RecruitingPhase 3NCT05422534

CoQ10 and Exercise for Mitochondrial Dysfunction in Advance Kidney Disease

Role of Mitochondrial Dysfunction in the Response to Exercise in Patients With Advance Kidney Disease


Sponsor

Vanderbilt University Medical Center

Enrollment

156 participants

Start Date

Jun 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Frailty and sarcopenia are modifiable risk factors for morbidity and mortality in patients with ESRD. Exercise is the recommended intervention to prevent frailty and sarcopenia, however, many clinical trials have shown limited clinical improvement in muscle mass and physical function. We propose that mitochondrial dysfunction is one of the deterrents to the effectiveness of the exercise. We plan to evaluate the additive effect of HIIT and CoQ10, a mitochondrial-targeted therapy, on mitochondrial function and physical performance. Understanding the interplay among CoQ10, exercise, and mitochondrial function will identify novel mechanisms to improve the efficiency of exercise. This will also serve to prevent frailty, sarcopenia, and muscle dysfunction in patients with ESRD.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether a combination of coenzyme Q10 (CoQ10) supplements and exercise can help treat mitochondrial dysfunction — essentially, poor energy production in cells — in people with advanced kidney disease on dialysis. **You may be eligible if:** - You are between 18 and 75 years old - You have end-stage kidney disease and have been on hemodialysis three times a week for at least 6 months - Your dialysis is working well (adequate clearance levels) - You are otherwise clinically stable **You may NOT be eligible if:** - Your BMI is over 35 - You had a kidney transplant in the past 6 months - You are taking immunosuppressant medications - You have an active infection or connective tissue disease - You recently had a heart attack or stroke (within 3 months) - You have uncontrolled blood pressure, abnormal heart rhythms, or chest pain at rest - Your heart pumping function is below 30% - You have active cancer (other than minor skin cancer) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTCoQ10

Participants will receive 1800 mg/day for 12 weeks

DRUGPlacebo

Participants will receive placebo or CoQ10/day for 12 weeks

BEHAVIORALHB-HIIT

Participants will be performed on non dialysis days. It will be video supervised exercise sessions with self directed exercises using pre-recorded bodyweight and strength exercise videos.

BEHAVIORALObservational

Participant regular activities


Locations(2)

University of California Davis Health

Sacramento, California, United States

Vanderbilt University Medical Center-GCRC

Nashville, Tennessee, United States

View Full Details on ClinicalTrials.gov

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NCT05422534


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