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

Civil Hospices of Lyon

Status: Completed

Conditions: Kidney Transplantation; Pancreas-kidney Transplantation

Treatments: Procedure: kidney transplantation; Procedure: pancreas kidney transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT02234349

2012-A01517-36 (Registry Identifier)

2012.768

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 3 patient groups

pancreas kidney transplant

Experimental group

Description:

Patients with pancreas kidney transplantation

Treatment:

Procedure: pancreas kidney transplantation

kidney transplant subjects

Experimental group

Description:

Patients with kidney transplantation

Treatment:

Procedure: kidney transplantation

Control

No Intervention group