Sarcopenia in Chronic Kidney Disease (CKD) Patients
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age45-75
SponsorThe University of Texas Health Science Center at San Antonio
About this trial
Sarcopenia, or loss of muscle and strength is common in patients with poor kidney function. Although a high protein diet is generally recommended for sarcopenia, patients with poor kidney function are advised to follow a low-protein diet. In this study, we will evaluate the practicality and potential benefits of two different amino acids (molecules that form proteins) in improving sarcopenia in patients with advanced kidney disease.
The study aims to improve muscle mass and strength. All study procedures are free of cost and do not require significant time commitment. You will have time to ask questions and discuss the study with your family, primary care physician, and your kidney doctor to make the decision if this is right study for you to participate in.
Eligibility criteria
Qualifiers
Ability of participant to understand and the willingness to sign a written informed consent document.
Males and females of age 45-75 yrs
Hand grip strength of <26 kg for male and <16 kg for female
Documented diagnosis of estimated glomerular filtration rate (eGFR) of ≤15 mL/min/1.73 m2, based on CKD-EPI serum-creatinine based formula in the past ≥3 months in absence of acute kidney injury.
Disqualifiers
Any known history of hypersensitivity/intolerance to valine or specific amino acids
Any condition that may indicate the individual is not "metabolically stable" which may include active infection, currently on systemic antibiotic, hospitalization within 2 weeks on consenting, active malignancy, on immunosuppressive agents, and unexplained significant weight loss during the past 3 months
With a cardiac pacemaker and/or an implantable cardioverter-defibrillator
Significant arthritis prohibiting strength test and walk gait speed test
Trial design
Treatments tested in this trial
- Valine
- EEA
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
The University of Texas Health Science Center at San Antonio
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov