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临床试验/NCT02811835
NCT02811835进行中(未招募)不适用

Renal Sensing of the Acidifying Effect of Sulphur-containing Amino Acids: Consequences for the Relation Between Protein Intake and Blood Pressure in Renal Transplant Recipients

University Medical Center Groningen0 个研究点目标入组 1,007 人开始时间: 2008年11月最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
1,007
主要终点
Graft failure

研究概览

简要总结

Short-term (1-year) results of renal transplantation are now excellent (over 95%). Long-term (10-year and longer) results are, however, still disappointing. Where most research has focused on immunosuppression and infections, the investigators hypothesize that due to poor homeostatic capacity and necessary use of immunosuppressive and other drugs, renal transplant recipients are much more susceptible to poor dietary habits and exposure to potentially toxic contaminants than people of the general population, and that this contributes to accelerated function loss of the graft and excess risk of premature mortality, both contributing to poor long-term results. This study is a biobank and cohort study which investigates this hypothesis.

详细描述

Short-term (1-year) results of renal transplantation are now excellent (over 95%). Long-term (10-year and longer) results are, however, still disappointing. Where most research has focused on immunosuppression and infections, the investigators hypothesize that due to poor homeostatic capacity and necessary use of immunosuppressive and other drugs, renal transplant recipients are much more susceptible to poor dietary habits and exposure to potentially toxic contaminants than people of the general population, and that this contributes to accelerated function loss of the graft and excess risk of premature mortality, both contributing to poor long-term results.

To investigate one part of this overarching hypothesis, the investigators wrote a project on around the specific topic of the relation between dietary acid load, ammoniagenesis and its potential influence on blood pressure. The investigators used this project to build a biobank and cohort in which they can test additional hypotheses on the relation between diet, contaminants and development of graft failure and the occurrence of mortality.

The investigators also included 300 healthy controls to compare diet, contaminant exposure and biomarkers with the renal transplant recipients.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • More than one year after transplantation, prognosis > 1 year, stable outpatients situation -

排除标准

  • Acute illnesses, fever, current hospitalisation

结局指标

主要结局

Graft failure

时间窗: 20 years

Return to dialysis or re-transplantation

All-cause mortality

时间窗: 20 years

Death

次要结局

  • Cardiovascular mortality(20 years)
  • Cancer mortality(20 years)
  • Infectious disease mortality(20 years)

研究者

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

Stephan J.L. Bakker

Prof. dr.

University Medical Center Groningen

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