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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-A01517-36 | Registry Identifier | Agence Nationale de Sécurité du Médicament et des produits de santé |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pancreas kidney transplant | Experimental | Patients with pancreas kidney transplantation |
|
| kidney transplant subjects | Experimental | Patients with kidney transplantation |
|
| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pancreas kidney transplantation | Procedure |
| ||
| kidney transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | One year after transplantation |
| Impact of Pancreas-Kidney Transplantation (PKT) on LipoPolySaccharides (LPS) |
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Inclusion Criteria:
Patients :
Control subjects :
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emmanuel MORELON, MD, PhD | Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Edourad Herriot - Pavillon P | Lyon | 69437 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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 |
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| ID | Term |
|---|---|
| D016030 | Kidney Transplantation |
| ID | Term |
|---|---|
| D017582 | Renal Replacement Therapy |
| D013812 | Therapeutics |
| D016377 | Organ Transplantation |
| D014180 | Transplantation |
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| Procedure |
|
LPS level will be measured before transplantation and one year after transplantation |
| One year after transplantation |
| Impact of PKT on intestinal flora | Gut microbiota will be analysed before and after transplantation | One year |
| D013514 |
| Surgical Procedures, Operative |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |