Arginine-stimulated Indication of Early Outcome After Islet Transplantation
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
- 否
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
Eelco JP de Koning
Prof. Eelco de Koning
Leiden University Medical Center
