NCT02234349

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 5, 2013

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 9, 2014

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2017

Completed
Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

3.5 years

First QC Date

September 2, 2014

Last Update Submit

December 13, 2025

Conditions

Pancreas-kidney TransplantationKidney Transplantation

Keywords

bile acidspancreas kidney transplantationincretinsintestinal flora

Outcome Measures

Primary Outcomes (2)

  • Bile acids concentrations

    Plasmatic bile acids concentration will be measured in serum by biochemical analysis

    One year after transplantation

  • Bile acids composition

    Plasmatic bile acids composition will be assessed in serum by gas chromatography

    One year after transplantation

Secondary Outcomes (3)

  • Relationship between bile acid modifications and Oral Glucose Tolerance test (OGT) measures

    One year after transplantation

  • Impact of Pancreas-Kidney Transplantation (PKT) on LipoPolySaccharides (LPS)

    One year after transplantation

  • Impact of PKT on intestinal flora

    One year

Study Arms (3)

pancreas kidney transplant

EXPERIMENTAL

Patients with pancreas kidney transplantation

Procedure: pancreas kidney transplantation

kidney transplant subjects

EXPERIMENTAL

Patients with kidney transplantation

Procedure: kidney transplantation

Control

NO INTERVENTION

Interventions

kidney transplantationPROCEDURE
kidney transplant subjects
pancreas kidney transplantationPROCEDURE
pancreas kidney transplant

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Subjects with a history of colectomy, gut resection or cholecystectomy
  • For women : pregnancy
  • Type 2 diabetes
  • Type 1 diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Edourad Herriot - Pavillon P

Lyon, 69437, France

Location

Related Publications (1)

  • Fitsum Guebre-Egziabher, Pascaline Alix, Charlotte Brunelle, Christophe Sulage ROLE OF BILE ACIDS IN NEPHROTIC SYNDROME ASSOCIATED DYSLIPIDEMIA Nephrology Dialysis Transplantation, Volume 32, Issue suppl_3, May 2017, Page iii589

    RESULT

MeSH Terms

Interventions

Kidney Transplantation

Intervention Hierarchy (Ancestors)

Renal Replacement TherapyTherapeuticsOrgan TransplantationTransplantationSurgical Procedures, OperativeUrologic Surgical ProceduresUrogenital Surgical Procedures

Study Officials

  • Emmanuel MORELON, MD, PhD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2014

First Posted

September 9, 2014

Study Start

September 5, 2013

Primary Completion

March 1, 2017

Study Completion

March 23, 2017

Last Updated

December 19, 2025

Record last verified: 2025-12

Locations

FR(1)