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临床试验/NCT05353660
NCT05353660招募中不适用

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

Nanfang Hospital, Southern Medical University1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2022年4月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
1,000
试验地点
1
主要终点
sarcopenia

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

chronic kidney disease

干预措施: No intervention (Other)

maintenance hemodialysis

干预措施: No intervention (Other)

结局指标

主要结局

sarcopenia

时间窗: 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

时间窗: 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

时间窗: 1 year

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

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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