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

February 4, 2020 updated by: Stuart Spechler, Dallas VA Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75216
        • Dallas VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
day 0 and day 14

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
day 0 and day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dallas VA Medical Center

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2013

Primary Completion (Actual)

July 31, 2015

Study Completion (Actual)

July 31, 2019

Study Registration Dates

First Submitted

November 16, 2012

First Submitted That Met QC Criteria

November 21, 2012

First Posted (Estimate)

November 27, 2012

Study Record Updates

Last Update Posted (Actual)

February 5, 2020

Last Update Submitted That Met QC Criteria

February 4, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2R01DK063621-11 (U.S. NIH Grant/Contract)
  • R01DK063621 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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