Back to resultsInfluence of Central Obesity on the Esophageal Epithelial Barrier
Primary Purpose
Gastroesophageal Reflux, GERD
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Confocal endomicroscopy
Mucosal impedance
Research biopsies
Bravo ambulatory pH monitor
Sponsored by
About this trial
This is an interventional diagnostic trial for Gastroesophageal Reflux focused on measuring Gastroesophageal reflux disease, GERD, Barrett's Esophagus, Esophageal adenocarcinoma
Eligibility Criteria
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.
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Research procedures
Arm 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02776982
Brief Title
Influence of Central Obesity on the Esophageal Epithelial Barrier
Official Title
Influence of Central Obesity on the Esophageal Epithelial Barrier
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
November 2016 (undefined)
Primary Completion Date
May 16, 2019 (Actual)
Study Completion Date
May 16, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux, GERD
Keywords
Gastroesophageal reflux disease, GERD, Barrett's Esophagus, Esophageal adenocarcinoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Research procedures
Arm Type
Other
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Confocal endomicroscopy
Intervention Description
Confocal endomicroscopy will be performed during clinically indicated endoscopy.
Intervention Type
Procedure
Intervention Name(s)
Mucosal impedance
Intervention Description
Mucosal impedance will be performed at the time of clinically indicated endoscopy.
Intervention Type
Procedure
Intervention Name(s)
Research biopsies
Intervention Description
Research biopsies will be obtained during clinically indicated endoscopy.
Intervention Type
Procedure
Intervention Name(s)
Bravo ambulatory pH monitor
Intervention Description
Bravo ambulatory pH capsule will be placed during clinically indicated endoscopy.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prasad G Iyer, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33955725
Citation
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.
Results Reference
result
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Influence of Central Obesity on the Esophageal Epithelial Barrier
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