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Completed

NCT Number: NCT02234349

Bile Acids and Incretins in Pancreas Kidney Transplant Patients

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Edourad Herriot - Pavillon P

Lyon, 69437, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pancreas kidney transplantation

Procedure

Kidney transplantation

Procedure

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: ITABI

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Sep 9, 2014
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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