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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
First received
Last updated
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
Health authority
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

Study Design


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
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