Islet Transplantation in Type 1 Diabetic Patients Using a Steroid-free Immunosuppression Protocol and Thiazolidinedione Insulin Sensitizers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- number of islets necessary to achieve adequate metabolic control
研究概览
简要总结
Our hypothesis is that a successful clinical islet transplant program can be established at the University of Wisconsin using a steroid -free, sirolimus- and low dose tacrolimus - based immunosuppressive drug regimen (Edmonton protocol). We intend to answer the following research questions: 1) will treatment of islet transplant recipients with thiazolidinediones (i.e. pioglitazone) enhance post-transplant islet function and reduce the number of islets necessary to achieve adequate metabolic control? 2) which type 1 diabetic patients are optimal candidates for islet transplantation (i.e. islet transplant alone or islet after kidney transplantation)? 3) Can cadaver donor pancreases, which are ordinarily discarded and not used for pancreas transplantation be used for islet 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
- None
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
- •16 Type I insulin-dependent diabetic subjects ages 18-60,(8 who have received a prior kidney or liver transplant and have stable renal function, and 8 who have labile glucose regulation and who have failed a trial of intensive exogenous insulin therapy and who have preserved native renal function)
排除标准
- •untreated proliferative diabetic retinopathy;
- •HgbA1C >12%; creatinine clearance < 80 ml/minute or macroalbuminuria > 0.3 gm/24 hrs;
- •presence of panel reactive antibodies >20%
研究组 & 干预措施
1
Thiazolidinedione therapy
干预措施: Thiazolidinedione (Drug)
结局指标
主要结局
number of islets necessary to achieve adequate metabolic control
时间窗: 5 years
post-transplant islet function
时间窗: 5 years
次要结局
- Suitability of cadaver donor pancreases for islet transplantation(5 years)