Pancreas-kidney TransplantationITABINCT02234349
Bile Acids and Incretins in Pancreas Kidney Transplant Patients
A study testing pancreas kidney transplantation and kidney transplantation in people with Pancreas-kidney Transplantation and Kidney Transplantation, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pancreas-kidney Transplantation, Kidney Transplantation
- What is being tested?
- pancreas kidney transplantation and kidney transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 5 Sep 2013to 23 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Subjects with a history of colectomy, gut resection or cholecystectomy
- For women : pregnancy
- Type 2 diabetes
- Type 1 diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Duodena-pancreatic Transplantation on Bile Acids and Incretins Metabolism.
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.
- Being tested
- pancreas kidney transplantation, kidney transplantation
- Keywords
- bile acids, pancreas kidney transplantation, incretins, intestinal flora
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pancreas kidney transplantationProcedure or surgery
kidney transplantationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| pancreas kidney transplant | Experimental | Patients with pancreas kidney transplantation Receives: Procedure: pancreas kidney transplantation |
| kidney transplant subjects | Experimental | Patients with kidney transplantation Receives: Procedure: kidney transplantation |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bile acids concentrations
Plasmatic bile acids concentration will be measured in serum by biochemical analysis
Measured: One year after transplantation
Bile acids composition
Plasmatic bile acids composition will be assessed in serum by gas chromatography
Measured: One year after transplantation
Secondary outcomes (3)
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
Measured: One year after transplantation
Impact of Pancreas-Kidney Transplantation (PKT) on LipoPolySaccharides (LPS)
LPS level will be measured before transplantation and one year after transplantation
Measured: One year after transplantation
Impact of PKT on intestinal flora
Gut microbiota will be analysed before and after transplantation
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2014 (estimated)
- Study start5 Sep 2013
- Primary completionMar 2017
- Study completion23 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreas-kidney TransplantationStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuel MORELON, MD, PhD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02234349
- Sponsor's protocol ID
- 2012.768
- Other IDs
- 2012-A01517-36
- Acronym
- ITABI
- Status last verified
- Dec 2025
- First submitted
- 2 Sep 2014
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Duodena-pancreatic Transplantation on Bile Acids and Incretins Metabolism.
- ClinicalTrials.gov ID
- NCT02234349
- Acronym / sponsor ID
- ITABI / 2012.768
- Keywords
- bile acids, pancreas kidney transplantation, incretins, intestinal flora
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 5 Sep 2013 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- 23 Mar 2017 (actual)
- First posted
- 9 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| pancreas kidney transplant | Experimental | Procedure: pancreas kidney transplantationPatients with pancreas kidney transplantation |
| kidney transplant subjects | Experimental | Procedure: kidney transplantationPatients with kidney transplantation |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
- Potential living kidney donor
Key exclusion criteria (4 listed)
- Subjects with a history of colectomy, gut resection or cholecystectomy
- For women : pregnancy
- Type 2 diabetes
- Type 1 diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pancreas kidney transplantation | Procedure or surgery | pancreas kidney transplant |
| kidney transplantation | Procedure or surgery | kidney transplant subjects |
Primary outcome
Bile acids concentrations
Time frame: One year after transplantation
Plasmatic bile acids concentration will be measured in serum by biochemical analysis
Bile acids composition
Time frame: One year after transplantation
Plasmatic bile acids composition will be assessed in serum by gas chromatography
3 secondary outcomes
Relationship between bile acid modifications and Oral Glucose Tolerance test (OGT) measures
Time frame: One year after transplantation
Impact of Pancreas-Kidney Transplantation (PKT) on LipoPolySaccharides (LPS)
Time frame: One year after transplantation
Impact of PKT on intestinal flora
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Results publicationFitsum 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuel MORELON, MD, PhD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pancreas kidney transplantation and kidney transplantation in people with Pancreas-kidney Transplantation and Kidney Transplantation, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bile acids concentrations (time frame: One year after transplantation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02234349, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.