Chronic Kidney Disease-related Sarcopenia With Poor Prognosis

Sarcopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05353660
• Other study ID #: NFEC-2022-122
• Status: Recruiting
• Start date: April 11, 2022
• Est. completion date: December 31, 2027

Study information

• Verified date: September 2023
• Source: Nanfang Hospital, Southern Medical University
• Contact: Min Liang, MD
• Phone: +86-20-61686217
• Email: nfyylm[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
China	Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital, Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	All-cause mortality in maintenance hemodialysis patients	All-cause mortality is defined as the death due to any reasons.	1 year
Secondary	CVD mortality	CVD mortality included cerebrovascular accidents, heart failure, myocardial infarction, cardiac arrest, death caused by malignant arrhythmias, and sudden death.	1 year
Secondary	cardiovascular events	Cardiovascular events included stroke, myocardial infarction, angina, congestive heart failure and other cardiovascular events.	1 year
Secondary	Rate of participants with hospitalization.	Hospitalization for any reason	1 year
Secondary	Rate of participants with fall.	Rate of participants with fall.	1 year
Secondary	Rate of participants with bone fracture.	Rate of participants with bone fracture.	1 year
Secondary	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
Secondary	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