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临床试验/NCT01446302
NCT01446302已完成不适用

Metabolic and Inflammatory Responses to Hemodialysis and the Effect of a Meal

University of Aarhus4 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2011年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
4
主要终点
Changes in serum Bioactive IGF-I and IGFBP-1 levels during and after hemodialysis

研究概览

简要总结

The objective of this study is to characterize the hormonal and inflammatory responses to hemodialysis, and to determine the effect of a meal versus fast on the metabolic changes in the post-dialytic phase.

详细描述

Studies show that hemodialysis (HD) is a protein catabolic event per se and probably contributes to the high prevalence of protein-energy wasting among HD patients. The muscle catabolic effect of HD is probably caused by loss of amino acids (10-12 grams per dialysis session) and by exacerbation of the inflammatory and hormonal disorders already present. Activation of the immune system during HD has been linked to the contact of blood cells with the dialyzer membrane and to bacterial-derived DNA fragments in the dialysis fluid. An intradialytic increase in interleukin-6 (IL-6) has been shown to correlate with muscle protein catabolism, and because IL-6 continues to increase for 2 hours after HD has ended, there might be a considerable "carry-over effect" to the post-dialytic period. Moreover, HD induces significant changes in the insulin/insulin-like growth factor I (IGF-I) signaling pathways. Plasma insulin is cleared by HD, and the bioactivity of IGF-I is reduced by 50% during a 4-hr maintenance HD due to an up-regulation of IGF-binding protein 1 (IGFBP-1), the only acutely regulated IGFBP.

研究设计

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

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Changes in serum Bioactive IGF-I and IGFBP-1 levels during and after hemodialysis

时间窗: At 1, 2, 3, 5, 6, 7, 9, and 10 hours after start of hemodialysis

Changes in plasma Interleukin-6 and serum hsCRP levels during and after hemodialysis

时间窗: At 1, 2, 3, 5, 6, 7, 9, and 10 hours after start of hemodialysis

次要结局

  • Pulse wave analysis (augmentation index (AIx)) during and after hemodialysis(At 1, 2, 3, ,4, 5, 6, 7, 8, 9, and 10 hours after start of hemodialysis)
  • Mineral metabolism (including calcium, phosphate, PTH, and FGF-23 levels) during and after hemodialysis(At 1, 2, 3, 5, 6, 7, 9, and 10 hours after start of hemodialysis)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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