Clinical trial · Interventional
Influence of Central Obesity on the Esophageal Epithelial Barrier
NCT02776982CI-TRIAL-00056430completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastroesophageal Reflux | — | UNRESOLVED | — |
| GERD | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bravo ambulatory pH monitor | Procedure | — | UNRESOLVED |
| Confocal endomicroscopy | Procedure | — | UNRESOLVED |
| Mucosal impedance | Procedure | — | UNRESOLVED |
| Research biopsies | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Research procedures
- 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.
- interventionNames
- Procedure: Confocal endomicroscopy
- Procedure: Mucosal impedance
- Procedure: Research biopsies
- Procedure: Bravo ambulatory pH monitor
Primary outcomes (1)
- measure
- 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.
- timeFrame
- One year
Secondary outcomes (2)
- measure
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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.
References
Publications (1)
- RESULTGibbens 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. PMID 33955725