ITABI: Bile Acids and Incretins in Pancreas Kidney Transplant Patients

• Sponsor: Hospices Civils de Lyon (Other)
• Overall Status: Completed
• CT.gov ID: NCT02234349
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 3
• Actual Duration (Months): 42.5
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreas-kidney Transplantation; Kidney Transplantation	Procedure: pancreas kidney transplantation; Procedure: kidney transplantation	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Impact of Duodena-pancreatic Transplantation on Bile Acids and Incretins Metabolism.
• Actual Study Start Date: Sep 5, 2013
• Actual Primary Completion Date: Mar 1, 2017
• Actual Study Completion Date: Mar 23, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Bile acids concentrations [One year after transplantation]

   Plasmatic bile acids concentration will be measured in serum by biochemical analysis

2. Bile acids composition [One year after transplantation]

   Plasmatic bile acids composition will be assessed in serum by gas chromatography

Secondary Outcome Measures

1. 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

2. 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

3. Impact of PKT on intestinal flora [One year]

   Gut microbiota will be analysed before and after transplantation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Edourad Herriot - Pavillon P	LYON cedex 03		France	69437

Sponsors and Collaborators

• Hospices Civils de Lyon

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hospices Civils de Lyon
• ClinicalTrials.gov Identifier: NCT02234349
• Other Study ID Numbers: 2012.768; 2012-A01517-36
• First Posted: Sep 9, 2014
• Last Update Posted: Nov 29, 2018
• Last Verified: Aug 1, 2016

• Keywords provided by Hospices Civils de Lyon: bile acids; pancreas kidney transplantation; incretins; intestinal flora
• Additional relevant MeSH terms: Pancrelipase

Study Results

No Results Posted as of Nov 29, 2018