RECRUITING

CoQ10 and Exercise for Mitochondrial Dysfunction in Advance Kidney Disease

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-06-01
Study Completion:2027-10-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05422534

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subjects age 18 to 75 years
  2. * On thrice-weekly chronic hemodialysis for at least 6 months (only applicable for patients with ESRD on maintenance hemodialysis).
  3. * Clinically stable, adequately dialyzed (single-pool Kt/V \>1.2) thrice weekly, for at least 3 consecutive months prior to the study (only applicable for patients with ESRD on maintenance hemodialysis)
  1. * Body mass index \> 35 mg/kg2
  2. * History of functional transplant less than 6 months prior to study
  3. * Use of immunosuppressive drugs within 1 month prior to study
  4. * Active connective tissue disease
  5. * Acute infectious disease within 1 month prior to study
  6. * AIDS (HIV seropositivity is not an exclusion criterion)
  7. * Acute myocardial infarction or cerebrovascular event within 3 months
  8. * Uncontrolled blood pressure
  9. * New or worsening mitral regurgitation murmur
  10. * Hypotension, bradycardia, or tachycardia
  11. * Prolonged ongoing (greater than 20 minutes) angina at rest
  12. * Angina at rest with transient ST changes greater than 0.05 mV on ECG
  13. * Sustained ventricular tachycardia on ECG
  14. * Elevated cardiac enzymes (e.g., troponin Tor I greater than 0.1mg/ml)
  15. * Advanced liver disease, with a modified Child-Turcotte-Pugh score equal or greater than 10.
  16. * Gastrointestinal dysfunction requiring parental nutrition
  17. * Active malignancy excluding basal cell carcinoma of the skin
  18. * Ejection fraction less than 30%
  19. * Pre-dialysis potassium repeatedly higher than 5.5 mmol/L (confirmed on a repeated blood draw)
  20. * Anticipated live donor kidney transplant
  21. * History of poor adherence to hemodialysis or medical regimen
  22. * Inability to provide consent
  23. * Subjects with cardiac pacemaker, artificial heart valve, any metallic implant, permanent tattoo, or any retained foreign metallic bodies.
  24. * Inability to perform exercise
  25. * Contraindication for exercise such as electrolyte abnormalities, uncontrolled arrhythmias, or pulmonary congestion.

Contacts and Locations

Study Contact

Delia M Woods, BSN/MSL
CONTACT
615-322-1749
delia.woods@vumc.org
Patricia Wright, BSN
CONTACT
615-322-8837
patricia.wright@vumc.org

Principal Investigator

Jorge Gamboa, MD/PhD
PRINCIPAL_INVESTIGATOR
VUMC
Talat Ikizler, MD
PRINCIPAL_INVESTIGATOR
VUMC
Baback Roshanravan, MD/MPH
PRINCIPAL_INVESTIGATOR
University of California, Davis

Study Locations (Sites)

University of California Davis Health
Sacramento, California, 95817
United States
Vanderbilt University Medical Center-GCRC
Nashville, Tennessee, 37232
United States

Collaborators and Investigators

Sponsor: Vanderbilt University Medical Center

  • Jorge Gamboa, MD/PhD, PRINCIPAL_INVESTIGATOR, VUMC
  • Talat Ikizler, MD, PRINCIPAL_INVESTIGATOR, VUMC
  • Baback Roshanravan, MD/MPH, PRINCIPAL_INVESTIGATOR, University of California, Davis

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-01
Study Completion Date2027-10-01

Study Record Updates

Study Start Date2023-06-01
Study Completion Date2027-10-01

Terms related to this study

Keywords Provided by Researchers

  • mitochondrial dysfunction
  • CoQ10
  • sarcopenia
  • frailty
  • High-intensity interval training (HIIT)
  • exercise
  • magnetic resonance spectroscopy (P-MRS)
  • physical performance tests

Additional Relevant MeSH Terms

  • End Stage Renal Disease