sponsor

University of Kansas Medical Center

Collaborators

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

1. Study Identification

Unique Protocol Identification Number

NCT03351998

Brief Title

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

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

February 22, 2018 (Actual)

Primary Completion Date

July 1, 2023 (Anticipated)

Study Completion Date

July 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Kansas Medical Center

Collaborators

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mitochondrial Diseases

Keywords

insulin sensitivity, cardiorespiratory fitness, skeletal muscle mitochondrial function

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

68 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Participants receiving matching placebo oral tablet.

Arm Title

Low dose statin

Arm Type

Active Comparator

Arm Description

Participants will receive Lipitor 20Mg Tablet to take daily.

Arm Title

High dose statin

Arm Type

Active Comparator

Arm Description

Participants will receive Lipitor 80Mg Tablet to take daily.

Intervention Type

Drug

Intervention Name(s)

Lipitor 20Mg Tablet

Other Intervention Name(s)

atorvastatin

Intervention Description

20 mg/day pills.

Intervention Type

Drug

Intervention Name(s)

Lipitor 80Mg Tablet

Other Intervention Name(s)

atorvastatin

Intervention Description

80 mg/day pills.

Intervention Type

Drug

Intervention Name(s)

Placebo Oral Tablet

Other Intervention Name(s)

Placebo

Intervention Description

Matching placebo pill.

Primary Outcome Measure Information:

Title

Difference in mitochondrial respiratory function

Time Frame

12 Months

Secondary Outcome Measure Information:

Title

VO2 max

Time Frame

12 Months

Title

Insulin sensitivity

Time Frame

12 Months

Title

Citrate synthase activity

Time Frame

12 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John Thyfault, PhD

Organizational Affiliation

University of Kansas Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Kansas Medical Center

City

Kansas City

State/Province

Kansas

ZIP/Postal Code

66160

Country

United States

Facility Name

East Carolina University

City

Greenville

State/Province

North Carolina

ZIP/Postal Code

27858

Country

United States

12. IPD Sharing Statement

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Impact of Statin Therapy on Muscle Mitochondrial Function and Aerobic Capacity

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