<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/NCT01689090</url>
  </required_header>
  <id_info>
    <org_study_id>HypNOCOX</org_study_id>
    <nct_id>NCT01689090</nct_id>
  </id_info>
  <brief_title>Diameter Changes of Retinal Vessels During Hypoxia</brief_title>
  <official_title>Diameter Changes of Retinal Vessels During Hypoxia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Aarhus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Aarhus</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective is to study if an inhibition of nitric oxide and/or prostaglandins&#xD;
      affect the diameter changes of retinal vessels observed during hypoxia. Diameter changes are&#xD;
      studied using the Dynamic Vessel Analyzer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Diameter changes of retinal vessels</measure>
    <time_frame>Examination day 1 and 2</time_frame>
    <description>Comparing the differences of diameter changes occuring during each of the interventions.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">58</enrollment>
  <condition>Diabetes Mellitus Type 1</condition>
  <condition>Diabetic Maculopathy</condition>
  <arm_group>
    <arm_group_label>Hypoxia</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Inhaling hypoxic gas mixture to induce hypoxemia during recordings of diameter changes of retinal vessels. Recording are performed during hypoxia alone and in combination with the associated interventions at two examination days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normoxia</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Breathing atmospheric air during recordings of diameter changes of retinal vessels. Recording are performed during normoxia alone and in combination with the associated interventions at two examination days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>COX inhibitor</intervention_name>
    <description>Administration of 1 drop voltaren 45 minutes before recordings of diameter changes of retinal vessels are initiated</description>
    <arm_group_label>Hypoxia</arm_group_label>
    <arm_group_label>Normoxia</arm_group_label>
    <other_name>Eye drops voltaren 1 mg/ml</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>L-NG-monomethyl arginine citrate</intervention_name>
    <description>Intravenous administration of L-NMMA during recordings of diameter changes of retinal vessels</description>
    <arm_group_label>Hypoxia</arm_group_label>
    <arm_group_label>Normoxia</arm_group_label>
    <other_name>L-NMMA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>COX inhibitor + L-NG-monomethyl arginine citrate</intervention_name>
    <description>Combination of interventions. Administration of an eye drop voltaren and 45 minutes later infusion with L-NMMA is started and recording of diameter changes of retinal vessels is performed</description>
    <arm_group_label>Hypoxia</arm_group_label>
    <arm_group_label>Normoxia</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diabetes type 1 without retinopathy&#xD;
&#xD;
          -  Diabetic retinopathy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cardio-vascular disease&#xD;
&#xD;
          -  Lung disease&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Previous ocular disease other than retinal branch vein occlusion&#xD;
&#xD;
          -  Previous treatment with medications influencing on the intraocular pressure or the&#xD;
             metabolism of nitric oxide or prostaglandins&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Line Pedersen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aarhus University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Ophthalmology, Aarhus University Hospital</name>
      <address>
        <city>Aarhus</city>
        <zip>8000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>August 2015</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>October 11, 2018</last_update_submitted>
  <last_update_submitted_qc>October 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 16, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Macular Degeneration</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
    <mesh_term>Hypoxia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cyclooxygenase Inhibitors</mesh_term>
    <mesh_term>Citric Acid</mesh_term>
    <mesh_term>Sodium Citrate</mesh_term>
    <mesh_term>omega-N-Methylarginine</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/NCT01689090
org study id: HypNOCOX
nct id: NCT01689090
lead sponsor: 
has dmc: No
The primary objective is to study if an inhibition of nitric oxide and/or prostaglandins
      affect the diameter changes of retinal vessels observed during hypoxia. Diameter changes are
      studied using the Dynamic Vessel Analyzer.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Diameter changes of retinal vessels
time frame: Examination day 1 and 2
description: Comparing the differences of diameter changes occuring during each of the interventions.
arm group label: Hypoxia
arm group type: Experimental
description: Inhaling hypoxic gas mixture to induce hypoxemia during recordings of diameter changes of retinal vessels. Recording are performed during hypoxia alone and in combination with the associated interventions at two examination days.
arm group label: Normoxia
arm group type: Experimental
description: Breathing atmospheric air during recordings of diameter changes of retinal vessels. Recording are performed during normoxia alone and in combination with the associated interventions at two examination days.
intervention type: Other
intervention name: COX inhibitor
description: Administration of 1 drop voltaren 45 minutes before recordings of diameter changes of retinal vessels are initiated
arm group label: Hypoxia
arm group label: Normoxia
other name: Eye drops voltaren 1 mg/ml
intervention type: Other
intervention name: L-NG-monomethyl arginine citrate
description: Intravenous administration of L-NMMA during recordings of diameter changes of retinal vessels
arm group label: Hypoxia
arm group label: Normoxia
other name: L-NMMA
intervention type: Other
intervention name: COX inhibitor + L-NG-monomethyl arginine citrate
description: Combination of interventions. Administration of an eye drop voltaren and 45 minutes later infusion with L-NMMA is started and recording of diameter changes of retinal vessels is performed
arm group label: Hypoxia
arm group label: Normoxia
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Line Pedersen, MD
role: Principal Investigator
affiliation: Aarhus University Hospital
facility: 
country: Denmark
responsible party type: Sponsor
mesh term: Macular Degeneration
mesh term: Diabetes Mellitus, Type 1
mesh term: Hypoxia
mesh term: Cyclooxygenase Inhibitors
mesh term: Citric Acid
mesh term: Sodium Citrate
mesh term: omega-N-Methylarginine