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

What this Trial Is About

Researchers are studying skeletal muscle metabolic health and its role in mobility and endurance among people with chronic kidney disease (CKD) and metabolic acidosis. This condition affects many adults and leads to muscle weakness, insulin resistance, and reduced physical endurance. The study aims to understand how treating metabolic acidosis might improve muscle mitochondrial function, physical endurance, and overall quality of life in people with moderate to severe CKD. The study compares the effects of sodium bicarbonate versus a placebo in a randomized crossover trial involving 80 participants. Sodium bicarbonate is dosed based on ideal body weight, with capsules taken daily for 16 weeks, followed by a switch to the other treatment for another 16 weeks. Researchers will use advanced imaging and metabolic tests to evaluate muscle mitochondrial energy production and insulin sensitivity during each treatment period. Participants will undergo multiple assessments including 31Phosphorus Magnetic Resonance Spectroscopy (31P MRS) to measure muscle mitochondrial capacity, insulin clamps to test insulin sensitivity, exercise tests on a cycle ergometer, and walking endurance tests. They will also complete questionnaires about fatigue. The study monitors physical endurance, muscle work efficiency, muscle fat content, and fatigue over the course of treatment. Total participation lasts around 32 weeks with safety and metabolic health closely observed.

Sodium Bicarbonate and Mitochondrial Energetics in Persons With CKD