Bile Acids and Incretins in Pancreas Kidney Transplant Patients (ITABI)

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

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.

Study Overview

• Status: Completed
• Conditions: Kidney Transplantation; Pancreas-kidney Transplantation
• Intervention / Treatment: Procedure: pancreas kidney transplantation; Procedure: kidney transplantation

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69437
    • Hôpital Edourad Herriot - Pavillon P

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: pancreas kidney transplant; Patients with pancreas kidney transplantation	Procedure: pancreas kidney transplantation
Experimental: kidney transplant subjects; Patients with kidney transplantation	Procedure: kidney transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bile acids concentrations	Plasmatic bile acids concentration will be measured in serum by biochemical analysis	One year after transplantation
Bile acids composition	Plasmatic bile acids composition will be assessed in serum by gas chromatography	One year after transplantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	One year after transplantation
Impact of PKT on intestinal flora	Gut microbiota will be analysed before and after transplantation	One year

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Emmanuel MORELON, MD, PhD, Hospices Civils de Lyon

Publications and helpful links

General Publications

• Fitsum Guebre-Egziabher, Pascaline Alix, Charlotte Brunelle, Christophe Sulage ROLE OF BILE ACIDS IN NEPHROTIC SYNDROME ASSOCIATED DYSLIPIDEMIA Nephrology Dialysis Transplantation, Volume 32, Issue suppl_3, May 2017, Page iii589

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2013
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 23, 2017

Study Registration Dates

• First Submitted: September 2, 2014
• First Submitted That Met QC Criteria: September 4, 2014
• First Posted (Estimated): September 9, 2014

Study Record Updates

• Last Update Posted (Estimated): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: incretins; bile acids; pancreas kidney transplantation; intestinal flora
• Additional Relevant MeSH Terms: Therapeutics; Surgical Procedures, Operative; Transplantation; Urologic Surgical Procedures; Urogenital Surgical Procedures; Renal Replacement Therapy; Organ Transplantation; Kidney Transplantation
• Other Study ID Numbers: 2012.768; 2012-A01517-36 (Registry Identifier: Agence Nationale de Sécurité du Médicament et des produits de santé)