Chronic Kidney Disease-related Sarcopenia With Poor Prognosis

Recruiting

• Conditions: Chronic Kidney Diseases; Sarcopenia
• Interventions: Other: No intervention

• Registration Number: NCT05353660
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-11
• Study First Submitted: 2022-04-25
• Study First Submitted QC: 2022-04-25
• Study First Posted: 2022-04-29
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-20
• Last Update Posted: 2023-09-22
• Primary Completion: 2025-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
chronic kidney disease	No intervention	-
maintenance hemodialysis	No intervention	-

Primary Outcome Measures

Name	Time	Method
sarcopenia	1 year	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
The progression of chronic kidney diseases in CKD patients	1 year	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)
All-cause mortality in maintenance hemodialysis patients	1 year	All-cause mortality is defined as the death due to any reasons.

Secondary Outcome Measures

Name	Time	Method
Rate of participants with hospitalization.	1 year	Hospitalization for any reason
Rate of participants with fall.	1 year	Rate of participants with fall.
cardiovascular events	1 year	Cardiovascular events included stroke, myocardial infarction, angina, congestive heart failure and other cardiovascular events.
CVD mortality	1 year	CVD mortality included cerebrovascular accidents, heart failure, myocardial infarction, cardiac arrest, death caused by malignant arrhythmias, and sudden death.
Rate of participants with bone fracture.	1 year	Rate of participants with bone fracture.
Change of quality of life	1 year	The quality of life is assessd by 12-item Short-Form Health Survey Questionnaire (SF-12) Survey Questionnaire (SF-12)
Frailty	1 year	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.

Trial Locations

Locations (1)

Nanfang Hospital, Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China