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临床试验/NCT04515342
NCT04515342招募中不适用

Sarcopenia, Fall and Osteoporosis in Patients With Chronic Kidney Disease

Herlev Hospital2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2021年3月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
140
试验地点
2
主要终点
Difference in appendicular lean body mass

研究概览

简要总结

This study is a cross-sectional study that wishes to investigate whether there is an increased incidence of sarcopenia in patients with chronic kidney disease compared to the Danish background population. A possible association between sarcopenia and fall, as well as the incidence of osteoporosis in patients with chronic kidney disease will also be described.

详细描述

Sarcopenia is a condition diagnosed from different clinical findings such as low muscle mass, low muscle strength and possibly also poor physical performance. In the general population, the risk of fall and bone fracture increases, when sarcopenia is also present.

Sarcopenia is known to occur in patients with chronic kidney disease, but whether, and if so, how this differs from the incidence in patients without kidney disease has not previously been described.

Patients with chronic kidney disease have a 3 times higher risk of bone fracture compared to the Danish background population, and they also have an increased risk of falls.

The association between sarcopenia, risk of falls and osteoporosis in patients with kidney disease is until now sparsely described, and because of this, the investigators want to explore this further in this cross-sectional study.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
20 Years 至 120 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥20 years
  • Chronic kidney disease stage 4-5 not on dialysis (nonD) (corresponding to an estimated glomerular filtration rate (eGFR) ≤30 ml/min based on Kidney Disease Improving Global Outcomes (KDIGO) definition and not on dialysis)

排除标准

  • Kidney transplanted
  • Immobilized/hospitalized for more than 1 week within the last 6 weeks
  • Active treatment with growth hormone or sex hormone
  • Known muscle disease
  • The lack of ability to speak or understand Danish
  • The lack of ability to give an informed consent
  • The lack of ability to participate in a clinical study based on the assessment by the local investigator

结局指标

主要结局

Difference in appendicular lean body mass

时间窗: Day 0 (day of study procedure)

Difference in appendicular lean body mass between patients with chronic kidney disease and a healthy control group examined in a previous study

次要结局

  • Difference in the incidence of sarcopenia(Day 0 (day of study procedure))
  • Difference in appendicular muscle mass(Day 0 (day of study procedure))
  • Difference in handgrip strength(Day 0 (day of study procedure))
  • Difference in the incidence of osteoporosis(Day 0 (day of study procedure))
  • Difference in gait speed(Day 0 (day of study procedure))
  • Difference in sit-to-stand test(Day 0 (day of study procedure))
  • Difference in the tendency to fall(Day 0 (day of study procedure))
  • The correlation between total lean and appendicular lean body mass, handgrip strength, gait speed, sit-to-stand test, tendency to fall and osteoporosis(Day 0 (day of study procedure))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ditte Hansen

Associate professor, MD, PhD

Herlev Hospital

研究点 (2)

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