<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/NCT01733810</url>
  </required_header>
  <id_info>
    <org_study_id>2R01DK063621-11</org_study_id>
    <secondary_id>R01DK063621</secondary_id>
    <nct_id>NCT01733810</nct_id>
  </id_info>
  <brief_title>The Role of HIF-2a in the Pathogenesis of Reflux Esophagitis</brief_title>
  <official_title>The Role of HIF-2a in the Pathogenesis of Reflux Esophagitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dallas VA Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Dallas VA Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the role of hypoxia inducible factor (HIF)-2a on&#xD;
      the production of inflammatory cytokines that lead to reflux esophagitis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Reflux esophagitis is thought to be caused by gastric acid that refluxes into the esophagus,&#xD;
      causing injury. Newer data suggest that reflux of gastric juice into the esophagus stimulates&#xD;
      HIF-2a, which increases production of inflammatory cytokines. These cytokines are thought to&#xD;
      lead to reflux esophagitis. The investigators plan to study the relationship of HIF-2a to&#xD;
      inflammatory cytokines in patients with known gastroesophageal reflux disease and reflux&#xD;
      esophagitis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2013</start_date>
  <completion_date type="Actual">July 31, 2019</completion_date>
  <primary_completion_date type="Actual">July 31, 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change in esophageal inflammation from baseline to 14 days</measure>
    <time_frame>day 0 and day 14</time_frame>
    <description>inflammation of the squamous esophageal mucosa will be measured at baseline and at 14 days</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>change in HIF-2a levels from baseline to 14 days</measure>
    <time_frame>day 0 and day 14</time_frame>
    <description>Amount of HIF-2a present will be measured at baseline and at 14 days</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Esophagitis</condition>
  <condition>Reflux Esophagitis</condition>
  <condition>Gastroesophageal Reflux Disease</condition>
  <arm_group>
    <arm_group_label>Reflux Patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with reflux and a prior history of reflux esophagitis are being enrolled. The intervention is cessation of acid-suppressing medications.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cessation of Acid Suppressing Medications</intervention_name>
    <description>Acid-suppressing medications are stopped for all participants the day after baseline assessment. Subsequent evaluations performed while participant is not on acid-suppressing medications.</description>
    <arm_group_label>Reflux Patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  U.S Veteran&#xD;
&#xD;
          -  History of Los Angeles Grade C erosive esophagitis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to provide informed consent&#xD;
&#xD;
          -  Esophageal varices&#xD;
&#xD;
          -  Warfarin use&#xD;
&#xD;
          -  Coagulopathy that precludes safe biopsy of the esophagus&#xD;
&#xD;
          -  Comorbidity that precludes safe participation in the study&#xD;
&#xD;
          -  Allergy to fluorescein sodium&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stuart J Spechler, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dallas VA Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dallas VA Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>November 16, 2012</study_first_submitted>
  <study_first_submitted_qc>November 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 27, 2012</study_first_posted>
  <last_update_submitted>February 4, 2020</last_update_submitted>
  <last_update_submitted_qc>February 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dallas VA Medical Center</investigator_affiliation>
    <investigator_full_name>Stuart Spechler</investigator_full_name>
    <investigator_title>Professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>Esophagitis</keyword>
  <keyword>Reflux esophagitis</keyword>
  <keyword>Gastroesophageal reflux disease</keyword>
  <keyword>Acid</keyword>
  <keyword>Inflammation</keyword>
  <keyword>Esophagus</keyword>
  <keyword>Cytokines</keyword>
  <keyword>Esophageal squamous cell</keyword>
  <keyword>Reflux</keyword>
  <keyword>Squamous epithelium</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastroesophageal Reflux</mesh_term>
    <mesh_term>Esophagitis, Peptic</mesh_term>
    <mesh_term>Esophagitis</mesh_term>
  </condition_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/NCT01733810
org study id: 2R01DK063621-11
secondary id: R01DK063621
nct id: NCT01733810
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to determine the role of hypoxia inducible factor (HIF)-2a on
      the production of inflammatory cytokines that lead to reflux esophagitis.
Reflux esophagitis is thought to be caused by gastric acid that refluxes into the esophagus,
      causing injury. Newer data suggest that reflux of gastric juice into the esophagus stimulates
      HIF-2a, which increases production of inflammatory cytokines. These cytokines are thought to
      lead to reflux esophagitis. The investigators plan to study the relationship of HIF-2a to
      inflammatory cytokines in patients with known gastroesophageal reflux disease and reflux
      esophagitis.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: change in esophageal inflammation from baseline to 14 days
time frame: day 0 and day 14
description: inflammation of the squamous esophageal mucosa will be measured at baseline and at 14 days
measure: change in HIF-2a levels from baseline to 14 days
time frame: day 0 and day 14
description: Amount of HIF-2a present will be measured at baseline and at 14 days
arm group label: Reflux Patients
arm group type: Experimental
description: Patients with reflux and a prior history of reflux esophagitis are being enrolled. The intervention is cessation of acid-suppressing medications.
intervention type: Other
intervention name: Cessation of Acid Suppressing Medications
description: Acid-suppressing medications are stopped for all participants the day after baseline assessment. Subsequent evaluations performed while participant is not on acid-suppressing medications.
arm group label: Reflux Patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stuart J Spechler, MD
role: Principal Investigator
affiliation: Dallas VA Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Dallas VA Medical Center
investigator full name: Stuart Spechler
investigator title: Professor of Medicine
mesh term: Gastroesophageal Reflux
mesh term: Esophagitis, Peptic
mesh term: Esophagitis