Clinical trial NCT05353660: Chronic Kidney Disease-related Sarcopenia With Poor Prognosis
Official title: Risk Factors of Chronic Kidney Disease-related Sarcopenia and Its Relationship With Poor Prognosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Kidney Diseases
Sarcopenia
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2022-04-29
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participants will be recruited from department of Nephrology, Nanfang Hospital

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.


Eligibility criteria: 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

Primary outcomes:
measure: sarcopenia
timeFrame: 1 year
measure: The progression of chronic kidney diseases in CKD patients
timeFrame: 1 year
measure: All-cause mortality in maintenance hemodialysis patients
timeFrame: 1 year
Secondary outcomes:
measure: CVD mortality
timeFrame: 1 year
measure: cardiovascular events
timeFrame: 1 year
measure: Rate of participants with hospitalization.
timeFrame: 1 year
measure: Rate of participants with fall.
timeFrame: 1 year
measure: Rate of participants with bone fracture.
timeFrame: 1 year
measure: Change of quality of life
timeFrame: 1 year
measure: Frailty
timeFrame: 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
state: Guangdong
Study officials:
References: