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