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Clinical Trials/NCT05353660
NCT05353660
Recruiting
Not Applicable

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

Nanfang Hospital, Southern Medical University1 site in 1 country1,000 target enrollmentApril 11, 2022

Overview

Phase
Not Applicable
Intervention
No intervention
Conditions
Chronic Kidney Diseases
Sponsor
Nanfang Hospital, Southern Medical University
Enrollment
1000
Locations
1
Primary Endpoint
sarcopenia
Status
Recruiting
Last Updated
26 days ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 11, 2022
End Date
December 31, 2027
Last Updated
26 days ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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;
  • 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

Arms & Interventions

chronic kidney disease

Intervention: No intervention

maintenance hemodialysis

Intervention: No intervention

Outcomes

Primary Outcomes

sarcopenia

Time Frame: 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

Time Frame: 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

Time Frame: 1 year

All-cause mortality is defined as the death due to any reasons.

Secondary Outcomes

  • cardiovascular events(1 year)
  • Rate of participants with hospitalization.(1 year)
  • Rate of participants with fall.(1 year)
  • CVD mortality(1 year)
  • Rate of participants with bone fracture.(1 year)
  • Change of quality of life(1 year)
  • Frailty(1 year)

Study Sites (1)

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