<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/NCT03775902</url>
  </required_header>
  <id_info>
    <org_study_id>NAK-KATP</org_study_id>
    <nct_id>NCT03775902</nct_id>
  </id_info>
  <brief_title>Regulation of KATP Channels and Na+/K+ ATPase in Relation to Fatigue Development</brief_title>
  <official_title>Regulation of KATP Channels and Na+/K+ ATPase in Relation to Fatigue Development in Healthy and Insulin Resistant Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Copenhagen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Copenhagen</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate the role of ATP sensitive K+ potassium channels and the Na+/K+ pump in the&#xD;
      development of fatigue in healthy and in insulin resistant subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 19, 2018</start_date>
  <completion_date type="Actual">January 1, 2020</completion_date>
  <primary_completion_date type="Actual">January 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Extracellular potassium concentration meassured with microdialysis</measure>
    <time_frame>Changes in potassium handling from the placebo experimental day compared to the experimental days with Nicorandil ingestion with 14 days between each experimental day. Timeframe pr. subject approx. 6 weeks</time_frame>
    <description>Interstitial potassium</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Performance (time to exhaustion) during knee extensor exercise</measure>
    <time_frame>Changes in performance during the placebo experimental day compared to the experimental days with Nicorandil ingestion with 14 days between each experimental day. Timeframe pr. subject approx. 6 weeks.</time_frame>
    <description>Muscle exercise tolerance</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Insulin Resistance</condition>
  <arm_group>
    <arm_group_label>Healthy subjects</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Two experimental day where the effect of Nicorandil (20mg) or placebo will asses the function of the ATP sensitive potassium pumps role in the development of fatigue.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Insulin resistant</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Two experimental day where the effect of Nicorandil (20mg) or placebo will asses the function of the ATP sensitive potassium pumps role in the development of fatigue.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>placebo tablet</description>
    <arm_group_label>Healthy subjects</arm_group_label>
    <arm_group_label>Insulin resistant</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nicorandil</intervention_name>
    <description>20 mg nicorandil (Ikorel, Sanofi Winthrop Industrie; NIC)</description>
    <arm_group_label>Healthy subjects</arm_group_label>
    <arm_group_label>Insulin resistant</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Non smokers&#xD;
&#xD;
          -  HbA1c &lt;38 mmol/mol (&lt;5.7%), HOMA-IR &gt; 1.7 (insulin resistant)&#xD;
&#xD;
          -  VO2max &lt;40 ml/kg/min (insulin resistant), 45-55 ml/kg/m2 (healthy)&#xD;
&#xD;
          -  BMI &gt;26 kg/m2 (insulin resistant), 19-26 kg/m2 (healthy)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of antidiabetic medication or any other medication deemed to interfere with study&#xD;
             outcomes&#xD;
&#xD;
          -  Allergy towards Nicorandil&#xD;
&#xD;
          -  Chronic disease other than type 2 diabetes deemed to interfere with study outcomes&#xD;
&#xD;
          -  Excessive alcohol consumption (&gt;14 units/week)&#xD;
&#xD;
          -  Abnormal ECG&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Copenhagen</name>
      <address>
        <city>Copenhagen</city>
        <state>Danmark</state>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>December 4, 2018</study_first_submitted>
  <study_first_submitted_qc>December 13, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 14, 2018</study_first_posted>
  <last_update_submitted>July 4, 2023</last_update_submitted>
  <last_update_submitted_qc>July 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Copenhagen</investigator_affiliation>
    <investigator_full_name>Morten Hostrup, PhD</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>skeletal muscle</keyword>
  <keyword>muscle fatigue</keyword>
  <keyword>ion handling</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin Resistance</mesh_term>
    <mesh_term>Fatigue</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nicorandil</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/NCT03775902
org study id: NAK-KATP
nct id: NCT03775902
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To investigate the role of ATP sensitive K+ potassium channels and the Na+/K+ pump in the
      development of fatigue in healthy and in insulin resistant subjects.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Basic Science
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Extracellular potassium concentration meassured with microdialysis
time frame: Changes in potassium handling from the placebo experimental day compared to the experimental days with Nicorandil ingestion with 14 days between each experimental day. Timeframe pr. subject approx. 6 weeks
description: Interstitial potassium
measure: Performance (time to exhaustion) during knee extensor exercise
time frame: Changes in performance during the placebo experimental day compared to the experimental days with Nicorandil ingestion with 14 days between each experimental day. Timeframe pr. subject approx. 6 weeks.
description: Muscle exercise tolerance
arm group label: Healthy subjects
arm group type: Experimental
description: Two experimental day where the effect of Nicorandil (20mg) or placebo will asses the function of the ATP sensitive potassium pumps role in the development of fatigue.
arm group label: Insulin resistant
arm group type: Experimental
description: Two experimental day where the effect of Nicorandil (20mg) or placebo will asses the function of the ATP sensitive potassium pumps role in the development of fatigue.
intervention type: Drug
intervention name: Placebo
description: placebo tablet
arm group label: Healthy subjects
arm group label: Insulin resistant
intervention type: Drug
intervention name: Nicorandil
description: 20 mg nicorandil (Ikorel, Sanofi Winthrop Industrie; NIC)
arm group label: Healthy subjects
arm group label: Insulin resistant
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: University of Copenhagen
investigator full name: Morten Hostrup, PhD
investigator title: Associate Professor
mesh term: Insulin Resistance
mesh term: Fatigue
mesh term: Nicorandil