An interventional study of pancreas kidney transplantation and kidney transplantation in Pancreas-kidney Transplantation and Kidney Transplantation, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-19.
Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Other
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.
Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients :
Control subjects :
Exclusion Criteria:
Patients with pancreas kidney transplantation
Procedure: pancreas kidney transplantation
Patients with kidney transplantation
Procedure: kidney transplantation
Bile acids concentrations
Plasmatic bile acids concentration will be measured in serum by biochemical analysis
Time frame: One year after transplantation
Bile acids composition
Plasmatic bile acids composition will be assessed in serum by gas chromatography
Time frame: One year after transplantation
Relationship between bile acid modifications and Oral Glucose Tolerance test (OGT) measures
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
Time frame: One year after transplantation
Impact of Pancreas-Kidney Transplantation (PKT) on LipoPolySaccharides (LPS)
LPS level will be measured before transplantation and one year after transplantation
Time frame: One year after transplantation
Impact of PKT on intestinal flora
Gut microbiota will be analysed before and after transplantation
Time frame: One year
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hospices Civils de Lyon