Clinical trial NCT02234349: Bile Acids and Incretins in Pancreas Kidney Transplant Patients
Official title: Impact of Duodena-pancreatic Transplantation on Bile Acids and Incretins Metabolism.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreas-kidney Transplantation
Kidney Transplantation
Keywords: bile acids
pancreas kidney transplantation
incretins
intestinal flora
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2014-09-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

Patients :

* 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

Exclusion Criteria:

* Subjects with a history of colectomy, gut resection or cholecystectomy
* For women : pregnancy
* Type 2 diabetes
* Type 1 diabetes

Primary outcomes:
measure: Bile acids concentrations
timeFrame: One year after transplantation
measure: Bile acids composition
timeFrame: One year after transplantation
Secondary outcomes:
measure: Relationship between bile acid modifications and Oral Glucose Tolerance test (OGT) measures
timeFrame: One year after transplantation
measure: Impact of Pancreas-Kidney Transplantation (PKT) on LipoPolySaccharides (LPS)
timeFrame: One year after transplantation
measure: Impact of PKT on intestinal flora
timeFrame: One year
Other outcomes:
Locations:
city: LYON cedex 03
country: France
facility: Hôpital Edourad Herriot - Pavillon P
Study officials:
affiliation: Hospices Civils de Lyon
name: Emmanuel MORELON, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: