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临床试验/NCT02794142
NCT02794142终止不适用

Impact of the Oxidative Stress on the Skeletal Muscle Dysfunction in Hemodialysis Patient

University Hospital, Montpellier2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2015年5月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
32
试验地点
2
主要终点
Muscle mitochondrial density assessed on a quadriceps biopsy by immunochemistry

研究概览

简要总结

In hemodialysis patient (HD) a reduction of the skeletal muscle mass and strength has previously been reported. This muscle impairment constitutes an independent prognosis factor in HD patients. Oxidative stress and inflammation have been linked to the muscle impairment. The mitochondria is a classical producer and target of reactive oxygen species (ROS), and may thus constitute a central actor of the skeletal muscle impairment in HD patients. Therefore, the aim of the present study is to investigate the role of the muscle mitochondrial density on the muscle impairment in HD patients, in comparing the muscle mitochondrial density and oxidative stress in HD patients vs. healthy matched controls.

In order to assess the effect of the oxidative stress and inflammation on the muscle impairment in HD patients, muscle function assessements will be performed after renal transplantation (which lowers the oxidative stress and inflammation levels) in the HD patient group.

No therapeutic intervention will be tested in the present study.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

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

入选标准

  • Age between 40-80 years old
  • less than 150min by week of moderate to vigorous physical activity
  • Chronic renal failure (glomerular filtration rate less than 15mL by min) requiring hemodialysis
  • Patient placed on the kidney transplant waiting list of MontpellierCHU
  • No indication against temporary kidney transplant
  • Review cardiovascular older than two years
  • Patient not under guardianship or trusteeship
  • Clinically stable state Absence or recent infection within 3 months prior to inclusion Absence of progressive neoplasia No recent acute decompensation of chronic disease (thrust of heart failure, respiratory decompensated cirrhosis).
  • Absence of recent stroke
  • musculoskeletal and neurological states of the lower limbs which allow the realization of the proposed functional tests.
  • Patient has given written informed consent
  • Absence of congenital or genetic degenerative muscle disease

排除标准

  • Terminal chronic renal failure without replacement therapy
  • Local anesthesic hypersensibility
  • Corticosteroid treatment upper than 3 month
  • Oral anticoagulants
  • Previous renal transplantation
  • Subject not affiliated with a social security scheme, beneficiary or not such a plan
  • Major subject protected by law or unable to consent under Article L 1121-8 of the Public Health Code
  • Vulnerable person under Article L.1121-6 of the Public Health Code

结局指标

主要结局

Muscle mitochondrial density assessed on a quadriceps biopsy by immunochemistry

时间窗: 2 years

次要结局

  • Maximum voluntary contraction of the quadriceps (in Newton.meter)(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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