Metabolic Studies in Type 1 Diabetic Patients After Allogenic Intraportal Islet Transplantation.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Whole body glucose counterregulation
研究概览
简要总结
Pancreatic islet transplantation improves glucose counterregulation and stabilizes glycemic control in patients with type 1 diabetes mellitus prone to severe hypoglycemia even if insulin independence is not achieved. However, the extent and underlying metabolic pathways of this improvement are unknown. Investigators therefore compare systemic glucose turnover including lactate gluconeogenesis and muscle glucose utilization, between insulin-requiring islet transplant recipients, matched type 1 diabetic subjects who did not receive islet transplantation, and matched healthy non-diabetic subjects.
详细描述
Subjects (n=12 each group) undergo a hypoglycemic and a euglycemic hyperinsulinemic clamp in a randomized fashion. Systemic and skeletal muscle glucose and lactate kinetics are assessed using a combination of isotopic and forearm balance techniques.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Type 1 Diabetes
- •Pancreatic islet transplantation
排除标准
- •Type 2 Diabetes
结局指标
主要结局
Whole body glucose counterregulation
时间窗: 6-8 weeks
Whole body glucose counterregulation is the difference in glucose infusion rates required to maintain the glycemic goal between the hypoglycemic and euglycemic clamp. Clamps were performed at two time points at least two weeks apart. Participants will be followed for the duration of 6-8 weeks to perform the hypoglycemic and euglycemic clamp tests.
次要结局
- Systemic glucose release(6-8 weeks)
- Skeletal muscle glucose disposal(6-8 weeks)
- Gluconeogenesis from lactate(6-8 weeks)
研究者
Thomas Linn
Professor Dr. med.
University of Giessen