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

Primary Purpose

Esophagitis, Reflux Esophagitis, Gastroesophageal Reflux Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cessation of Acid Suppressing Medications
Sponsored by
Dallas VA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Esophagitis focused on measuring Esophagitis, Reflux esophagitis, Gastroesophageal reflux disease, Acid, Inflammation, Esophagus, Cytokines, Esophageal squamous cell, Reflux, Squamous epithelium

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dallas VA Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Reflux Patients

Arm Description

Patients with reflux and a prior history of reflux esophagitis are being enrolled. The intervention is cessation of acid-suppressing medications.

Outcomes

Primary Outcome Measures

change in esophageal inflammation from baseline to 14 days
inflammation of the squamous esophageal mucosa will be measured at baseline and at 14 days

Secondary Outcome Measures

change in HIF-2a levels from baseline to 14 days
Amount of HIF-2a present will be measured at baseline and at 14 days

Full Information

First Posted
November 16, 2012
Last Updated
February 4, 2020
Sponsor
Dallas VA Medical Center
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT01733810
Brief Title
The Role of HIF-2a in the Pathogenesis of Reflux Esophagitis
Official Title
The Role of HIF-2a in the Pathogenesis of Reflux Esophagitis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2013 (Actual)
Primary Completion Date
July 31, 2015 (Actual)
Study Completion Date
July 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dallas VA Medical Center
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophagitis, Reflux Esophagitis, Gastroesophageal Reflux Disease
Keywords
Esophagitis, Reflux esophagitis, Gastroesophageal reflux disease, Acid, Inflammation, Esophagus, Cytokines, Esophageal squamous cell, Reflux, Squamous epithelium

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Reflux Patients
Arm Type
Experimental
Arm 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(s)
Cessation of Acid Suppressing Medications
Intervention 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.
Primary Outcome Measure Information:
Title
change in esophageal inflammation from baseline to 14 days
Description
inflammation of the squamous esophageal mucosa will be measured at baseline and at 14 days
Time Frame
day 0 and day 14
Secondary Outcome Measure Information:
Title
change in HIF-2a levels from baseline to 14 days
Description
Amount of HIF-2a present will be measured at baseline and at 14 days
Time Frame
day 0 and day 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stuart J Spechler, MD
Organizational Affiliation
Dallas VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dallas VA Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27694141
Citation
Huo X, Agoston AT, Dunbar KB, Cipher DJ, Zhang X, Yu C, Cheng E, Zhang Q, Pham TH, Tambar UK, Bruick RK, Wang DH, Odze RD, Spechler SJ, Souza RF. Hypoxia-inducible factor-2alpha plays a role in mediating oesophagitis in GORD. Gut. 2017 Sep;66(9):1542-1554. doi: 10.1136/gutjnl-2016-312595. Epub 2016 Sep 30.
Results Reference
derived
PubMed Identifier
27187303
Citation
Dunbar KB, Agoston AT, Odze RD, Huo X, Pham TH, Cipher DJ, Castell DO, Genta RM, Souza RF, Spechler SJ. Association of Acute Gastroesophageal Reflux Disease With Esophageal Histologic Changes. JAMA. 2016 May 17;315(19):2104-12. doi: 10.1001/jama.2016.5657.
Results Reference
derived

Learn more about this trial

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

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