Multimorbidity and Sarcopenia Feasibility Study in Chronic Kidney Disease

Not yet recruiting

• Conditions: Sarcopenia; Chronic Kidney Diseases
• Interventions: Diagnostic Test: Cystatin C eGFR; Other: Bioimpedance Analysis (Body composition analysis)

• Registration Number: NCT06109662
• Lead Sponsor: University Hospitals of Derby and Burton NHS Foundation Trust

Brief Summary

The aim of this research study is to look at the body composition (such as muscle and fat) in people with chronic kidney disease (CKD) and comparing it with body composition is people without CKD. The investigators currently understand loss of muscle function and mass (sarcopenia) affect the general health of people as they age, but this process seems to be more common, accelerated, and occurs earlier in people with CKD. There is limited evidence in this area, and we believe that if we understand when and how sarcopenia affects people with CKD, investigators can guide future trials and treatments to help treat sarcopenia, and in turn improve quality of life and health outcomes in people with CKD.

Detailed Description

In this study, the investigators will follow up people with CKD in two visits a year apart. In both visits, the investigators will measure the participants body composition and estimated kidney function using 2 different testing methods - Cystatin C eGFR and Creatinine eGFR. Using both the results in a formula, the creatinine muscle index can be calculated. If this index correlated with sarcopenia, it will be helpful tool in the care of people with CKD as will be a easy to use screening tool for sarcopenia in this population.

Study Timeline

• Study First Submitted: 2023-10-13
• Study First Submitted QC: 2023-10-25
• Study First Posted: 2023-10-31
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-25
• Last Update Posted: 2024-01-26
• Study Start: 2024-02
• Primary Completion: 2025-11-02
• Study Completion: 2025-11-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Subjects capable of giving informed consent

≥18 years of age Chronic kidney disease stages 3-5 looked after in secondary care nephrology Healthy volunteers with normal kidney function (Control)

Exclusion Criteria

• Pregnancy
• Subjects with known neuromuscular diseases, e.g. myopathy, muscular dystrophy, muscular atrophy
• Renal transplant recipients
• Patients with pacemakers

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chronic Kidney Disease Stage 4	Bioimpedance Analysis (Body composition analysis)	People with CKD 4 (eGFR 15-29). They will have body composition measured, and eGFR measured.
Chronic Kidney Disease Stage 3	Bioimpedance Analysis (Body composition analysis)	People with CKD Stage 3 (eGFR 30-59). They will have body composition measured, and eGFR measured.
Healthy volunteers	Bioimpedance Analysis (Body composition analysis)	Normal renal function with no kidney disease. Participants with other comorbidities can be included as long as not listed on the exclusion criteria. They will have body composition measured, and eGFR measured.
Chronic Kidney Disease Stage 4	Cystatin C eGFR	People with CKD 4 (eGFR 15-29). They will have body composition measured, and eGFR measured.
Healthy volunteers	Cystatin C eGFR	Normal renal function with no kidney disease. Participants with other comorbidities can be included as long as not listed on the exclusion criteria. They will have body composition measured, and eGFR measured.
Chronic Kidney Disease Stage 3	Cystatin C eGFR	People with CKD Stage 3 (eGFR 30-59). They will have body composition measured, and eGFR measured.
Chronic Kidney Disease Stage 5	Bioimpedance Analysis (Body composition analysis)	People with CKD 5 (eGFR \<15), but not on dialysis. They will have body composition measured, and eGFR measured.
Chronic Kidney Disease Stage 5	Cystatin C eGFR	People with CKD 5 (eGFR \<15), but not on dialysis. They will have body composition measured, and eGFR measured.

Primary Outcome Measures

Name	Time	Method
Creatinine Muscle Index (mg/day per 1.73m2)	Day 1 (day recruited) and at 1 year	Product of serum Creatinine and estimated glomerular filtration rate with Cystatin C (eGFRcys)

Secondary Outcome Measures

Name	Time	Method
Skeletal muscle mass (kg)	At Day 1 (day recruited) and 1 year	Measured by Bioimpedance analysis
Multimorbidity Score	Day 1 (day recruited) and 1 year	The Cambridge Multimorbidity Score is a UK validated index to score the comorbidities of participants. One can score from 0 to 20 on this index. Higher scores are associated with worse clinical outcomes.