Logo 1 Logo 2

Clinical Trial Details

Trial ID: L0137
Source ID: NCT05928936
Associated Drug: Sodium Bicarbonate
Title: Neurovascular Regulation During Exercise in Humans With Chronic Kidney Disease: Sympatholysis in CKD
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: Chronic Kidney Disease
Interventions: DRUG: Sodium Bicarbonate|BEHAVIORAL: Exercise Training|DRUG: Placebo
Outcome Measures: Primary: Change in Exercise Capacity, Exercise capacity measured as VO2 peak during a maximal treadmill exercise test. Higher VO2 max indicates increased oxygen consumption and improved fitness., Baseline, Week 12 | Secondary: Change in Systolic Blood Pressure, Seated resting blood pressure is measured using an automated blood pressure monitor following American Heart Association/American College of Cardiology (AHA/ACC) technique. Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Current guidelines identify normal systolic blood pressure as lower than 120 millimeters of mercury (mmHg)., Baseline, Week 12|Change in Diastolic Blood Pressure, Seated resting blood pressure will be measured using an automated blood pressure monitor following AHA/ACC technique. Diastolic blood pressure is the amount of pressure in the arteries when the heart is at rest between beats. Current guidelines identify normal diastolic blood pressure as lower than 80 mmHg., Baseline, Week 12|Change in Muscle Sympathetic Nerve Activity (MSNA), MSNA will be measured at rest for 10 minutes using microneurography. The gold-standard method for measuring SNS activity in humans is by direct, intraneural measurements of sympathetic nerve activity via microneurography. The peroneal nerve is located with transcutaneous stimulation. A tungsten microelectrode (tip diameter 5-15um) is then inserted into the nerve, and a reference electrode is inserted 1-2 cm from the recording electrode. Nerve signals are preamplified (gain 1000), amplified (gain 50-100), filtered (700-2000 Hz), rectified, and integrated (time constant 0.1 sec) to obtain a mean voltage display of sympathetic nerve activity that is recorded. Muscle sympathetic bursts are identified by visual inspection and expressed as burst frequency (bursts per minute) and total activity (units per minute)., Baseline, Week 12|Change in Interleukin 6 (IL-6), Plasma concentration of the inflammatory biomarker IL-6 will be assessed. IL-6 is increased during injury or illness., Baseline, Week 12|Change in T2 relaxation of muscle water (T2water), T2water is a biomarker of muscle inflammation and is measured during magnetic resonance imaging (MRI). T2 relaxation of muscle water (T2water) is extracted from MRI images and is measured in milliseconds (ms)., Baseline, Week 12|Change in Lean Body Mass, Lean body mass is measured using bioimpedance. Lean body mass is assessed in kilograms (kg) and is total body weight minus body fat weight., Baseline, Week 12|Change in Exercise Pressor Reflex, The exercise pressor reflex will be measured as the change in MSNA during rhythmic handgrip exercise., Baseline, Week 12
Sponsor/Collaborators: Sponsor: Emory University | Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 156
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2022-11-11
Completion Date: 2028-06-01
Results First Posted:
Last Update Posted: 2024-09-19
Locations: Emory Clinic, Atlanta, Georgia, 30322, United States|Atlanta VA Medical Center, Decatur, Georgia, 30033, United States
URL: https://clinicaltrials.gov/show/NCT05928936