<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/NCT03009916</url>
  </required_header>
  <id_info>
    <org_study_id>H-15004394</org_study_id>
    <nct_id>NCT03009916</nct_id>
  </id_info>
  <brief_title>Bileacid Malabsorption and GLP-1 Secretion</brief_title>
  <official_title>Bileacid Malabsorption and GLP-1 Secretion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Gentofte, Copenhagen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Gentofte, Copenhagen</source>
  <brief_summary>
    <textblock>
      The aim of this study is to examine the influence of BAM on postprandial GLP--1 secretion and&#xD;
      glucose homeostasis, both with and without bile acid sequestration.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2016</start_date>
  <completion_date type="Actual">August 4, 2017</completion_date>
  <primary_completion_date type="Actual">August 3, 2017</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>GLP-1</measure>
    <time_frame>240 min</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Bileacid Malabsorption</condition>
  <arm_group>
    <arm_group_label>Healthy controls</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Healthy controls found according to the protocol</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients with BAM</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients with bile acid malabsorption found according to the protocol</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>&quot;cholestagel®&quot; (Colesevelam)</intervention_name>
    <description>3750mg</description>
    <arm_group_label>Healthy controls</arm_group_label>
    <arm_group_label>Patients with BAM</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebos</intervention_name>
    <description>3750mg</description>
    <arm_group_label>Healthy controls</arm_group_label>
    <arm_group_label>Patients with BAM</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Northern European origin&#xD;
&#xD;
          -  Normal haemoglobin&#xD;
&#xD;
          -  Age above 18 years and below 70 years&#xD;
&#xD;
          -  Informed and written consent&#xD;
&#xD;
          -  BMI &gt; 23 kg/m2 and &lt; 35 kg/m2&#xD;
&#xD;
          -  Normal fasting plasma glucose (FPG) &lt; 6.5 mM) and glycated haemoglobin (HbA1c) &lt; 48&#xD;
             mmol/mol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Liver disease (alanine aminotransferase (ALAT) and/or serum aspartate aminotransferase&#xD;
             (ASAT) &gt;2 times normal values) or history of hepatobiliary disorder&#xD;
&#xD;
          -  Gastrointestinal disease (except BAM), previous intestinal resection, cholecystectomy&#xD;
             or any major intra-abdominal surgery&#xD;
&#xD;
          -  First-degree relatives with diabetes&#xD;
&#xD;
          -  Nephropathy (serum creatinine &gt;150 µM and/or albuminuria&#xD;
&#xD;
          -  Treatment with medicine that cannot be paused for 12 hours&#xD;
&#xD;
          -  Hypothyroidism or hyperthyroidism&#xD;
&#xD;
          -  Treatment with oral anticoagulants&#xD;
&#xD;
          -  Active or recent malignant disease&#xD;
&#xD;
          -  Any treatment or condition requiring acute or sub-acute medical or surgical&#xD;
             intervention&#xD;
&#xD;
          -  Lack of effective birth control in premenopausal women&#xD;
&#xD;
          -  Any condition considered incompatible with participation by the investigators&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Center for Diabetes Research, Gentofte Hospital</name>
      <address>
        <city>Hellerup</city>
        <zip>2900</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>December 21, 2016</study_first_submitted>
  <study_first_submitted_qc>January 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>August 4, 2017</last_update_submitted>
  <last_update_submitted_qc>August 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Gentofte, Copenhagen</investigator_affiliation>
    <investigator_full_name>Filip Krag Knop</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malabsorption Syndromes</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colesevelam Hydrochloride</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/NCT03009916
org study id: H-15004394
nct id: NCT03009916
lead sponsor: 
The aim of this study is to examine the influence of BAM on postprandial GLP--1 secretion and
      glucose homeostasis, both with and without bile acid sequestration.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: GLP-1
time frame: 240 min
arm group label: Healthy controls
arm group type: Other
description: Healthy controls found according to the protocol
arm group label: Patients with BAM
arm group type: Other
description: Patients with bile acid malabsorption found according to the protocol
intervention type: Drug
intervention name: "cholestagel®" (Colesevelam)
description: 3750mg
arm group label: Healthy controls
arm group label: Patients with BAM
intervention type: Drug
intervention name: Placebos
description: 3750mg
arm group label: Healthy controls
arm group label: Patients with BAM
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Gentofte, Copenhagen
investigator full name: Filip Krag Knop
investigator title: Professor
mesh term: Malabsorption Syndromes
mesh term: Colesevelam Hydrochloride