MaSS-CKD: Multimorbidity and Sarcopenia Feasibility Study in Chronic Kidney Disease

Sponsor
University Hospitals of Derby and Burton NHS Foundation Trust (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06109662
Collaborator
(none)
80
24

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Cystatin C eGFR
  • Other: Bioimpedance Analysis (Body composition analysis)

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 Design

Study Type:
Observational
Anticipated Enrollment :
80 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Multimorbidity and Sarcopenia Feasibility Study in Chronic Kidney Disease
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Nov 2, 2025
Anticipated Study Completion Date :
Nov 2, 2025

Arms and Interventions

Arm Intervention/Treatment
Healthy volunteers

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.

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

Chronic Kidney Disease Stage 3

People with CKD Stage 3 (eGFR 30-59). They will have body composition measured, and eGFR measured.

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

Chronic Kidney Disease Stage 4

People with CKD 4 (eGFR 15-29). They will have body composition measured, and eGFR measured.

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

Chronic Kidney Disease Stage 5

People with CKD 5 (eGFR <15), but not on dialysis. They will have body composition measured, and eGFR measured.

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Skeletal muscle mass (kg) [At Day 1 (day recruited) and 1 year]

    Measured by Bioimpedance analysis

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University Hospitals of Derby and Burton NHS Foundation Trust

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospitals of Derby and Burton NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT06109662
Other Study ID Numbers:
  • 328554
First Posted:
Oct 31, 2023
Last Update Posted:
Oct 31, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 31, 2023