<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/NCT03017703</url>
  </required_header>
  <id_info>
    <org_study_id>H- 15007940</org_study_id>
    <nct_id>NCT03017703</nct_id>
  </id_info>
  <brief_title>The Role of Aldosterone in Circulatory Disorders Within Type 2 Diabetes</brief_title>
  <official_title>The Role of Aldosterone in Diabetes Related Vascular Disease, a New Therapeutic Target?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southern Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Southern Denmark</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The importance of Aldosterone for endothelial function and Insulin resistance observed within&#xD;
      patients with type 2 diabetes&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2016</start_date>
  <completion_date type="Actual">December 15, 2019</completion_date>
  <primary_completion_date type="Actual">October 1, 2019</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>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Vascular function</measure>
    <time_frame>8 weeks</time_frame>
    <description>Femoral arterial blood flow in response to femoral arterially infused ACh</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Insulin sensitivity measured by a insulin clamp</measure>
    <time_frame>8 weeks</time_frame>
    <description>Glucose infusion rate during euglycaemic-hyperinsulinaemic clamp</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Vascular function</measure>
    <time_frame>8 weeks</time_frame>
    <description>Microperfusion performed on blood vessels in vitro obtained from muscle biopsies</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Endothelial Dysfunction</condition>
  <condition>Insulin Resistance</condition>
  <arm_group>
    <arm_group_label>Type 2 Diabetes</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>8 weeks of treatment with Aldosterone blocker Eplerenone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>8 weeks of treatment with Aldosterone blocker Eplerenone</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Eplerenone</intervention_name>
    <arm_group_label>Healthy</arm_group_label>
    <arm_group_label>Type 2 Diabetes</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed diabetic &lt; 5 Yrs.&#xD;
&#xD;
          -  BMI &lt; 32 kg/m2&#xD;
&#xD;
          -  Non-smoking&#xD;
&#xD;
          -  Blood pressure &lt; 140/90 mmHg (treatment with maximum of two antihypertensive drugs)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Insulin treatment&#xD;
&#xD;
          -  Hypertension (&gt;140/90 mmHg)&#xD;
&#xD;
          -  Sequelae to diabetes&#xD;
&#xD;
          -  Smoking&#xD;
&#xD;
          -  Known chronic diseases&#xD;
&#xD;
          -  Pregnancy or birth within 3 month&#xD;
&#xD;
          -  Alcohol misuse&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stefan P Mortensen, DMSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Southern Denmark</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cardiovascular and Renal Research</name>
      <address>
        <city>Odense</city>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>January 2, 2017</study_first_submitted>
  <study_first_submitted_qc>January 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>May 28, 2021</last_update_submitted>
  <last_update_submitted_qc>May 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Southern Denmark</investigator_affiliation>
    <investigator_full_name>Stefan Mortensen</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Endothelial dysfunction</keyword>
  <keyword>Insulin resistance</keyword>
  <keyword>Type 2 diabetes</keyword>
  <keyword>Mineralocorticoid blocker</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin Resistance</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Eplerenone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03017703
org study id: H- 15007940
nct id: NCT03017703
lead sponsor: 
has dmc: Yes
The importance of Aldosterone for endothelial function and Insulin resistance observed within
      patients with type 2 diabetes
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Vascular function
time frame: 8 weeks
description: Femoral arterial blood flow in response to femoral arterially infused ACh
measure: Insulin sensitivity measured by a insulin clamp
time frame: 8 weeks
description: Glucose infusion rate during euglycaemic-hyperinsulinaemic clamp
measure: Vascular function
time frame: 8 weeks
description: Microperfusion performed on blood vessels in vitro obtained from muscle biopsies
arm group label: Type 2 Diabetes
arm group type: Experimental
description: 8 weeks of treatment with Aldosterone blocker Eplerenone
arm group label: Healthy
arm group type: Experimental
description: 8 weeks of treatment with Aldosterone blocker Eplerenone
intervention type: Drug
intervention name: Eplerenone
arm group label: Healthy
arm group label: Type 2 Diabetes
criteria: 
gender: All
minimum age: 40 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Stefan P Mortensen, DMSc
role: Principal Investigator
affiliation: University of Southern Denmark
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: University of Southern Denmark
investigator full name: Stefan Mortensen
investigator title: Associate Professor
mesh term: Insulin Resistance
mesh term: Eplerenone
sharing ipd: No