Influence of Central Obesity on the Esophageal Epithelial Barrier

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02776982

Enrollment

Registered

2016-05-19

Start date

2016-11-30

Completion date

2019-05-16

Last updated

2022-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal Reflux, GERD

Keywords

Gastroesophageal reflux disease, GERD, Barrett's Esophagus, Esophageal adenocarcinoma

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).

Interventions

PROCEDUREConfocal endomicroscopy

Confocal endomicroscopy will be performed during clinically indicated endoscopy.

PROCEDUREMucosal impedance

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

PROCEDUREResearch biopsies

Research biopsies will be obtained during clinically indicated endoscopy.

PROCEDUREBravo ambulatory pH monitor

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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

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.

Design outcomes

Primary

Measure	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

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026