Chronic kidney disease Urological and Genital Diseases Renal disorders
Conditions
Interventions
This study has 2 separate parts A and B. Part A is a survey. Part B is a single-centre observational/exploratory study involving up to 4 visits over approximately two weeks.
Part A:
Participants wit
Sponsors
University Hospitals of Leicester NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient inclusion criteria: Diagnosed CKD patients (eGFR 80 ml/min/1.73 m2). All participants must be willing and able to give informed consent for participation in the study.
Exclusion criteria
Exclusion criteria: Patient exclusion criteria: 1. Age <18 years 2. Female participants who are pregnant, lactating, or planning pregnancy during the course of the study 3. Scheduled elective surgery or other procedures requiring general anaesthesia during the study 4. Any other significant disease or disorder (i.e., significant co-morbidity including unstable hypertension, potentially lethal arrhythmia, myocardial infarction within 6 months, unstable angina, active liver disease, uncontrolled diabetes mellitus (HbA1c =9%), advanced cerebral or peripheral vascular disease) which, in the opinion of the patient’s own clinician, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study 5. Inability to give informed consent or comply with testing and training protocol for any reason 6. Individuals who are currently, or have in the past 6 months, used immunosuppressive or anti-inflammatory medication other than that required by renal transplant recipients (RTRs) to prevent graft rejection Healthy control exclusion criteria: 1. Age <18 years 2. Female participants who are pregnant, lactating, or planning pregnancy during the course of the study 3. Scheduled elective surgery or other procedures requiring general anaesthesia during the study 4. Chronic Kidney Disease (eGFR <80 ml/min/1.73 m2) 5. Any other significant disease or disorder (i.e., significant co-morbidity including unstable hypertension, potentially lethal arrhythmia, myocardial infarction within 6 months, unstable angina, active liver disease, uncontrolled diabetes mellitus (HbA1c =9%), advanced cerebral or peripheral vascular disease) 6. Individuals who are currently, or have in the past 6 months, used immunosuppressive medication 7. Inability to give informed consent for any reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immune cell populations and phenotype, inflammation, anabolic and catabolic processes, myogenesis and expression of proteins important in the maintenance of muscle mass using flow cytometry, PCR, western blotting and immuno-fluorescent staining is measured using the muscle biopsy samples at baseline, 4 hours post and 48 hours post exercise. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Metabolic and immune function is measured using blood samples at baseline, 4 hours post and 48 hours post exercise 2. Inflammation is measured using blood samples at baseline, 4 hours post and 48 hours post exercise 3. Proteins related to the maintenance of muscle mass are measured using blood samples at baseline, 4 hours post and 48 hours post exercise 4. Oxidative stress is measured using blood samples at baseline, 4 hours post and 48 hours post exercise 5. Immune function is measured using saliva at baseline, 4 hours post and 48 hours post exercise 6. Relationships between muscle wasting, levels of physical activity, physical function and symptoms perceptions are measured using questionnaire responses at baseline, 4 hours post and 48 hours post exercise | — |
Countries
England, United Kingdom
Outcome results
None listed