<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/NCT02261831</url>
  </required_header>
  <id_info>
    <org_study_id>13 6936 03</org_study_id>
    <nct_id>NCT02261831</nct_id>
  </id_info>
  <brief_title>Identify Bacteria Associated With Metabolic Diseases That Reside Both in Intestinal Crypts and in Blood</brief_title>
  <acronym>MICIMAB</acronym>
  <official_title>Identify Bacteria Associated With Metabolic Diseases That Reside Both in Intestinal Crypts and in Blood.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Toulouse</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Toulouse</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators will compare 16sRDNA profile in cases and controls in order to identify&#xD;
      bacteria associated with metabolic diseases that reside both in intestinal crypts and in&#xD;
      blood.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Experimental evidence suggests that bacterial translocation from gut to tissue could be an&#xD;
      initial step leading to diabetes. To test this hypothesis, a bacterial component that is&#xD;
      highly conserved between different species of bacteria, the 16S rDNA gene will be analysed&#xD;
      both in intestinal crypt and in blood in patients with type 2 diabetes, obese patients and&#xD;
      control.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2014</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">December 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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>rDNA comparison between cases and controls</measure>
    <time_frame>36 months</time_frame>
    <description>Comparison of 16sRDNA profile in cases and controls in order to identify bacteria associated with metabolic diseases that reside both in intestinal crypts and in blood.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">99</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>obese patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Total blood sample, and 4 biopsies : collection of 2 colonic and 2 ileal biopsies</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Diabetic patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Total blood sample, and 4 biopsies : collection of 2 colonic and 2 ileal biopsies</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients free of obesity and diabetes</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Total blood sample, and 4 biopsies : collection of 2 colonic and 2 ileal biopsies</description>
  </arm_group>
  <arm_group>
    <arm_group_label>patients free type 2 diabetes.</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Total blood sample, and 4 biopsies : collection of 2 colonic and 2 ileal biopsies</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>obese patients</intervention_name>
    <description>collection of blood sampling and biopsies</description>
    <arm_group_label>obese patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>diabetic patients</intervention_name>
    <description>collection of blood sampling and biopsies</description>
    <arm_group_label>Diabetic patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>patients free of obesity and diabetes</intervention_name>
    <description>collection of blood sampling and biopsies</description>
    <arm_group_label>Patients free of obesity and diabetes</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>patients free type 2 diabetes</intervention_name>
    <description>collection of blood sampling and biopsies</description>
    <arm_group_label>patients free type 2 diabetes.</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Between 35 and 75 years old&#xD;
&#xD;
          -  Colonoscopy and biopsies required&#xD;
&#xD;
        Diabetes population:&#xD;
&#xD;
          -  Type 2 diabetes&#xD;
&#xD;
        Obese population:&#xD;
&#xD;
          -  Android obesity&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inflammatory bowel disease&#xD;
&#xD;
          -  Colonic cancer&#xD;
&#xD;
          -  Bariatric surgery&#xD;
&#xD;
          -  Previous administration of antibiotic (within 15 days)&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jacques AMAR, MD PhD</last_name>
    <role>Study Director</role>
    <affiliation>CHU Toulouse</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jacques Moreau, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Toulouse</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital of Toulouse</name>
      <address>
        <city>Toulouse</city>
        <zip>31 052</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>July 22, 2014</study_first_submitted>
  <study_first_submitted_qc>October 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2014</study_first_posted>
  <last_update_submitted>November 29, 2018</last_update_submitted>
  <last_update_submitted_qc>November 29, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>bacterial</keyword>
  <keyword>gut</keyword>
  <keyword>type 2 diabetes.</keyword>
  <keyword>16S rDNA gene</keyword>
  <keyword>intestinal crypt</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metabolic Diseases</mesh_term>
  </condition_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/NCT02261831
org study id: 13 6936 03
nct id: NCT02261831
lead sponsor: 
has dmc: No
The investigators will compare 16sRDNA profile in cases and controls in order to identify
      bacteria associated with metabolic diseases that reside both in intestinal crypts and in
      blood.
Experimental evidence suggests that bacterial translocation from gut to tissue could be an
      initial step leading to diabetes. To test this hypothesis, a bacterial component that is
      highly conserved between different species of bacteria, the 16S rDNA gene will be analysed
      both in intestinal crypt and in blood in patients with type 2 diabetes, obese patients and
      control.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: rDNA comparison between cases and controls
time frame: 36 months
description: Comparison of 16sRDNA profile in cases and controls in order to identify bacteria associated with metabolic diseases that reside both in intestinal crypts and in blood.
arm group label: obese patients
arm group type: Experimental
description: Total blood sample, and 4 biopsies : collection of 2 colonic and 2 ileal biopsies
arm group label: Diabetic patients
arm group type: Experimental
description: Total blood sample, and 4 biopsies : collection of 2 colonic and 2 ileal biopsies
arm group label: Patients free of obesity and diabetes
arm group type: Experimental
description: Total blood sample, and 4 biopsies : collection of 2 colonic and 2 ileal biopsies
arm group label: patients free type 2 diabetes.
arm group type: Experimental
description: Total blood sample, and 4 biopsies : collection of 2 colonic and 2 ileal biopsies
intervention type: Other
intervention name: obese patients
description: collection of blood sampling and biopsies
arm group label: obese patients
intervention type: Other
intervention name: diabetic patients
description: collection of blood sampling and biopsies
arm group label: Diabetic patients
intervention type: Other
intervention name: patients free of obesity and diabetes
description: collection of blood sampling and biopsies
arm group label: Patients free of obesity and diabetes
intervention type: Other
intervention name: patients free type 2 diabetes
description: collection of blood sampling and biopsies
arm group label: patients free type 2 diabetes.
criteria: 
gender: All
minimum age: 35 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jacques AMAR, MD PhD
role: Study Director
affiliation: CHU Toulouse
last name: Jacques Moreau, MD
role: Principal Investigator
affiliation: CHU Toulouse
facility: 
country: France
responsible party type: Sponsor
mesh term: Metabolic Diseases