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Bile Acids and Incretins in Pancreas Kidney Transplant Patients

NCT ID: NCT02234349

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-05

Study Completion Date

2017-03-23

Brief Summary

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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.

Detailed Description

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Conditions

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Pancreas-kidney Transplantation Kidney Transplantation

Keywords

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bile acids pancreas kidney transplantation incretins intestinal flora

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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pancreas kidney transplant

Patients with pancreas kidney transplantation

Group Type EXPERIMENTAL

pancreas kidney transplantation

Intervention Type PROCEDURE

kidney transplant subjects

Patients with kidney transplantation

Group Type EXPERIMENTAL

kidney transplantation

Intervention Type PROCEDURE

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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pancreas kidney transplantation

Intervention Type PROCEDURE

kidney transplantation

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emmanuel MORELON, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

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Hôpital Edourad Herriot - Pavillon P

Lyon, , France

Site Status

Countries

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France

References

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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

Reference Type RESULT

Other Identifiers

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2012-A01517-36

Identifier Type: REGISTRY

Identifier Source: secondary_id

2012.768

Identifier Type: -

Identifier Source: org_study_id