Hôpital Edourad Herriot - Pavillon P
Lyon, 69437, France
NCT Number: NCT02234349
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.
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Notify Me18 year–55 year
All sexes
Interventional
Not applicable
Lyon, 69437, France
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients :
Control subjects :
Exclusion criteria
Time frame: One year after transplantation
Plasmatic bile acids concentration will be measured in serum by biochemical analysis
Time frame: One year after transplantation
Plasmatic bile acids composition will be assessed in serum by gas chromatography
Time frame: 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
Time frame: One year after transplantation
LPS level will be measured before transplantation and one year after transplantation
Time frame: One year
Gut microbiota will be analysed before and after transplantation
Hospices Civils de Lyon
Other
Impact of Duodena-pancreatic Transplantation on Bile Acids and Incretins Metabolism.
Acronym: ITABI
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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