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临床试验/NCT05540197
NCT05540197Enrolling By Invitation不适用

Arginine-stimulated Indication of Early Outcome After Islet Transplantation

Leiden University Medical Center1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年2月23日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
30
试验地点
1
主要终点
Early islet graft function

研究概览

简要总结

Through islet transplantation, functional β-cell mass can be restored. Allogeneic islet transplantation is a treatment modality for a select group of patients with complicated type 1 diabetes mellitus. For patients undergoing (partial) pancreas resection, autologous islet transplantation may help prevent complicated diabetes. Up until now, no studies have been performed on early islet graft function in the first week after transplantation. Early graft function may be a predictor for estimating long-term islet graft success.

Arginine can excite β-cells to release insulin. It can thus provide an estimate of β-cell secretory capacity and can be used as an alternative to (oral) glucose tolerance tests. In this study, we aim to find a predictor model for islet graft function by assessing peak C-peptide after arginine stimulus in the early post-transplantation phase.

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
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 16 years or older
  • Currently on the LUMC waiting list for allogeneic or autologous islet transplantation
  • Willing to use a flash glucose monitoring (FGM) system in the two weeks prior to transplantation

排除标准

  • Patients who are pregnant
  • Patients with known hypersensitivity to arginine

结局指标

主要结局

Early islet graft function

时间窗: Month 3

AUC C-peptide during MMTT at 3 months

次要结局

  • Beta cell graft function(Up to 3 months)
  • Treatment success(3 months)
  • Insulin concentration(Before the islet transplantation)
  • Early islet graft function(Up to 3 months)
  • Coagulation markers(Up to 3 months)
  • Insulin secretory capacity(Up to 3 months)
  • Complement factors(Up to 3 months)
  • Glycemic control(Up to 3 months)
  • Beta-cell death(Up to 3 months)
  • Immunological markers(Up to 3 months)

研究者

发起方
Leiden University Medical Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Eelco JP de Koning

Prof. Eelco de Koning

Leiden University Medical Center

研究点 (1)

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