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临床试验/NCT01123122
NCT01123122撤回不适用

A Comparison of Strict Glucose Control With Usual Care at the Time of Islet Cell Transplantation

Vancouver Coastal Health2 个研究点 分布在 1 个国家开始时间: 2011年9月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Islet cell function

研究概览

简要总结

Islet transplants for those with type 1 diabetes have enabled many to initially eliminate insulin, however, only a fraction of the transplanted cells typically survive and the functioning of these decrease over time. As a result, most patients will eventually require some insulin. Currently, the cause of this poor survival and decrease in function is not understood; although previous research has demonstrated that even a slightly elevated level of blood glucose can impair islet function. This study will determine if strict blood glucose control at the time of islet transplantation, when the cells are the most fragile, will improve the survival and functioning of transplanted islet cells three months after transplantation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 to 65 years of age
  • more than 5 years since diagnosis of diabetes
  • c-peptide negative

排除标准

  • ischemic heart disease
  • previous transplant
  • recurrent infections
  • malignancy (except basal or squamous skin cancer)

结局指标

主要结局

Islet cell function

时间窗: Three months

Function will be assessed three months post-transplantation.

次要结局

未报告次要终点

研究者

申办方类型
Other Gov

研究点 (2)

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