Influence of Central Obesity on the Esophageal Epithelial Barrier

Not Applicable

Completed

• Conditions: Gastroesophageal Reflux; GERD
• Interventions: Procedure: Confocal endomicroscopy; Procedure: Mucosal impedance; Procedure: Research biopsies; Procedure: Bravo ambulatory pH monitor

• Registration Number: NCT02776982
• Lead Sponsor: Mayo Clinic

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-16
• Study First Submitted QC: 2016-05-17
• Study First Posted: 2016-05-19
• Study Start: 2016-11
• Primary Completion: 2019-05-16
• Study Completion: 2019-05-16
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-25
• Last Update Posted: 2022-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

1. Pre-existing or suspected Barrett's Esophagus (> 1cm of columnar mucosa in esophagus on endoscopy
2. Oral anticoagulation precluding endoscopic biopsies
3. Patients with known hypersensitivity to fluorescein sodium.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Research procedures	Confocal endomicroscopy	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.
Research procedures	Mucosal impedance	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.
Research procedures	Research biopsies	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.
Research procedures	Bravo ambulatory pH monitor	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States