Chronic kidney disease Urological and Genital Diseases Chronic kidney disease
Conditions
Interventions
This study recruits Chronic Kidney Disease (CKD) and non-CKD healthy controls, and involves up to a total of six assessment visits over a 36 month period.
30ml of venous blood is collected at baseline
Sponsors
University Hospitals of Leicester NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Kidney disease patient: 1. Established CKD according to these guidelines : http://www.gpnotebook.co.uk/simplepage.cfm?ID=x20140903131721906919 or identified with the IMPAKT tool : http://www.impakt.org.uk/HOME-459.html 2. Willing and able to give informed consent and comply with the study protocol 3. Male or female 4. Aged 18 years or above Healthy control: 1. Willing and able to give informed consent and comply with the study protocol. 2. Male or female 3. Aged 18 years or above.
Exclusion criteria
Exclusion criteria: Both kidney disease patients and healthy controls: 1. Age <18 years 2. Any other significant disease or disorder 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. 3. Inability to give informed consent or comply with the protocol for any reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Circulating markers of oxidative stress, pro/anti-inflammatory status, immune parameters and relevant genotyping are measured from a blood sample at entry and up to 5 further timepoints in a 36 month period | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Muscle and fat mass are measured using Bioelectrical Impedance Analysis at entry and up to 5 further timepoints in a 36 month period 2. Height, weight, waist and hip circumference are measured at entry and up to 5 further timepoints in a 36 month period 3. Clinical parameters (such as medications, blood and urine test results, co-morbidities, outcomes and healthcare usage) are extracted from medical records throughout the study 4. Blood markers of renal disease and co-morbidities (CVD risk, metabolic and immune function) are measured from a blood sample at entry and up to 5 further timepoints in a 36 month period 5. Urine markers of renal disease and co-morbidities (oxidative stress, microRNA expr35090ession, markers of muscle mass) are measured from a urine sample at entry and up to 5 further timepoints in a 36 month period 6. Muscle size is measured using ultrasound and muscle quality is measured using myotonometry at entry and up to 5 further timepoints in a 36 month period 7. Physical functioning is measured using the Duke Activity Status Index (DASI) at entry and up to 5 further timepoints in a 36 month period 8. CKD symptoms are measured using the Kidney Symptom Questionnaire (KSQ) at entry and up to 5 further timepoints in a 36 month period | — |
Countries
England, United Kingdom
Contacts
Public ContactAlice C Smith
Outcome results
None listed