Influence of Central Obesity on the Esophageal Epithelial Barrier

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).

Official Title
-----------------
Influence of Central Obesity on the Esophageal Epithelial Barrier

Conditions
-----------------
GERD, Gastroesophageal Reflux

Intervention / Treatment
-----------------
* Procedure: Confocal endomicroscopy
* Procedure: Mucosal impedance
* Procedure: Research biopsies
* Procedure: Bravo ambulatory pH monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Research procedures<br>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. | Procedure: Confocal endomicroscopy<br>* Confocal endomicroscopy will be performed during clinically indicated endoscopy.<br>Procedure: Mucosal impedance<br>* Mucosal impedance will be performed at the time of clinically indicated endoscopy.<br>Procedure: Research biopsies<br>* Research biopsies will be obtained during clinically indicated endoscopy.<br>Procedure: Bravo ambulatory pH monitor<br>* Bravo ambulatory pH capsule will be placed during clinically indicated endoscopy.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastroesophageal reflux disease, GERD, Barrett's Esophagus, Esophageal adenocarcinoma