Influence of Central Obesity on the Esophageal Epithelial Barrier

Gastroesophageal Reflux Clinical Trial

Official title:

Influence of Central Obesity on the Esophageal Epithelial Barrier

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02776982
• Other study ID #: 16-001069
• Status: Completed
• Phase: N/A
• Start date: November 2016
• Est. completion date: May 16, 2019

Study information

• Verified date: January 2022
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: May 16, 2019
• Est. primary completion date: May 16, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• GERD
• Obesity, Abdominal

Intervention

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

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

References & Publications (1)

Gibbens YY, Lansing R, Johnson ML, Blevins CH, Katzka DA, Iyer PG. Effects of Central Obesity on Esophageal Epithelial Barrier Function. Am J Gastroenterol. 2021 Jul 1;116(7):1537-1541. doi: 10.14309/ajg.0000000000001196. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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

External Links

•   Mayo Clinic Clinical Trials