<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/NCT01689051</url>
  </required_header>
  <id_info>
    <org_study_id>1-Sivertsen</org_study_id>
    <nct_id>NCT01689051</nct_id>
  </id_info>
  <brief_title>Vasodilatory and Metabolic Effects of Glucagon-like Peptide-1 in Periphery Circulation in Patients With and Without Type 2 Diabetes Mellitus</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Gentofte, Copenhagen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Danish Heart Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Gentofte, Copenhagen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Diabetes and high blood pressure are risk factors for developing heart disease. An increase&#xD;
      in the number of diabetes patients is expected. This increases the number of patients with&#xD;
      heart disease, and since the vast majority with diabetes die from heart disease, it is&#xD;
      extremely important to investigate how these diseases can be prevented and treated.&#xD;
&#xD;
      Studies in animals have shown that intestinal hormone glucagon-like peptide-1 (GLP-1) can&#xD;
      expand blood vessels, thus lowering blood pressure, but it is not known whether the effects&#xD;
      is found in humans, which we will investigate.&#xD;
&#xD;
      Studies have also shown that GLP-1 lowers blood sugar, but it is unclear whether this is&#xD;
      solely due to increased insulin production, weight loss associated with GLP-1 intake or GLP-1&#xD;
      has an effect on the muscles which increases the uptake of sugar. We investigate whether&#xD;
      GLP-1 enhances the absorption of sugar in the leg.&#xD;
&#xD;
      The investigators also examines whether these effects are greater in people with diabetes&#xD;
      then in healthy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2012</start_date>
  <completion_date type="Actual">April 2013</completion_date>
  <primary_completion_date type="Actual">April 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Femoral artery blood flow</measure>
  </primary_outcome>
  <secondary_outcome>
    <measure>Leg glucose uptake</measure>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Type 2 Diabetes</condition>
  <condition>Blod Pressure</condition>
  <condition>Glucagon-like Peptide-1</condition>
  <condition>Human Physiology</condition>
  <condition>Blood Flow</condition>
  <arm_group>
    <arm_group_label>Healthy subjects</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients with type 2 diabetes</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>human glucagon-like peptide 1 (7-36)amide</intervention_name>
    <arm_group_label>Healthy subjects</arm_group_label>
    <arm_group_label>Patients with type 2 diabetes</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>human glucagon-like peptide 1 (9-36)amide</intervention_name>
    <arm_group_label>Healthy subjects</arm_group_label>
    <arm_group_label>Patients with type 2 diabetes</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
          -  T2DM according to WHO's criteria (only T2DM subjects)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Anemia&#xD;
&#xD;
          -  T1DM&#xD;
&#xD;
          -  Severe liver or renal disease&#xD;
&#xD;
          -  Severe heart disease&#xD;
&#xD;
          -  Atrial fibrillation&#xD;
      </textblock>
    </criteria>
    <gender>Male</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>Jacob C Sivertsen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Gentofte, Copenhagen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gentofte Hospital, Department of Cardiology</name>
      <address>
        <city>Hellerup</city>
        <zip>2900</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>January 2014</verification_date>
  <study_first_submitted>September 17, 2012</study_first_submitted>
  <study_first_submitted_qc>September 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 20, 2012</study_first_posted>
  <last_update_submitted>January 30, 2014</last_update_submitted>
  <last_update_submitted_qc>January 30, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 31, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Gentofte, Copenhagen</investigator_affiliation>
    <investigator_full_name>Jacob Christian Sivertsen</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Type 2 diabetes</keyword>
  <keyword>Blod pressure</keyword>
  <keyword>Glucagon-like peptide-1</keyword>
  <keyword>Human physiology</keyword>
  <keyword>Blood flow</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glucagon</mesh_term>
    <mesh_term>Glucagon-Like Peptide 1</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/NCT01689051
org study id: 1-Sivertsen
nct id: NCT01689051
lead sponsor: 
collaborator: 
has dmc: No
Diabetes and high blood pressure are risk factors for developing heart disease. An increase
      in the number of diabetes patients is expected. This increases the number of patients with
      heart disease, and since the vast majority with diabetes die from heart disease, it is
      extremely important to investigate how these diseases can be prevented and treated.

      Studies in animals have shown that intestinal hormone glucagon-like peptide-1 (GLP-1) can
      expand blood vessels, thus lowering blood pressure, but it is not known whether the effects
      is found in humans, which we will investigate.

      Studies have also shown that GLP-1 lowers blood sugar, but it is unclear whether this is
      solely due to increased insulin production, weight loss associated with GLP-1 intake or GLP-1
      has an effect on the muscles which increases the uptake of sugar. We investigate whether
      GLP-1 enhances the absorption of sugar in the leg.

      The investigators also examines whether these effects are greater in people with diabetes
      then in healthy.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Femoral artery blood flow
measure: Leg glucose uptake
arm group label: Healthy subjects
arm group type: Active Comparator
arm group label: Patients with type 2 diabetes
arm group type: Active Comparator
intervention type: Other
intervention name: human glucagon-like peptide 1 (7-36)amide
arm group label: Healthy subjects
arm group label: Patients with type 2 diabetes
intervention type: Other
intervention name: human glucagon-like peptide 1 (9-36)amide
arm group label: Healthy subjects
arm group label: Patients with type 2 diabetes
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jacob C Sivertsen, MD
role: Principal Investigator
affiliation: University Hospital, Gentofte, Copenhagen
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Gentofte, Copenhagen
investigator full name: Jacob Christian Sivertsen
investigator title: MD
mesh term: Diabetes Mellitus, Type 2
mesh term: Glucagon
mesh term: Glucagon-Like Peptide 1