<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/NCT04450134</url>
  </required_header>
  <id_info>
    <org_study_id>HIST-TRAINING</org_study_id>
    <nct_id>NCT04450134</nct_id>
  </id_info>
  <brief_title>Histamine H1/H2 Receptors and Training Adaptations</brief_title>
  <official_title>Role of Histamine H1/H2 Receptors in the Health- and Performance-promoting Adaptations to High-intensity Interval Training</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wim Derave</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Research Foundation Flanders</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Copenhagen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Ghent</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Exercise training is beneficial for both health and performance. Histamine has been shown to&#xD;
      be involved in the acute exercise response. The current study addresses the role of histamine&#xD;
      H1/H2 receptor signaling in the chronic training-induced adaptations. Results from this study&#xD;
      will yield more insights into the molecular mechanisms of adaptations to exercise training.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2, 2019</start_date>
  <completion_date type="Actual">April 14, 2021</completion_date>
  <primary_completion_date type="Actual">December 18, 2019</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>Parallel Assignment</intervention_model>
    <intervention_model_description>Placebo + exercise vs histamine blockade + exercise</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Double-blind for researchers and participants</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in cardiorespiratory fitness</measure>
    <time_frame>Before, after 3 weeks and after 6 weeks of exercise training</time_frame>
    <description>Change in maximal oxygen uptake during incremental cycling test on cycle ergometer during the 6 week training period</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in peak aerobic power output</measure>
    <time_frame>Before, after 3 weeks and after 6 weeks of exercise training</time_frame>
    <description>Change in peak power output during incremental cycling test on cycle ergometer during the 6 week training period</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in whole-body insulin sensitivity</measure>
    <time_frame>Before and after 6 weeks of exercise training</time_frame>
    <description>Change from baseline in Matsuda index for whole-body insulin sensitivity derived from Oral Glucose Tolerance Test after the 6 week training period</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in microvascular function</measure>
    <time_frame>Before and after 6 weeks of exercise training</time_frame>
    <description>Change from baseline in microvascular function (Single Passive Leg Movement technique) after the 6 week training period</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in skeletal muscle capillarization</measure>
    <time_frame>Before and after 6 weeks of exercise training</time_frame>
    <description>Change from baseline in skeletal muscle capillarization (immunohistochemistry) after the 6 week training period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in skeletal muscle enzyme activity</measure>
    <time_frame>Before and after 6 weeks of exercise training</time_frame>
    <description>Change from baseline in enzyme activity assessment of markers of relevance for skeletal muscle function after the 6 week training period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in skeletal muscle protein content</measure>
    <time_frame>Before and after 6 weeks of exercise training</time_frame>
    <description>Change from baseline in Western Blot assessment of markers of relevance for skeletal muscle function after the 6 week training period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in power output at Gas Exchange Threshold (GET)</measure>
    <time_frame>Before, after 3 weeks and after 6 weeks of exercise training</time_frame>
    <description>Change from baseline in GET during incremental cycling test after the 6 week training period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in power output at Respiratory Compensation Point (RCP)</measure>
    <time_frame>Before, after 3 weeks and after 6 weeks of exercise training</time_frame>
    <description>Change from baseline in RCP during incremental cycling test after the 6 week training period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in time to exhaustion performance test</measure>
    <time_frame>Before, after 3 weeks and after 6 weeks of exercise training</time_frame>
    <description>Change in time to exhaustion test (performed after incremental cycling test) during the 6 week training period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in heart rate during submaximal cycling</measure>
    <time_frame>Before and after 6 weeks of exercise training</time_frame>
    <description>Change from baseline in heart rate during submaximal cycling after the 6 week training period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in substrate oxidation during submaximal cycling</measure>
    <time_frame>Before and after 6 weeks of exercise training</time_frame>
    <description>Change from baseline in substrate oxidation during submaximal cycling test (estimated via gas exchange data) after the 6 week training period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in blood lactate accumulation during submaximal cycling</measure>
    <time_frame>Before and after 6 weeks of exercise training</time_frame>
    <description>Change from baseline in capillary lactate concentration at end of submaximal cycling test after the 6 week training period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in cycling efficiency during submaximal cycling</measure>
    <time_frame>Before and after 6 weeks of exercise training</time_frame>
    <description>Change from baseline in cycling efficiency (estimated via gas exchange data) after the 6 week training period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fasted serum insulin concentrations</measure>
    <time_frame>Before and after 6 weeks of exercise training</time_frame>
    <description>Change from baseline in fasted blood concentrations of insulin after the 6 week training period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fasted serum glucose concentrations</measure>
    <time_frame>Before and after 6 weeks of exercise training</time_frame>
    <description>Change from baseline in fasted blood concentrations of glucose after the 6 week training period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fasted serum cholesterol concentrations</measure>
    <time_frame>Before and after 6 weeks of exercise training</time_frame>
    <description>Change from baseline in fasted blood concentrations of cholesterol after the 6 week training period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fasted serum triglyceride concentrations</measure>
    <time_frame>Before and after 6 weeks of exercise training</time_frame>
    <description>Change from baseline in fasted blood concentrations of triglyceride after the 6 week training period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in resting blood pressure</measure>
    <time_frame>Before and after 6 weeks of exercise training</time_frame>
    <description>Change from baseline in resting mean arterial blood pressure after the 6 week training period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in resting heart rate</measure>
    <time_frame>Before and after 6 weeks of exercise training</time_frame>
    <description>Change from baseline in resting heart rate after the 6 week training period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in body weight</measure>
    <time_frame>Before and after 6 weeks of exercise training</time_frame>
    <description>Change from baseline in total body weight after the 6 week training period</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Exercise Training</condition>
  <condition>Physical Activity</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>6 weeks high-intensity interval training + placebo intake</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Blockade</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>6 weeks high-intensity interval training + histamine H1/H2 receptor blockade</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Lactose</intervention_name>
    <description>Placebo: Lactose capsules</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fexofenadine Hydrochloride</intervention_name>
    <description>H1 receptor antagonist: 540 mg Fexofenadine Hydrochloride</description>
    <arm_group_label>Blockade</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Famotidine</intervention_name>
    <description>H2 receptor antagonist: 40 mg Famotidine</description>
    <arm_group_label>Blockade</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>High-intensity interval training (HIIT)</intervention_name>
    <description>6 weeks HIIT</description>
    <arm_group_label>Blockade</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Sedentary or low levels of physical activity&#xD;
&#xD;
          -  Caucasian&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chronic diseases&#xD;
&#xD;
          -  Medication use&#xD;
&#xD;
          -  Smoking&#xD;
&#xD;
          -  Excessive alcohol consumption&#xD;
&#xD;
          -  Seasonal allergies&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Movement and Sports Sciences, Ghent University</name>
      <address>
        <city>Gent</city>
        <state>Oost-Vlaanderen</state>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 29, 2020</study_first_posted>
  <last_update_submitted>July 29, 2021</last_update_submitted>
  <last_update_submitted_qc>July 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University Ghent</investigator_affiliation>
    <investigator_full_name>Wim Derave</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Exercise</keyword>
  <keyword>Physiology</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fexofenadine</mesh_term>
    <mesh_term>Famotidine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04450134
org study id: HIST-TRAINING
nct id: NCT04450134
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Exercise training is beneficial for both health and performance. Histamine has been shown to
      be involved in the acute exercise response. The current study addresses the role of histamine
      H1/H2 receptor signaling in the chronic training-induced adaptations. Results from this study
      will yield more insights into the molecular mechanisms of adaptations to exercise training.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Placebo + exercise vs histamine blockade + exercise
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Double-blind for researchers and participants
measure: Change in cardiorespiratory fitness
time frame: Before, after 3 weeks and after 6 weeks of exercise training
description: Change in maximal oxygen uptake during incremental cycling test on cycle ergometer during the 6 week training period
measure: Change in peak aerobic power output
time frame: Before, after 3 weeks and after 6 weeks of exercise training
description: Change in peak power output during incremental cycling test on cycle ergometer during the 6 week training period
measure: Change in whole-body insulin sensitivity
time frame: Before and after 6 weeks of exercise training
description: Change from baseline in Matsuda index for whole-body insulin sensitivity derived from Oral Glucose Tolerance Test after the 6 week training period
measure: Change in microvascular function
time frame: Before and after 6 weeks of exercise training
description: Change from baseline in microvascular function (Single Passive Leg Movement technique) after the 6 week training period
measure: Change in skeletal muscle capillarization
time frame: Before and after 6 weeks of exercise training
description: Change from baseline in skeletal muscle capillarization (immunohistochemistry) after the 6 week training period
measure: Change in skeletal muscle enzyme activity
time frame: Before and after 6 weeks of exercise training
description: Change from baseline in enzyme activity assessment of markers of relevance for skeletal muscle function after the 6 week training period
measure: Change in skeletal muscle protein content
time frame: Before and after 6 weeks of exercise training
description: Change from baseline in Western Blot assessment of markers of relevance for skeletal muscle function after the 6 week training period
measure: Change in power output at Gas Exchange Threshold (GET)
time frame: Before, after 3 weeks and after 6 weeks of exercise training
description: Change from baseline in GET during incremental cycling test after the 6 week training period
measure: Change in power output at Respiratory Compensation Point (RCP)
time frame: Before, after 3 weeks and after 6 weeks of exercise training
description: Change from baseline in RCP during incremental cycling test after the 6 week training period
measure: Change in time to exhaustion performance test
time frame: Before, after 3 weeks and after 6 weeks of exercise training
description: Change in time to exhaustion test (performed after incremental cycling test) during the 6 week training period
measure: Change in heart rate during submaximal cycling
time frame: Before and after 6 weeks of exercise training
description: Change from baseline in heart rate during submaximal cycling after the 6 week training period
measure: Change in substrate oxidation during submaximal cycling
time frame: Before and after 6 weeks of exercise training
description: Change from baseline in substrate oxidation during submaximal cycling test (estimated via gas exchange data) after the 6 week training period
measure: Change in blood lactate accumulation during submaximal cycling
time frame: Before and after 6 weeks of exercise training
description: Change from baseline in capillary lactate concentration at end of submaximal cycling test after the 6 week training period
measure: Change in cycling efficiency during submaximal cycling
time frame: Before and after 6 weeks of exercise training
description: Change from baseline in cycling efficiency (estimated via gas exchange data) after the 6 week training period
measure: Change in fasted serum insulin concentrations
time frame: Before and after 6 weeks of exercise training
description: Change from baseline in fasted blood concentrations of insulin after the 6 week training period
measure: Change in fasted serum glucose concentrations
time frame: Before and after 6 weeks of exercise training
description: Change from baseline in fasted blood concentrations of glucose after the 6 week training period
measure: Change in fasted serum cholesterol concentrations
time frame: Before and after 6 weeks of exercise training
description: Change from baseline in fasted blood concentrations of cholesterol after the 6 week training period
measure: Change in fasted serum triglyceride concentrations
time frame: Before and after 6 weeks of exercise training
description: Change from baseline in fasted blood concentrations of triglyceride after the 6 week training period
measure: Change in resting blood pressure
time frame: Before and after 6 weeks of exercise training
description: Change from baseline in resting mean arterial blood pressure after the 6 week training period
measure: Change in resting heart rate
time frame: Before and after 6 weeks of exercise training
description: Change from baseline in resting heart rate after the 6 week training period
measure: Change in body weight
time frame: Before and after 6 weeks of exercise training
description: Change from baseline in total body weight after the 6 week training period
arm group label: Placebo
arm group type: Placebo Comparator
description: 6 weeks high-intensity interval training + placebo intake
arm group label: Blockade
arm group type: Experimental
description: 6 weeks high-intensity interval training + histamine H1/H2 receptor blockade
intervention type: Other
intervention name: Lactose
description: Placebo: Lactose capsules
arm group label: Placebo
intervention type: Drug
intervention name: Fexofenadine Hydrochloride
description: H1 receptor antagonist: 540 mg Fexofenadine Hydrochloride
arm group label: Blockade
intervention type: Drug
intervention name: Famotidine
description: H2 receptor antagonist: 40 mg Famotidine
arm group label: Blockade
intervention type: Other
intervention name: High-intensity interval training (HIIT)
description: 6 weeks HIIT
arm group label: Blockade
arm group label: Placebo
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Belgium
responsible party type: Sponsor-Investigator
investigator affiliation: University Ghent
investigator full name: Wim Derave
investigator title: Professor
mesh term: Fexofenadine
mesh term: Famotidine
sharing ipd: Undecided