<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/NCT03003793</url>
  </required_header>
  <id_info>
    <org_study_id>H-15010198</org_study_id>
    <nct_id>NCT03003793</nct_id>
  </id_info>
  <brief_title>Insulin Sensitivity in Patients With Atopic Dermatitis</brief_title>
  <acronym>AD-IF</acronym>
  <official_title>Insulin Sensitivity in Patients With Atopic Dermatitis</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>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The incidence of atopic dermatitis and type 2 diabetes, respectively, has increased over many&#xD;
      years. Novel research shows an association between the two conditions. While this&#xD;
      relationship at least in theory can be explained by lifestyle factors, there is reason to&#xD;
      believe that other pathophysiological mechanisms are involved. Hence, our hypothesis is that&#xD;
      patients with atopic dermatitis are insulin resistant due to their chronic inflammatory&#xD;
      state. Insulin resistance might play an unknown part in the increased frequency of type 2&#xD;
      diabetes among patients with atopic dermatitis. In the present project, the investigators aim&#xD;
      to measure insulin sensitivity by means of the 'golden standard' hyperinsulinaemic&#xD;
      euglycaemic clamp in patients suffering from atopic dermatitis compared to a healthy control&#xD;
      group (matched case-control study). The project is a close collaboration between The&#xD;
      Department of Dermatology and Allergy and Center for Diabetes Research at Gentofte Hospital.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2015</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">September 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Insulin Sensitivity Difference Between Patients With Atopic Dermatitis and Controls</measure>
    <time_frame>Baseline, plasma glucose every 5 minutes, insulin/C-peptide, glucagon every 10-15 minutes throughout a 3 hour hyperinsulinaemic euglycaemic clamp</time_frame>
    <description>The outcome is determined by measuring the glucose necessary to maintain euglycaemia during increased insulin levels generated by continuous insulin infusion (measured as the M-value: the rate of glucose infused is equal to the rate of whole-body glucose disposal or metabolizable glucose (M) and reflects the amount of exogenous glucose necessary to fully compensate for the hyperinsulinemia)</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">32</enrollment>
  <condition>Atopic Dermatitis/Eczema</condition>
  <condition>Type 2 Diabetes</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>Healthy control subjects</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Atopic dermatitis/eczema group</arm_group_label>
    <description>Patients with atopic dermatitis</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Hyperinsulinemic euglycemic clamp</intervention_name>
    <description>Hyperinsulinemic euglycemic clamp to detect insulin sensitivity</description>
    <arm_group_label>Atopic dermatitis/eczema group</arm_group_label>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Whole blood.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with atopic dermatitis are recruited from Department of Dermatology and&#xD;
        Allergology at Gentofte Hospital.&#xD;
&#xD;
        Control subjects are recruited from the Danish recruitment site &quot;www.forsoegsperson.dk&quot;.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Moderate to severe atopic dermatitis for at least 5 years&#xD;
&#xD;
          -  BMI &lt; 30 kg/m2&#xD;
&#xD;
          -  HbA1c &lt; 42 mmol/mol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  Prediabetes&#xD;
&#xD;
          -  First-degree relatives with diabetes&#xD;
&#xD;
          -  Chronic inflammatory diseases other than atopic dermatitis and asthma&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Breast-feeding&#xD;
&#xD;
          -  Daily intake of medications that are known to influence the glucose metabolism are not&#xD;
             allowed one month before the study (e.g. asthma medicines and hormonal contraception).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Filip K Knop, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University Hospital, Gentofte</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jacob P Thyssen, MD,PhD,DMSc</last_name>
    <role>Study Director</role>
    <affiliation>University Hospital, Gentofte</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Center for Diabetes Research, Gentofte Hospital, University of Copenhagen</name>
      <address>
        <city>Hellerup</city>
        <zip>2900</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>March 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 27, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 28, 2016</study_first_posted>
  <results_first_submitted>June 19, 2019</results_first_submitted>
  <results_first_submitted_qc>September 25, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">October 18, 2019</results_first_posted>
  <last_update_submitted>September 25, 2019</last_update_submitted>
  <last_update_submitted_qc>September 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 18, 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>Filip Krag Knop</investigator_full_name>
    <investigator_title>MD PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dermatitis, Atopic</mesh_term>
    <mesh_term>Dermatitis</mesh_term>
    <mesh_term>Eczema</mesh_term>
    <mesh_term>Insulin Resistance</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Control Group</title>
          <description>Healthy control subjects Hyperinsulinemic euglycemic clamp</description>
        </group>
        <group group_id="P2">
          <title>Atopic Dermatitis/Eczema Group</title>
          <description>Patients with atopic dermatitis Hyperinsulinemic euglycemic clamp</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Control Group</title>
          <description>Healthy control subjects Hyperinsulinemic euglycemic clamp</description>
        </group>
        <group group_id="B2">
          <title>Atopic Dermatitis/Eczema Group</title>
          <description>Patients with atopic dermatitis Hyperinsulinemic euglycemic clamp</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="16"/>
            <count group_id="B2" value="16"/>
            <count group_id="B3" value="32"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33" spread="3"/>
                    <measurement group_id="B2" value="33" spread="3"/>
                    <measurement group_id="B3" value="33" spread="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Denmark</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Atopic dermatitis duration</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="NA" spread="NA">No atopic dermaitits in this group</measurement>
                    <measurement group_id="B2" value="28" spread="3"/>
                    <measurement group_id="B3" value="NA" spread="NA">Only atopic dermaitits in one of the groups.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body master index</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24.4" spread="1"/>
                    <measurement group_id="B2" value="24.5" spread="1"/>
                    <measurement group_id="B3" value="24.5" spread="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Insulin Sensitivity Difference Between Patients With Atopic Dermatitis and Controls</title>
        <description>The outcome is determined by measuring the glucose necessary to maintain euglycaemia during increased insulin levels generated by continuous insulin infusion (measured as the M-value: the rate of glucose infused is equal to the rate of whole-body glucose disposal or metabolizable glucose (M) and reflects the amount of exogenous glucose necessary to fully compensate for the hyperinsulinemia)</description>
        <time_frame>Baseline, plasma glucose every 5 minutes, insulin/C-peptide, glucagon every 10-15 minutes throughout a 3 hour hyperinsulinaemic euglycaemic clamp</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control Group</title>
            <description>Healthy control subjects Hyperinsulinemic euglycemic clamp</description>
          </group>
          <group group_id="O2">
            <title>Atopic Dermatitis/Eczema Group</title>
            <description>Patients with atopic dermatitis Hyperinsulinemic euglycemic clamp</description>
          </group>
        </group_list>
        <measure>
          <title>Insulin Sensitivity Difference Between Patients With Atopic Dermatitis and Controls</title>
          <description>The outcome is determined by measuring the glucose necessary to maintain euglycaemia during increased insulin levels generated by continuous insulin infusion (measured as the M-value: the rate of glucose infused is equal to the rate of whole-body glucose disposal or metabolizable glucose (M) and reflects the amount of exogenous glucose necessary to fully compensate for the hyperinsulinemia)</description>
          <units>mg glucose/kg body mass/minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.8" spread="0.8"/>
                    <measurement group_id="O2" value="9.2" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Control Group</title>
          <description>Healthy control subjects Hyperinsulinemic euglycemic clamp</description>
        </group>
        <group group_id="E2">
          <title>Atopic Dermatitis/Eczema Group</title>
          <description>Patients with atopic dermatitis Hyperinsulinemic euglycemic clamp</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Lise Gether, MD</name_or_title>
      <organization>Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen</organization>
      <email>lise.gether.01@regionh.dk</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03003793
org study id: H-15010198
nct id: NCT03003793
lead sponsor: 
has dmc: No
The incidence of atopic dermatitis and type 2 diabetes, respectively, has increased over many
      years. Novel research shows an association between the two conditions. While this
      relationship at least in theory can be explained by lifestyle factors, there is reason to
      believe that other pathophysiological mechanisms are involved. Hence, our hypothesis is that
      patients with atopic dermatitis are insulin resistant due to their chronic inflammatory
      state. Insulin resistance might play an unknown part in the increased frequency of type 2
      diabetes among patients with atopic dermatitis. In the present project, the investigators aim
      to measure insulin sensitivity by means of the 'golden standard' hyperinsulinaemic
      euglycaemic clamp in patients suffering from atopic dermatitis compared to a healthy control
      group (matched case-control study). The project is a close collaboration between The
      Department of Dermatology and Allergy and Center for Diabetes Research at Gentofte Hospital.
observational model: Case-Control
time perspective: Prospective
measure: Insulin Sensitivity Difference Between Patients With Atopic Dermatitis and Controls
time frame: Baseline, plasma glucose every 5 minutes, insulin/C-peptide, glucagon every 10-15 minutes throughout a 3 hour hyperinsulinaemic euglycaemic clamp
description: The outcome is determined by measuring the glucose necessary to maintain euglycaemia during increased insulin levels generated by continuous insulin infusion (measured as the M-value: the rate of glucose infused is equal to the rate of whole-body glucose disposal or metabolizable glucose (M) and reflects the amount of exogenous glucose necessary to fully compensate for the hyperinsulinemia)
arm group label: Control group
description: Healthy control subjects
arm group label: Atopic dermatitis/eczema group
description: Patients with atopic dermatitis
intervention type: Diagnostic Test
intervention name: Hyperinsulinemic euglycemic clamp
description: Hyperinsulinemic euglycemic clamp to detect insulin sensitivity
arm group label: Atopic dermatitis/eczema group
arm group label: Control group
Whole blood.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Filip K Knop, MD, PhD
role: Study Director
affiliation: University Hospital, Gentofte
last name: Jacob P Thyssen, MD,PhD,DMSc
role: Study Director
affiliation: University Hospital, Gentofte
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Gentofte, Copenhagen
investigator full name: Filip Krag Knop
investigator title: MD PhD
mesh term: Dermatitis, Atopic
mesh term: Dermatitis
mesh term: Eczema
mesh term: Insulin Resistance
sharing ipd: Undecided
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 