Influence of Central Obesity on the Esophageal Epithelial Barrier
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Compare intercellular space dilation as a marker for apical junction complex integrity in esophageal squamous epithelium by using transmission electron microscopy in those patients with/without gastroesophageal reflux and with/without central obesity.
Study Overview
Brief Summary
This study is being done to help understand why some people with an increased amount of central obesity, without gastroesophageal reflux, develop changes to the lining of their esophagus that can potentially lead to esophageal adenocarcinoma (cancer).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Participants who are undergoing clinically indicated upper endoscopy with Bravo ambulatory pH capsule (off reflux medications for 7 days), in the Esophageal Clinic at Mayo Clinic.
Exclusion Criteria
- •Pre-existing or suspected Barrett's Esophagus (> 1cm of columnar mucosa in esophagus on endoscopy
- •Oral anticoagulation precluding endoscopic biopsies
- •Patients with known hypersensitivity to fluorescein sodium.
Arms & Interventions
Research procedures
Participants enrolled in study will have confocal endomicroscopy, research biopsies, mucosal impedance, and Bravo ambulatory pH capsule performed at the time of clinically indicated endoscopy.
Intervention: Confocal endomicroscopy (Procedure)
Research procedures
Participants enrolled in study will have confocal endomicroscopy, research biopsies, mucosal impedance, and Bravo ambulatory pH capsule performed at the time of clinically indicated endoscopy.
Intervention: Mucosal impedance (Procedure)
Research procedures
Participants enrolled in study will have confocal endomicroscopy, research biopsies, mucosal impedance, and Bravo ambulatory pH capsule performed at the time of clinically indicated endoscopy.
Intervention: Research biopsies (Procedure)
Research procedures
Participants enrolled in study will have confocal endomicroscopy, research biopsies, mucosal impedance, and Bravo ambulatory pH capsule performed at the time of clinically indicated endoscopy.
Intervention: Bravo ambulatory pH monitor (Procedure)
Outcomes
Primary Outcomes
Compare intercellular space dilation as a marker for apical junction complex integrity in esophageal squamous epithelium by using transmission electron microscopy in those patients with/without gastroesophageal reflux and with/without central obesity.
Time Frame: One year
Secondary Outcomes
- Compare the prostaglandin E2 level as measured by enzyme immunoassay in esophageal squamous epithelium in those patients with/without gastroesophageal reflux and with/without central obesity.(One year)
- Compare paracellular permeability of esophageal squamous epithelium by measuring mucosal impedance and IV fluorescein leak using a confocal laser endomicroscope in those patients with/without gastroesophageal reflux and with/without central obesity.(One year)
Investigators
Prasad G. Iyer
MD
Mayo Clinic