<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02234349</url>
  </required_header>
  <id_info>
    <org_study_id>2012.768</org_study_id>
    <secondary_id>2012-A01517-36</secondary_id>
    <nct_id>NCT02234349</nct_id>
  </id_info>
  <brief_title>Bile Acids and Incretins in Pancreas Kidney Transplant Patients</brief_title>
  <acronym>ITABI</acronym>
  <official_title>Impact of Duodena-pancreatic Transplantation on Bile Acids and Incretins Metabolism.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pancreas Kidney Transplantation (PKT) is the prominent treatment for type 1 diabetic patients&#xD;
      with chronic kidney disease and improves patients' outcome. However, in spite of an optimized&#xD;
      systemic insulin substitution, altered glucose metabolism and beta cell function are reported&#xD;
      in these patients. The mechanisms behind these abnormalities are still unclear.&#xD;
      Duodena-pancreatic anastomosis is performed in a heterotopic site (ileum) and thus could&#xD;
      change physical and chemical properties of intestinal secretions, gut flora, as well as&#xD;
      intestinal permeability. The effect of this procedure on gut derived metabolic factors, the&#xD;
      enterohepatic cycle of bile acids, incretin secretion and intestinal flora have never been&#xD;
      studied. This pilot prospective, study is aimed to evaluate the modification of bile acids&#xD;
      concentrations and composition in PKT subjects, and the impact in glucose and incretin&#xD;
      metabolism (measured by oral glucose tolerance test) one year after transplantation. The&#xD;
      results will be compared to those of kidney transplant patients and control subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 5, 2013</start_date>
  <completion_date type="Actual">March 23, 2017</completion_date>
  <primary_completion_date type="Actual">March 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Bile acids concentrations</measure>
    <time_frame>One year after transplantation</time_frame>
    <description>Plasmatic bile acids concentration will be measured in serum by biochemical analysis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Bile acids composition</measure>
    <time_frame>One year after transplantation</time_frame>
    <description>Plasmatic bile acids composition will be assessed in serum by gas chromatography</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Relationship between bile acid modifications and Oral Glucose Tolerance test (OGT) measures</measure>
    <time_frame>One year after transplantation</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of Pancreas-Kidney Transplantation (PKT) on LipoPolySaccharides (LPS)</measure>
    <time_frame>One year after transplantation</time_frame>
    <description>LPS level will be measured before transplantation and one year after transplantation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of PKT on intestinal flora</measure>
    <time_frame>One year</time_frame>
    <description>Gut microbiota will be analysed before and after transplantation</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Pancreas-kidney Transplantation</condition>
  <condition>Kidney Transplantation</condition>
  <arm_group>
    <arm_group_label>pancreas kidney transplant</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with pancreas kidney transplantation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>kidney transplant subjects</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with kidney transplantation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>pancreas kidney transplantation</intervention_name>
    <arm_group_label>pancreas kidney transplant</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>kidney transplantation</intervention_name>
    <arm_group_label>kidney transplant subjects</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients :&#xD;
&#xD;
          -  BMI &lt;30 kg/m2&#xD;
&#xD;
          -  Candidate for a first kidney transplant with a donor without the United Network for&#xD;
             Organ Sharing (UNOS) criteria of extended donors and including living donors and&#xD;
             pancreas-kidney donors (duodena-pancreas with ileal anastomosis and systemic drainage)&#xD;
&#xD;
          -  Patients with conventional immunosuppression (maintenance with steroids, Tacrolimus&#xD;
             and Mycophenolate Mofetil&#xD;
&#xD;
          -  Willing and able to give informed consent&#xD;
&#xD;
        Control subjects :&#xD;
&#xD;
          -  Potential living kidney donor&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with a history of colectomy, gut resection or cholecystectomy&#xD;
&#xD;
          -  For women : pregnancy&#xD;
&#xD;
          -  Type 2 diabetes&#xD;
&#xD;
          -  Type 1 diabetes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Emmanuel MORELON, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospices Civils de Lyon</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpital Edourad Herriot - Pavillon P</name>
      <address>
        <city>LYON cedex 03</city>
        <zip>69437</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>September 2, 2014</study_first_submitted>
  <study_first_submitted_qc>September 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <last_update_submitted>November 28, 2018</last_update_submitted>
  <last_update_submitted_qc>November 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 29, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>bile acids</keyword>
  <keyword>pancreas kidney transplantation</keyword>
  <keyword>incretins</keyword>
  <keyword>intestinal flora</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancrelipase</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02234349
org study id: 2012.768
secondary id: 2012-A01517-36
nct id: NCT02234349
lead sponsor: 
has dmc: No
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Bile acids concentrations
time frame: One year after transplantation
description: Plasmatic bile acids concentration will be measured in serum by biochemical analysis
measure: Bile acids composition
time frame: One year after transplantation
description: Plasmatic bile acids composition will be assessed in serum by gas chromatography
measure: Relationship between bile acid modifications and Oral Glucose Tolerance test (OGT) measures
time frame: One year after transplantation
description: 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
measure: Impact of Pancreas-Kidney Transplantation (PKT) on LipoPolySaccharides (LPS)
time frame: One year after transplantation
description: LPS level will be measured before transplantation and one year after transplantation
measure: Impact of PKT on intestinal flora
time frame: One year
description: Gut microbiota will be analysed before and after transplantation
arm group label: pancreas kidney transplant
arm group type: Experimental
description: Patients with pancreas kidney transplantation
arm group label: kidney transplant subjects
arm group type: Experimental
description: Patients with kidney transplantation
arm group label: Control
arm group type: No Intervention
intervention type: Procedure
intervention name: pancreas kidney transplantation
arm group label: pancreas kidney transplant
intervention type: Procedure
intervention name: kidney transplantation
arm group label: kidney transplant subjects
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Emmanuel MORELON, MD, PhD
role: Principal Investigator
affiliation: Hospices Civils de Lyon
facility: 
country: France
responsible party type: Sponsor
mesh term: Pancrelipase