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OpenTrials
Completed

NCT Number: NCT02776982

Influence of Central Obesity on the Esophageal Epithelial Barrier

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).

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Key information

Conditions

Gastroesophageal Reflux Adenocarcinoma Of Esophagus Barrett Esophagus Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders GERD Gastrointestinal Diseases Neoplasms Precancerous Conditions

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Confocal endomicroscopy

Procedure

Confocal endomicroscopy will be performed during clinically indicated endoscopy.

Mucosal impedance

Procedure

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

Research biopsies

Procedure

Research biopsies will be obtained during clinically indicated endoscopy.

Bravo ambulatory pH monitor

Procedure

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

Primary outcomes

  1. 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

  1. 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.

    Time frame: One year

  2. 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.

    Time frame: One year

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
May 19, 2016
Registry last updated
Feb 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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