Bile Acids and Incretins in Pancreas Kidney Transplant Patients

Not Applicable

Completed

• Conditions: Pancreas-kidney Transplantation; Kidney Transplantation
• Interventions: Procedure: pancreas kidney transplantation; Procedure: kidney transplantation

• Registration Number: NCT02234349
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-05
• Study First Submitted: 2014-09-02
• Study First Submitted QC: 2014-09-04
• Study First Posted: 2014-09-09
• Status Verified: 2016-08
• Primary Completion: 2017-03
• Study Completion: 2017-03-23
• Last Update Submitted: 2018-11-28
• Last Update Posted: 2018-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pancreas kidney transplant	pancreas kidney transplantation	Patients with pancreas kidney transplantation
kidney transplant subjects	kidney transplantation	Patients with kidney transplantation

Primary Outcome Measures

Name	Time	Method
Bile acids composition	One year after transplantation	Plasmatic bile acids composition will be assessed in serum by gas chromatography
Bile acids concentrations	One year after transplantation	Plasmatic bile acids concentration will be measured in serum by biochemical analysis

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hôpital Edourad Herriot - Pavillon P; 🇫🇷 LYON cedex 03, France