Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Chronic Kidney Disease
  • Frailty
  • Sarcopenia
Type
Interventional
Phase
Phase 2
Design
Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: Randomized, placebo-controlled, cross-over trialMasking: Triple (Participant, Care Provider, Investigator)Primary Purpose: Treatment

Participation Requirements

Age
Between 30 years and 79 years
Gender
Both males and females

Description

Sarcopenia (decreased muscle mass or function) is common in patients with chronic kidney disease (CKD) patients with direct impacts on their metabolic and clinical outcomes. Existing evidence and the investigator's preliminary data suggest that mitochondrial dysfunction is a key underlying mechanism...

Sarcopenia (decreased muscle mass or function) is common in patients with chronic kidney disease (CKD) patients with direct impacts on their metabolic and clinical outcomes. Existing evidence and the investigator's preliminary data suggest that mitochondrial dysfunction is a key underlying mechanism of sarcopenia in CKD. However, the ability of treatments to modify mitochondrial functioning in CKD patients is unknown. Coenzyme Q10 (coQ10) and nicotinamide riboside (NR) are naturally occurring supplements that reduce oxidative stress and restore substrate delivery to mitochondria, respectively. Both processes have the potential to increase mitochondrial energy production with direct consequences for many metabolic and physical processes, including: aerobic capacity work efficiency mitochondrial energetics fatigue physical function inflammation oxidative stress heart failure symptoms metabolomics These outcomes will assessed in all study participants who enroll in the trial. Addressing these knowledge gaps is necessary to shed new light on the pathophysiology of sarcopenia in CKD and suggest future interventions that reduce morbidity and mortality. This is a randomized, placebo-controlled, double-blind crossover trial of coQ10 and NR treatments. Participants will receive coQ10 (1000 mg daily), NR (1200 mg daily), or placebo each for six-weeks in random order with a 7-day washout between treatment periods. The primary outcomes are aerobic capacity and muscle work efficiency, measured during cycle ergometry.

Tracking Information

NCT #
NCT03579693
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Bryan Kestenbaum, MD University of Washington Principal Investigator: Baback Roshanravan, MD University of Washington