Islet transplantation for insulin-dependent diabetes mellitus

未提供0 个研究点目标入组 10 人开始时间: 待定最近更新: 2023年8月21日

适应症

试验速览

阶段: 不适用
状态: 招募中
入组人数: 10
主要终点: HbA1c<7.4%

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional
分配方式: Single Arm Study
干预模型: Single Assignment
主要目的: Treatment Purpose
盲法: Open(masking Not Used)

入排标准

年龄范围: 20age old over 至 75age old under（—）
性别: All

入选标准

•A patient needs insulin treatment because of significantly reduced endogenous insulin.
•Uncontrol blood glucose under the treatment by a diabetes specialist.
•Under 75 years old
•The patient, the family, and the attending physician agree with islet transplantation after the informed consent about both pancreatic transplantation and islet transplantation.
•More than 5 years have passed since the onset of the disease.

排除标准

•severe heart and/or liver disease
•alcoholism
•infection
•malignant disease
•severe obesity (BMI>25kg/m2)
•retinopathy
•other severe illness

结局指标

主要结局

HbA1c<7.4%

时间窗: a year after islet transplantation

a year after islet transplantation

percentage of recipients without hypoglycemia

时间窗: 90 to 365 days after islet transplantation

90 to 365 days after islet transplantation

次要结局

HbA1c<7.4% two year after islet transplantation and no hypoglycemia 90 to 730 days after islet transplantation(two year after islet transplantation and 90 to 730 days after islet transplantation)
no hypoglycemia 90 to 730 days after islet transplantation(90 to 730 days after islet transplantation)
HbA1c<7.4% two year after islet transplantation(two year after islet transplantation)
HbA1c<6.9% two year after islet transplantation(two year after islet transplantation)
Insulin independent two year after islet transplantation(two year after islet transplantation)

研究者

发起方

未提供

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