<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/NCT03013296</url>
  </required_header>
  <id_info>
    <org_study_id>UHG-CFD-GIPANTA-4</org_study_id>
    <nct_id>NCT03013296</nct_id>
  </id_info>
  <brief_title>Delinieation of GIP's Effects During a Meal in Humans Using GIP Receptor Antagonisation (GA-4)</brief_title>
  <official_title>Delinieation of GIP's Effects During a Meal in Humans Using GIP Receptor Antagonisation (GA-4)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Gentofte, Copenhagen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Copenhagen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Gentofte, Copenhagen</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Delinieation of GIP's effects during a meal in humans using GIP receptor antagonisation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aim: To evaluate the role of GIPR signalling in postprandial physiology, including lipid,&#xD;
      bone and glucose homeostasis, using a naturally occurring GIP fragment, which antagonises the&#xD;
      GIPR.&#xD;
&#xD;
      Twelve healthy men (age 18-70 years, BMI 19-27 kg/m2) with normal kidney and liver parameters&#xD;
      and haemoglobin levels and no first-degree relatives with type 2 diabetes will be included in&#xD;
      a randomised, double-blinded, placebo-controlled cross-over study. Study consists of four&#xD;
      study days with concomitant infusions of A) GIP-A, B) GLP-1 receptor antagonist&#xD;
      Exendin[9-39], C) GIP-A + Exendin[9-39], or D) saline (placebo).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2016</start_date>
  <completion_date type="Actual">September 2018</completion_date>
  <primary_completion_date type="Actual">July 2017</primary_completion_date>
  <phase>N/A</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>C-peptide levels</measure>
    <time_frame>180 minutes</time_frame>
    <description>Serum C-peptide AUC. Primary outcome changed during the inclusion period (original = insulin levels) due to risk of misinterpretation/diverse hepatic insulin extraction).</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Glucose Metabolism Disorders</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Saline</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GIP-A</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Infusion of GIP-A alone as study tool.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GLP-1 receptor antagonist Exendin[9-39]</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Infusion of GLP-1 receptor antagonist Exendin[9-39] alone as study tool.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GIP-A + Exendin[9-39]</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Infusion of GIP-A + GLP-1 receptor antagonist Exendin[9-39] together as study tools.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>GIP-A</intervention_name>
    <description>GIP-A</description>
    <arm_group_label>GIP-A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>GLP-1 receptor antagonist Exendin[9-39]</intervention_name>
    <description>Exendin[9-39]</description>
    <arm_group_label>GLP-1 receptor antagonist Exendin[9-39]</arm_group_label>
    <other_name>Ex(9-39)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>GIP-A + Exendin[9-39]</intervention_name>
    <description>GIP-A + Exendin[9-39]</description>
    <arm_group_label>GIP-A + Exendin[9-39]</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Normal kidney function, liver function and hemoglobin levels.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medication, Diabetes type 1 or 2, BMI &gt; 27, first degree relatives with Type 2&#xD;
             Diabetes&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fip K Knop, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>UHGentofte, Center for Diabetes Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Center for Diabetes Research</name>
      <address>
        <city>Copenhagen</city>
        <state>Gentofte</state>
        <zip>2900</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>January 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>June 1, 2019</last_update_submitted>
  <last_update_submitted_qc>June 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Gentofte, Copenhagen</investigator_affiliation>
    <investigator_full_name>Lærke Smidt Gasbjerg</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>GIP</keyword>
  <keyword>GIP receptor antagonist</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metabolic Diseases</mesh_term>
    <mesh_term>Glucose Metabolism Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03013296
org study id: UHG-CFD-GIPANTA-4
nct id: NCT03013296
lead sponsor: 
collaborator: 
has dmc: Yes
Delinieation of GIP's effects during a meal in humans using GIP receptor antagonisation.
Aim: To evaluate the role of GIPR signalling in postprandial physiology, including lipid,
      bone and glucose homeostasis, using a naturally occurring GIP fragment, which antagonises the
      GIPR.

      Twelve healthy men (age 18-70 years, BMI 19-27 kg/m2) with normal kidney and liver parameters
      and haemoglobin levels and no first-degree relatives with type 2 diabetes will be included in
      a randomised, double-blinded, placebo-controlled cross-over study. Study consists of four
      study days with concomitant infusions of A) GIP-A, B) GLP-1 receptor antagonist
      Exendin[9-39], C) GIP-A + Exendin[9-39], or D) saline (placebo).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: C-peptide levels
time frame: 180 minutes
description: Serum C-peptide AUC. Primary outcome changed during the inclusion period (original = insulin levels) due to risk of misinterpretation/diverse hepatic insulin extraction).
arm group label: Placebo
arm group type: Placebo Comparator
description: Saline
arm group label: GIP-A
arm group type: Other
description: Infusion of GIP-A alone as study tool.
arm group label: GLP-1 receptor antagonist Exendin[9-39]
arm group type: Other
description: Infusion of GLP-1 receptor antagonist Exendin[9-39] alone as study tool.
arm group label: GIP-A + Exendin[9-39]
arm group type: Other
description: Infusion of GIP-A + GLP-1 receptor antagonist Exendin[9-39] together as study tools.
intervention type: Other
intervention name: GIP-A
description: GIP-A
arm group label: GIP-A
intervention type: Other
intervention name: Placebo
description: Placebo
arm group label: Placebo
intervention type: Other
intervention name: GLP-1 receptor antagonist Exendin[9-39]
description: Exendin[9-39]
arm group label: GLP-1 receptor antagonist Exendin[9-39]
other name: Ex(9-39)
intervention type: Other
intervention name: GIP-A + Exendin[9-39]
description: GIP-A + Exendin[9-39]
arm group label: GIP-A + Exendin[9-39]
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Fip K Knop, MD, PhD
role: Study Director
affiliation: UHGentofte, Center for Diabetes Research
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Gentofte, Copenhagen
investigator full name: Lærke Smidt Gasbjerg
investigator title: MD
mesh term: Metabolic Diseases
mesh term: Glucose Metabolism Disorders
sharing ipd: Undecided