Influence of Central Obesity on the Esophageal Epithelial Barrier

Sponsor

Mayo Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT02776982

Collaborator

(none)

Enrollment

Location

Arm

30.4

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Gastroesophageal Reflux GERD	Procedure: Confocal endomicroscopy Procedure: Mucosal impedance Procedure: Research biopsies Procedure: Bravo ambulatory pH monitor	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

38 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Influence of Central Obesity on the Esophageal Epithelial Barrier

Study Start Date :

Nov 1, 2016

Actual Primary Completion Date :

May 16, 2019

Actual Study Completion Date :

May 16, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.	Procedure: Confocal endomicroscopy Confocal endomicroscopy will be performed during clinically indicated endoscopy. Procedure: Mucosal impedance Mucosal impedance will be performed at the time of clinically indicated endoscopy. Procedure: Research biopsies Research biopsies will be obtained during clinically indicated endoscopy. Procedure: Bravo ambulatory pH monitor Bravo ambulatory pH capsule will be placed during clinically indicated endoscopy.

Arm

Intervention/Treatment

Other: 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.

Procedure: Confocal endomicroscopy

Confocal endomicroscopy will be performed during clinically indicated endoscopy.

Procedure: Mucosal impedance

Mucosal impedance will be performed at the time of clinically indicated endoscopy.

Procedure: Research biopsies

Research biopsies will be obtained during clinically indicated endoscopy.

Procedure: Bravo ambulatory pH monitor

Bravo ambulatory pH capsule will be placed during clinically indicated endoscopy.

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

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.