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

NCT ID: NCT01733810

Last Updated: 2020-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-01

Study Completion Date

2019-07-31

Brief Summary

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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

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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.

Conditions

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Esophagitis Reflux Esophagitis Gastroesophageal Reflux Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Reflux Patients

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

Group Type EXPERIMENTAL

Cessation of Acid Suppressing Medications

Intervention Type OTHER

Acid-suppressing medications are stopped for all participants the day after baseline assessment. Subsequent evaluations performed while participant is not on acid-suppressing medications.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

NIH

Sponsor Role collaborator

Dallas VA Medical Center

FED

Sponsor Role lead

Responsible Party

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Stuart Spechler

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stuart J Spechler, MD

Role: PRINCIPAL_INVESTIGATOR

Dallas VA Medical Center

Locations

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Dallas VA Medical Center

Dallas, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 27694141 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27187303 (View on PubMed)

Other Identifiers

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R01DK063621

Identifier Type: NIH

Identifier Source: secondary_id

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2R01DK063621-11

Identifier Type: NIH

Identifier Source: org_study_id

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