Impact of Duodena-pancreatic Transplantation on Bile Acids and Incretins Metabolism.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Bile acids composition
研究概览
简要总结
Pancreas Kidney Transplantation (PKT) is the prominent treatment for type 1 diabetic patients with chronic kidney disease and improves patients' outcome. However, in spite of an optimized systemic insulin substitution, altered glucose metabolism and beta cell function are reported in these patients. The mechanisms behind these abnormalities are still unclear. Duodena-pancreatic anastomosis is performed in a heterotopic site (ileum) and thus could change physical and chemical properties of intestinal secretions, gut flora, as well as intestinal permeability. The effect of this procedure on gut derived metabolic factors, the enterohepatic cycle of bile acids, incretin secretion and intestinal flora have never been studied. This pilot prospective, study is aimed to evaluate the modification of bile acids concentrations and composition in PKT subjects, and the impact in glucose and incretin metabolism (measured by oral glucose tolerance test) one year after transplantation. The results will be compared to those of kidney transplant patients and control subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI <30 kg/m2
- •Candidate for a first kidney transplant with a donor without the United Network for Organ Sharing (UNOS) criteria of extended donors and including living donors and pancreas-kidney donors (duodena-pancreas with ileal anastomosis and systemic drainage)
- •Patients with conventional immunosuppression (maintenance with steroids, Tacrolimus and Mycophenolate Mofetil
- •Willing and able to give informed consent
- •Control subjects :
- •Potential living kidney donor
排除标准
- •Subjects with a history of colectomy, gut resection or cholecystectomy
- •For women : pregnancy
- •Type 2 diabetes
- •Type 1 diabetes
研究组 & 干预措施
pancreas kidney transplant
Patients with pancreas kidney transplantation
干预措施: pancreas kidney transplantation (Procedure)
kidney transplant subjects
Patients with kidney transplantation
干预措施: kidney transplantation (Procedure)
Control
结局指标
主要结局
Bile acids composition
时间窗: One year after transplantation
Plasmatic bile acids composition will be assessed in serum by gas chromatography
Bile acids concentrations
时间窗: One year after transplantation
Plasmatic bile acids concentration will be measured in serum by biochemical analysis
次要结局
- Relationship between bile acid modifications and Oral Glucose Tolerance test (OGT) measures(One year after transplantation)
- Impact of Pancreas-Kidney Transplantation (PKT) on LipoPolySaccharides (LPS)(One year after transplantation)
- Impact of PKT on intestinal flora(One year)
