Multimorbidity and Sarcopenia Feasibility Study in Chronic Kidney Disease

Sarcopenia Clinical Trial

— MaSS-CKD  

Official title:

Multimorbidity and Sarcopenia Feasibility Study in Chronic Kidney Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06109662
• Other study ID #: 328554
• Status: Not yet recruiting
• Start date: February 2024
• Est. completion date: November 2, 2025

Study information

• Verified date: January 2024
• Source: University Hospitals of Derby and Burton NHS Foundation Trust
• Contact: Ashveer Randhay, BMBS
• Phone: 01332340131
• Email: ashveer.randhay[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: November 2, 2025
• Est. primary completion date: November 2, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic
• Sarcopenia

Intervention

Diagnostic Test:
• Cystatin C eGFR
Cystatin C eGFR is not used routinely currently in clinical practice in the UK. It involved a blood test to analyse Cystatin C.

Other:
• Bioimpedance Analysis (Body composition analysis)
Participants will stand on a bioimpedance analysis machine which will measure different components of body composition

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals of Derby and Burton NHS Foundation Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Creatinine Muscle Index (mg/day per 1.73m2)	Product of serum Creatinine and estimated glomerular filtration rate with Cystatin C (eGFRcys)	Day 1 (day recruited) and at 1 year
Secondary	Skeletal muscle mass (kg)	Measured by Bioimpedance analysis	At Day 1 (day recruited) and 1 year
Secondary	Multimorbidity Score	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.	Day 1 (day recruited) and 1 year