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Bile Acids and Incretins in Pancreas Kidney Transplant Patients (ITABI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02234349
Recruitment Status : Completed
First Posted : September 9, 2014
Last Update Posted : November 29, 2018
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Tracking Information
First Submitted Date  ICMJE September 2, 2014
First Posted Date  ICMJE September 9, 2014
Last Update Posted Date November 29, 2018
Actual Study Start Date  ICMJE September 5, 2013
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 4, 2014)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 4, 2014)
  • 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
  • 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
  • Impact of PKT on intestinal flora [ Time Frame: One year ]
    Gut microbiota will be analysed before and after transplantation
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bile Acids and Incretins in Pancreas Kidney Transplant Patients
Official Title  ICMJE Impact of Duodena-pancreatic Transplantation on Bile Acids and Incretins Metabolism.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Pancreas-kidney Transplantation
  • Kidney Transplantation
Intervention  ICMJE
  • Procedure: pancreas kidney transplantation
  • Procedure: kidney transplantation
Study Arms  ICMJE
  • Experimental: pancreas kidney transplant
    Patients with pancreas kidney transplantation
    Intervention: Procedure: pancreas kidney transplantation
  • Experimental: kidney transplant subjects
    Patients with kidney transplantation
    Intervention: Procedure: kidney transplantation
  • No Intervention: Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 4, 2014)
50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 23, 2017
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02234349
Other Study ID Numbers  ICMJE 2012.768
2012-A01517-36 ( Registry Identifier: Agence Nationale de Sécurité du Médicament et des produits de santé )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hospices Civils de Lyon
Study Sponsor  ICMJE Hospices Civils de Lyon
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Emmanuel MORELON, MD, PhD Hospices Civils de Lyon
PRS Account Hospices Civils de Lyon
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP