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临床试验/NCT02234349
NCT02234349已完成不适用

Impact of Duodena-pancreatic Transplantation on Bile Acids and Incretins Metabolism.

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2013年9月5日最近更新:
适应症
干预措施

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

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

Experimental

Patients with pancreas kidney transplantation

干预措施: pancreas kidney transplantation (Procedure)

kidney transplant subjects

Experimental

Patients with kidney transplantation

干预措施: kidney transplantation (Procedure)

Control

No Intervention

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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