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临床试验/NCT03272854
NCT03272854进行中(未招募)不适用

TransplantLines Insulin Resistance and Inflammation Biobank and Cohort Study

University Medical Center Groningen0 个研究点目标入组 606 人开始时间: 2001年8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
606
主要终点
All-Cause Mortality

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 in renal transplant recipient, amongst others overweight, obesity, chronic use of immunosuppressive drugs and impaired renal function contribute to insulin resistance and chronic low-grade inflammation, which pose the renal transplant recipients at increased risk for cardiovascular disease, decline of function of the transplanted kidney and other complications, including post-transplant diabetes. 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 in renal transplant recipient, amongst others overweight, obesity, chronic use of immunosuppressive drugs and impaired renal function contribute to insulin resistance and chronic low-grade inflammation, which pose the renal transplant recipients at increased risk for cardiovascular disease, decline of function of the transplanted kidney and other complications, including post-transplant diabetes. To investigate this hypothesis we have detailedly phenotyped 606 renal transplant recipients who at the time of inclusion all were one year or more after transplantation, therewith providing a representation of stable outpatient renal trannsplant recipients late after renal transplantation. At the time of these baseline measurements, we also created a biobank with plasma, serum and aliquots of 24h urine collections. Beyond baseline, we have a regular update on adverse events, including all-cause mortality, cause-specific mortality, graft failure and development of new-onset diabetes after transplantation (NODAT).

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 renal transplantation
  • History of renal transplantation

排除标准

  • Signs of active infection
  • Signs of active cardiac decompensation
  • Active malignancy other than skin cancer
  • Prognosis < 1 year

结局指标

主要结局

All-Cause Mortality

时间窗: 30 years

All-Cause Mortality

Graft Failure

时间窗: 30 years

Death-Censored Graft Failure

次要结局

  • New Onset Diabetes After Transplantation(30 years)
  • Cardiovascular Mortality(30 years)
  • Non-Cardiovascular Mortality(30 years)

研究者

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

Stephan J.L. Bakker

Internist-Neprologist

University Medical Center Groningen

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