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The Role of HIF-2a in the Pathogenesis of Reflux Esophagitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01733810
Recruitment Status : Active, not recruiting
First Posted : November 27, 2012
Last Update Posted : August 2, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Esophagitis Reflux Esophagitis Gastroesophageal Reflux Disease Other: Cessation of Acid Suppressing Medications

Detailed Description:
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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Role of HIF-2a in the Pathogenesis of Reflux Esophagitis
Study Start Date : February 2013
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Reflux Patients
Patients with reflux and a prior history of reflux esophagitis are being enrolled. The intervention is cessation of acid-suppressing medications.
Other: Cessation of Acid Suppressing Medications
Acid-suppressing medications are stopped for all participants the day after baseline assessment. Subsequent evaluations performed while participant is not on acid-suppressing medications.

Outcome Measures

Primary Outcome Measures :
  1. change in esophageal inflammation from baseline to 14 days [ Time Frame: day 0 and day 14 ]
    inflammation of the squamous esophageal mucosa will be measured at baseline and at 14 days

Secondary Outcome Measures :
  1. change in HIF-2a levels from baseline to 14 days [ Time Frame: day 0 and day 14 ]
    Amount of HIF-2a present will be measured at baseline and at 14 days

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • U.S Veteran
  • History of Los Angeles Grade C erosive esophagitis

Exclusion Criteria:

  • Inability to provide informed consent
  • Esophageal varices
  • Warfarin use
  • Coagulopathy that precludes safe biopsy of the esophagus
  • Comorbidity that precludes safe participation in the study
  • Allergy to fluorescein sodium
  • Pregnancy
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01733810

United States, Texas
Dallas VA Medical Center
Dallas, Texas, United States, 75216
Sponsors and Collaborators
Dallas VA Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Stuart J Spechler, MD Dallas VA Medical Center
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stuart Spechler, Professor of Medicine, Dallas VA Medical Center
ClinicalTrials.gov Identifier: NCT01733810     History of Changes
Other Study ID Numbers: 2R01DK063621-11 ( U.S. NIH Grant/Contract )
R01DK063621 ( U.S. NIH Grant/Contract )
First Posted: November 27, 2012    Key Record Dates
Last Update Posted: August 2, 2016
Last Verified: August 2016

Keywords provided by Stuart Spechler, Dallas VA Medical Center:
Reflux esophagitis
Gastroesophageal reflux disease
Esophageal squamous cell
Squamous epithelium

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophagitis, Peptic
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases