Chronic Kidney Disease-related Sarcopenia With Poor Prognosis

Risk Factors of Chronic Kidney Disease-related Sarcopenia and Its Relationship With Poor Prognosis

Chronic kidney disease (CKD) has become a global public health priority over the past few decades, affecting 10-12% of the adult population and has received increasing attention. Sarcopenia describes a generalizes degenerative skeletal muscle disorder involving the loss of muscle mass, muscle function and/or physical performance. Indeed, Sarcopenia is a condition with many causes and it can be considered "primary sarcopenia" when no other cause is evident but ageing. While in the clinical practice, it also occurs in patients with chronic diseases, such as chronic kidney disease, which can be considered "secondary sarcopenia". Notably, the occurrence of sarcopenia in CKD patients is not only related with ageing, the accumulation of uremic toxins, inflammation, insulin resistance, malnutrition and oxidative stress also contribute to the muscle depletion. Moreover, sarcopenia increased risk of falls and fractures, impaired ability to perform activities of daily living, disabilities, loss of independence and increased risk of death. Hence, it is of great significance to prevent the occurrence and development of sarcopenia in patients with CKD. The purposes of this project were to investigate the prevalence of sarcopenia, further explore the risk factors for sarcopenia and detect the relationship between sarcopenia and outcomes in CKD patients.

Study Overview

• Status: Recruiting
• Conditions: Chronic Kidney Diseases; Sarcopenia
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Min Liang, MD; Phone Number: +86-20-61686217; Email: nfyylm@163.com
• Study Contact Backup: Name: Yaya Yang; Phone Number: +86-20-62786327; Email: yangyy0951@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Recruiting
      • Nanfang Hospital, Southern Medical University
      • Contact: Yaya Yang; Phone Number: +86-20-62786327; Email: yangyy0951@163.com
      • Contact: Min Liang, MD; Phone Number: +86-20-61686217; Email: nyyylm@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The participants will be recruited from department of Nephrology, Nanfang Hospital

Description

Inclusion Criteria:

• 1.aged ≥18 years and <80 years 2.eGFR<60ml/min/1.73m2 or had received maintenance dialysis for at least 3 months.

Exclusion Criteria:

• 1.Patients with neuromuscular diseases: such as muscular dystrophy, amyotrophic lateral sclerosis, spinal cord injury, stroke, and myasthenia gravis; 2.Patients with neurodegenerative diseases: such as Alzheimer's disease, Parkinson's disease and Huntington's disease; 3.patients with advanced malignant tumors; 4.Patients with acute infectious diseases in the past 3 months; 5. Patients with serious cardiovascular or cerebrovascular disease; 6.Moderate to severe edema; 7.Patients with rheumatoid arthritis, multiple sclerosis, or acute gout that limit joint mobility; 8.Pregnant ; 9.Patients identified to be unsuitable for enrollment by the study physician

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
chronic kidney disease	Other: No intervention; No intervention
maintenance hemodialysis	Other: No intervention; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sarcopenia	The sarcopenia is defined as: Patients with low strength: handgrip <28kg for male or <18kg for female; Or low muscle mass: appendicular skeletal muscle mass/height2 <7kg/m2 for male or <5.7kg/m2 for female; Or low performance: 6-metre walk: <1.0 m/s or 5-time chair stand test: ≥12 s	1 year
The progression of chronic kidney diseases in CKD patients	The progression of chronic kidney disease is defined as: Patients had a 50% or greater decrease in baseline eGFR <60 ml /min/1.73m2; Or end-stage renal disease (eGFR <15 ml /min/1.73m2, or initiation of renal replacement therapy)	1 year
All-cause mortality in maintenance hemodialysis patients	All-cause mortality is defined as the death due to any reasons.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CVD mortality	CVD mortality included cerebrovascular accidents, heart failure, myocardial infarction, cardiac arrest, death caused by malignant arrhythmias, and sudden death.	1 year
cardiovascular events	Cardiovascular events included stroke, myocardial infarction, angina, congestive heart failure and other cardiovascular events.	1 year
Rate of participants with hospitalization.	Hospitalization for any reason	1 year
Rate of participants with fall.	Rate of participants with fall.	1 year
Rate of participants with bone fracture.	Rate of participants with bone fracture.	1 year
Change of quality of life	The quality of life is assessd by 12-item Short-Form Health Survey Questionnaire (SF-12) Survey Questionnaire (SF-12)	1 year
Frailty	Frailty is assessed by The FRAIL Scale. The FRAIL Scale consists of five items: fatigue, resistance, ambulation, illness, and loss of weight. The scores range from 0 to 5,with 3 to 5 as frail, 1 to 2 as pre-frail, and 0 as normal.	1 year

Collaborators and Investigators

• Sponsor: Nanfang Hospital, Southern Medical University

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2022
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: April 25, 2022
• First Submitted That Met QC Criteria: April 25, 2022
• First Posted (Actual): April 29, 2022

Study Record Updates

• Last Update Posted (Actual): September 22, 2023
• Last Update Submitted That Met QC Criteria: September 20, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Urologic Diseases; Neurologic Manifestations; Disease Attributes; Renal Insufficiency; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Sarcopenia
• Other Study ID Numbers: NFEC-2022-122

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data will be available from the corresponding author upon request, after the request is submitted and formally reviewed and approved by the Ethics Committee of Nanfang Hospital.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No