RECRUITING

Sodium Bicarbonate and Mitochondrial Energetics in Persons With CKD

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

Skeletal muscle metabolic health is critical for mobility and an underrecognized target of metabolic acidosis in chronic kidney disease. Impaired muscle mitochondrial metabolism underlies poor physical endurance increasing the risk of mobility disability. The proposed project will use precise in vivo tools to study the pathophysiology of poor physical endurance in a clinical trial treating metabolic acidosis among persons living with chronic kidney disease.

Official Title

Randomized Cross-over Trial of Sodium Bicarbonate on Muscle Mitochondrial Energetics and Physical Endurance in Chronic Kidney Disease and Metabolic Acidosis

Quick Facts

Study Start:2023-09-08
Study Completion:2026-07-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04984226

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:21 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Moderate-severe CKD determined by eGFR \<50ml/min per 1.73m2 by CKD EPI equation on at least 2 consecutive occasions.
  2. * Metabolic acidosis defined as bicarbonate level\<24 on two consecutive occasions. Bicarbonate level of 24 or less allowed if eGFR\<=45ml/min per 1.73m2
  3. * Age 21 to 85 years old
  1. * Type 2 diabetes managed with insulin treatment
  2. * Poorly controlled diabetes (HgbA1c\>10%)
  3. * History of persistent hyperkalemia (K\>5.4)
  4. * Chronic treatment with renal replacement therapy
  5. * History of aortic dissection or severe valvular heart disease
  6. * Exercise induced angina
  7. * Uncontrolled cardiac dysrhythmia
  8. * Oxygen dependent COPD
  9. * Symptomatic claudication
  10. * End stage liver disease
  11. * Mobility disability defined as inability to walk without human assistance
  12. * Dementia or psychosis
  13. * Patients who cannot consent
  14. * Active use of IV drugs
  15. * Non-english speaking
  16. * History of transplant
  17. * Implants that prohibit MRI measurements or trauma involving metal fragments
  18. * Pacemaker
  19. * Expectation to start dialysis during the course of study.
  20. * Any condition which in the judgement of the clinical investigator places the participant at risk from participation in the study.

Contacts and Locations

Study Contact

Baback Roshanravan, MD
CONTACT
530-754-0893
broshanr@ucdavis.edu

Principal Investigator

Baback Roshanravan, MD
PRINCIPAL_INVESTIGATOR
UC Davis
Jorge Gamboa, MD PhD
PRINCIPAL_INVESTIGATOR
Vanderbilt University

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of California, Davis

  • Baback Roshanravan, MD, PRINCIPAL_INVESTIGATOR, UC Davis
  • Jorge Gamboa, MD PhD, PRINCIPAL_INVESTIGATOR, Vanderbilt University

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 Date2023-09-08
Study Completion Date2026-07-30

Study Record Updates

Study Start Date2023-09-08
Study Completion Date2026-07-30

Terms related to this study

Keywords Provided by Researchers

  • Metabolic acidosis
  • Chronic kidney disease
  • Insulin resistance

Additional Relevant MeSH Terms

  • Chronic Kidney Diseases
  • Metabolic Acidosis
  • Fatigue
  • Physical Endurance
  • Insulin Resistance
  • Mitochondrial Energetics
  • Diabetes