Influence of Central Obesity on the Esophageal Epithelial Barrier
Not Applicable
Completed
- Conditions
- Gastroesophageal RefluxGERD
- 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
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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- 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
Mayo Clinic🇺🇸Rochester, Minnesota, United States