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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Dallas VA Medical Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Stuart Spechler, Dallas VA Medical Center
ClinicalTrials.gov Identifier:
NCT01733810
First received: November 16, 2012
Last updated: February 27, 2013
Last verified: February 2013
  Purpose

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 Intervention
Esophagitis
Reflux Esophagitis
Gastroesophageal Reflux Disease
Other: Cessation of Acid Suppressing Medications

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: The Role of HIF-2a in the Pathogenesis of Reflux Esophagitis

Resource links provided by NLM:


Further study details as provided by Dallas VA Medical Center:

Primary Outcome Measures:
  • change in esophageal inflammation from baseline to 14 days [ Time Frame: day 0 and day 14 ] [ Designated as safety issue: No ]
    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 [ Time Frame: day 0 and day 14 ] [ Designated as safety issue: No ]
    Amount of HIF-2a present will be measured at baseline and at 14 days


Estimated Enrollment: 15
Study Start Date: February 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01733810

Contacts
Contact: Kerry B. Dunbar, MD, PhD 214-857-1603 Kerry.Dunbar@va.gov
Contact: Stuart J. Spechler, MD 214-857-1603 Stuart.Spechler@va.gov

Locations
United States, Texas
Dallas VA Medical Center Recruiting
Dallas, Texas, United States, 75216
Principal Investigator: Stuart J. Spechler, MD         
Sub-Investigator: Kerry B. Dunbar, MD, PhD         
Sub-Investigator: Rhonda Souza, MD         
Dallas VA Medical Center Recruiting
Dallas, Texas, United States, 75216
Contact: Kerry B. Dunbar, MD, MPH    214-857-1603    Kerry.Dunbar@va.gov   
Contact: Stuart J Spechler, MD    214-857-1603    Stuart.Spechler@va.gov   
Sub-Investigator: Ronda Souza, MD         
Sub-Investigator: Kerry B. Dunbar, MD, PhD         
Sponsors and Collaborators
Dallas VA Medical Center
Investigators
Principal Investigator: Stuart J Spechler, MD Dallas VA Medical Center
  More Information

No publications provided

Responsible Party: Stuart Spechler, Professor of Medicine, Dallas VA Medical Center
ClinicalTrials.gov Identifier: NCT01733810     History of Changes
Other Study ID Numbers: 2R01DK063621-11, R01DK063621
Study First Received: November 16, 2012
Last Updated: February 27, 2013
Health Authority: United States: Federal Government

Keywords provided by Dallas VA Medical Center:
Esophagitis
Reflux esophagitis
Gastroesophageal reflux disease
Acid
Inflammation
Esophagus
Cytokines
Esophageal squamous cell
Reflux
Squamous epithelium

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

ClinicalTrials.gov processed this record on July 22, 2014