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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02234349
Recruitment Status : Completed
First Posted : September 9, 2014
Last Update Posted : November 29, 2018
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pancreas-kidney Transplantation Kidney Transplantation Procedure: pancreas kidney transplantation Procedure: kidney transplantation Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : September 5, 2013
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 23, 2017

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Bile acids concentrations [ Time Frame: One year after transplantation ]
    Plasmatic bile acids concentration will be measured in serum by biochemical analysis

  2. Bile acids composition [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: One year after transplantation ]
    LPS level will be measured before transplantation and one year after transplantation

  3. Impact of PKT on intestinal flora [ Time Frame: One year ]
    Gut microbiota will be analysed before and after transplantation

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02234349

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Hôpital Edourad Herriot - Pavillon P
LYON cedex 03, France, 69437
Sponsors and Collaborators
Hospices Civils de Lyon
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Principal Investigator: Emmanuel MORELON, MD, PhD Hospices Civils de Lyon
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Responsible Party: Hospices Civils de Lyon Identifier: NCT02234349    
Other Study ID Numbers: 2012.768
2012-A01517-36 ( Registry Identifier: Agence Nationale de Sécurité du Médicament et des produits de santé )
First Posted: September 9, 2014    Key Record Dates
Last Update Posted: November 29, 2018
Last Verified: August 2016
Keywords provided by Hospices Civils de Lyon:
bile acids
pancreas kidney transplantation
intestinal flora
Additional relevant MeSH terms:
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Gastrointestinal Agents