Influence of Central Obesity on the Esophageal Epithelial Barrier

Mayo Clinic

Status: Completed

Conditions: Gastroesophageal Reflux; GERD

Treatments: Procedure: Mucosal impedance; Procedure: Confocal endomicroscopy; Procedure: Bravo ambulatory pH monitor; Procedure: Research biopsies

Study type: Interventional

Funder types: Other

Identifiers

NCT02776982

16-001069

Details and patient eligibility

About

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).

Enrollment: 38 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

Research procedures

Other group

Description:

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.

Treatment:

Procedure: Mucosal impedance

Procedure: Research biopsies

Procedure: Bravo ambulatory pH monitor

Procedure: Confocal endomicroscopy