<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/NCT02235584</url>
  </required_header>
  <id_info>
    <org_study_id>H-D-2009-070</org_study_id>
    <nct_id>NCT02235584</nct_id>
  </id_info>
  <brief_title>Insulinotropic Effect of GLP-1 and GIP After Dexamethasone</brief_title>
  <official_title>Loss of Insulinotropic Properties of Glucagon-like Peptide-1 (GLP-1) and Glucose-dependent Insulinotropic Peptide (GIP) After Glucocorticoid Induced Insulin Resistance</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hvidovre University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hvidovre University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study we examine whether inducing insulin resistance by dexamethasone in healthy&#xD;
      volunteers will lead to a decreased insulinotropic effect of the hormones GLP-1 and GIP.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study we are going to examine the insulinotropic properties of GLP-1 and GIP before&#xD;
      and after the development of insulin resistance and/or glucose intolerance.The insulinotropic&#xD;
      properties of GLP-1 and GIP are greatly reduced in type 2 diabetes.&#xD;
&#xD;
      Since the development of type 2 diabetes is preceded by insulin resistance and glucose&#xD;
      intolerance we wanted to examine the insulinotropic properties of GLP-1 and GIP in the early&#xD;
      stages of type 2 diabetes.&#xD;
&#xD;
      To do this, we want to induce insulin resistance and/or glucose intolerance. This is achieved&#xD;
      by 5 days of treatment with dexamethasone.&#xD;
&#xD;
      Subjects are studied on 4 different days in randomized order, with an oral glucose tolerance&#xD;
      test (OGTT) and glucose clamps + infusions of GLP-1, GIP and NaCl before and immediately&#xD;
      after 5 days treatment with dexamethasone, 2mg bid. On day 1, 2 and 3 after the 5 days of&#xD;
      dexamethasone, 2mg dexamethasone was given in the afternoon after the tests to ensure&#xD;
      unchanged insulin resistance&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2009</start_date>
  <primary_completion_date type="Actual">June 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The potentiating effects of GLP-1 on second phase insulin response when clamped at at bloodsugar of 7 mmol/l</measure>
    <time_frame>1-3 days after dexamethasone treatment</time_frame>
    <description>After dexamethasone treatment subjects are tested with infusion of GLP-1 during a clamped blood-sugar of 7mmol/l. Their increase in the second phase insulin response is the primary endpoint.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>First phase insulin response to GLP-1 infusion at 7mmol/l</measure>
    <time_frame>1-3 days after dexamethasone</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>First phase insulin response to GIP infusion at 7mmol/l</measure>
    <time_frame>1-3 days after dexamethasone</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Second phase insulin response to GIP infusion at 7mmol/l</measure>
    <time_frame>1-3 days after dexamethasone treatment</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Total insulin response to arginine infusion</measure>
    <time_frame>1-3 days after dexamethasone</time_frame>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Type 2 Diabetes</condition>
  <arm_group>
    <arm_group_label>Dexamethasone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This is a before-after study. All subjects are administered dexamethasone 2mg BID for 5 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <description>Dexamethasone are given dexamethasone tablets of 2mg twice daily.</description>
    <arm_group_label>Dexamethasone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Caucasians above 20 and below 45 years of age&#xD;
&#xD;
          -  Normal glucose tolerance as assessed by the WHO criteria&#xD;
&#xD;
          -  First degree relative and at least 1 second degree relative with type 2 diabetes&#xD;
&#xD;
          -  Normal haemoglobin&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Liver disease (ALAT/ASAT &gt; 2 times normal value)&#xD;
&#xD;
          -  Kidney disease (S-creatinin &gt; 130uM and/or albuminuria)&#xD;
&#xD;
          -  Heart disease (NYHA II, III or IV)&#xD;
&#xD;
          -  Treatment with medicine that cannot be paused&#xD;
&#xD;
          -  Pregnancy of breast feeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thure Krarup, dr. med.</last_name>
    <role>Study Director</role>
    <affiliation>Bispebjerg Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bispebjerg University Hospital</name>
      <address>
        <city>Copenhagen NV</city>
        <zip>2400</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 7, 2014</study_first_submitted>
  <study_first_submitted_qc>September 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <last_update_submitted>September 7, 2014</last_update_submitted>
  <last_update_submitted_qc>September 7, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 10, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hvidovre University Hospital</investigator_affiliation>
    <investigator_full_name>Carsten Dirksen</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Incretin hormones</keyword>
  <keyword>GLP-1</keyword>
  <keyword>GIP</keyword>
  <keyword>Dexamethasone</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</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/NCT02235584
org study id: H-D-2009-070
nct id: NCT02235584
lead sponsor: 
has dmc: No
In this study we examine whether inducing insulin resistance by dexamethasone in healthy
      volunteers will lead to a decreased insulinotropic effect of the hormones GLP-1 and GIP.
In this study we are going to examine the insulinotropic properties of GLP-1 and GIP before
      and after the development of insulin resistance and/or glucose intolerance.The insulinotropic
      properties of GLP-1 and GIP are greatly reduced in type 2 diabetes.

      Since the development of type 2 diabetes is preceded by insulin resistance and glucose
      intolerance we wanted to examine the insulinotropic properties of GLP-1 and GIP in the early
      stages of type 2 diabetes.

      To do this, we want to induce insulin resistance and/or glucose intolerance. This is achieved
      by 5 days of treatment with dexamethasone.

      Subjects are studied on 4 different days in randomized order, with an oral glucose tolerance
      test (OGTT) and glucose clamps + infusions of GLP-1, GIP and NaCl before and immediately
      after 5 days treatment with dexamethasone, 2mg bid. On day 1, 2 and 3 after the 5 days of
      dexamethasone, 2mg dexamethasone was given in the afternoon after the tests to ensure
      unchanged insulin resistance
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: The potentiating effects of GLP-1 on second phase insulin response when clamped at at bloodsugar of 7 mmol/l
time frame: 1-3 days after dexamethasone treatment
description: After dexamethasone treatment subjects are tested with infusion of GLP-1 during a clamped blood-sugar of 7mmol/l. Their increase in the second phase insulin response is the primary endpoint.
measure: First phase insulin response to GLP-1 infusion at 7mmol/l
time frame: 1-3 days after dexamethasone
measure: First phase insulin response to GIP infusion at 7mmol/l
time frame: 1-3 days after dexamethasone
measure: Second phase insulin response to GIP infusion at 7mmol/l
time frame: 1-3 days after dexamethasone treatment
measure: Total insulin response to arginine infusion
time frame: 1-3 days after dexamethasone
arm group label: Dexamethasone
arm group type: Experimental
description: This is a before-after study. All subjects are administered dexamethasone 2mg BID for 5 days.
intervention type: Drug
intervention name: Dexamethasone
description: Dexamethasone are given dexamethasone tablets of 2mg twice daily.
arm group label: Dexamethasone
criteria: 
gender: All
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Thure Krarup, dr. med.
role: Study Director
affiliation: Bispebjerg Hospital
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Hvidovre University Hospital
investigator full name: Carsten Dirksen
investigator title: MD
mesh term: Dexamethasone