Kidney Transplantation, Pancreas-kidney Transplantation
Conditions
Keywords
bile acids, pancreas kidney transplantation, incretins, intestinal flora
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.
Interventions
PROCEDUREpancreas kidney transplantation
PROCEDUREkidney transplantation
Sponsors
Hospices Civils de Lyon
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bile acids concentrations | One year after transplantation | Plasmatic bile acids concentration will be measured in serum by biochemical analysis |
| Bile acids composition | One year after transplantation | Plasmatic bile acids composition will be assessed in serum by gas chromatography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relationship between bile acid modifications and Oral Glucose Tolerance test (OGT) measures | One year after transplantation | OGT will be performed in all subjects. Data on insulin sensitivity and secretion, Glucagon-Like Peptide 1 (GLP-1) and fibroblast growth factor-19 will be collected |
| Impact of Pancreas-Kidney Transplantation (PKT) on LipoPolySaccharides (LPS) | One year after transplantation | LPS level will be measured before transplantation and one year after transplantation |
| Impact of PKT on intestinal flora | One year | Gut microbiota will be analysed before and after transplantation |
Countries
France
Outcome results
None listed