<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/NCT02201550</url>
  </required_header>
  <id_info>
    <org_study_id>H-2-2012-148-KLB</org_study_id>
    <nct_id>NCT02201550</nct_id>
  </id_info>
  <brief_title>Study of Immune Cells in Obese Patients With Type 2 Diabetes Mellitus Treated With Liraglutide</brief_title>
  <official_title>Regulation of Immune Cells in Obese Patients With Type 2 Diabetes Mellitus Treated With Liraglutide (Victoza)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hvidovre University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Zealand Pharma</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Hvidovre University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the effect of exogenous glucagon-like peptide-1 on&#xD;
      the immune system i.e on the regulation of immune cells important in diseases such as obesity&#xD;
      and diabetes.&#xD;
&#xD;
      The hypotheses are:&#xD;
&#xD;
        -  Glucagon-like peptide-1 has an immunological effect observed by studying immune cells in&#xD;
           the blood&#xD;
&#xD;
        -  Treatment with glucagon-like peptide-1 increases the number of immune cells in the blood&#xD;
&#xD;
        -  Treatment with glucagon-like peptide-1 leads to a more anti-inflammatory cytokine&#xD;
           profile in the blood&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2013</start_date>
  <completion_date type="Actual">April 2014</completion_date>
  <primary_completion_date type="Actual">April 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in number of specific immune cells in blood detected by flow cytometry</measure>
    <time_frame>Before and 12 weeks after initiation of liraglutide treatment</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">9</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Liraglutide</arm_group_label>
    <description>Patients with type 2 diabetes undertaking treatment with liraglutide</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with type 2 diabetes undertaking treatment with liraglutide&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Type 2 diabetes&#xD;
&#xD;
          -  BMI &gt; 27 kg/m2&#xD;
&#xD;
          -  Planed start of treatment with liraglutide&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Infection or active inflammatory disorder&#xD;
&#xD;
          -  Immunomodulating treatment (i.e nonsteroidal antiinflammatory drugs, glucocorticoids)&#xD;
&#xD;
          -  Smoking&#xD;
&#xD;
          -  Alcohol consumption &gt; 14 beverages/week&#xD;
&#xD;
          -  Former bariatric surgery&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carsten Dirksen, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hvidovre University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sten Madsbad, MD, DMSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hvidovre University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hvidovre University Hospital</name>
      <address>
        <city>Hvidovre</city>
        <zip>2650</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 24, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 28, 2014</study_first_posted>
  <last_update_submitted>July 24, 2014</last_update_submitted>
  <last_update_submitted_qc>July 24, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 28, 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, PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</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/NCT02201550
org study id: H-2-2012-148-KLB
nct id: NCT02201550
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to determine the effect of exogenous glucagon-like peptide-1 on
      the immune system i.e on the regulation of immune cells important in diseases such as obesity
      and diabetes.

      The hypotheses are:

        -  Glucagon-like peptide-1 has an immunological effect observed by studying immune cells in
           the blood

        -  Treatment with glucagon-like peptide-1 increases the number of immune cells in the blood

        -  Treatment with glucagon-like peptide-1 leads to a more anti-inflammatory cytokine
           profile in the blood
observational model: Case-Only
time perspective: Prospective
measure: Change in number of specific immune cells in blood detected by flow cytometry
time frame: Before and 12 weeks after initiation of liraglutide treatment
arm group label: Liraglutide
description: Patients with type 2 diabetes undertaking treatment with liraglutide
Blood samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Carsten Dirksen, MD, PhD
role: Principal Investigator
affiliation: Hvidovre University Hospital
last name: Sten Madsbad, MD, DMSc
role: Principal Investigator
affiliation: Hvidovre University Hospital
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Hvidovre University Hospital
investigator full name: Carsten Dirksen
investigator title: MD, PhD
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2