Bile Acids and Incretins in Pancreas Kidney Transplant Patients

Kidney Transplantation Clinical Trial

— ITABI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02234349
• Other study ID #: 2012.768
• Secondary ID: 2012-A01517-36
• Status: Completed
• Phase: N/A
• Start date: September 5, 2013
• Est. completion date: March 23, 2017

Study information

• Verified date: August 2016
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 23, 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Kidney Transplantation
• Pancreas-kidney Transplantation

Intervention

Procedure:
• pancreas kidney transplantation

• kidney transplantation

Locations

Country	Name	City	State
France	Hôpital Edourad Herriot - Pavillon P	LYON cedex 03

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bile acids concentrations	Plasmatic bile acids concentration will be measured in serum by biochemical analysis	One year after transplantation
Primary	Bile acids composition	Plasmatic bile acids composition will be assessed in serum by gas chromatography	One year after transplantation
Secondary	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
Secondary	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
Secondary	Impact of PKT on intestinal flora	Gut microbiota will be analysed before and after transplantation	One year