NCT02776982

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 16, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 19, 2016

Completed
6 months until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2019

Completed
Last Updated

February 9, 2022

Status Verified

January 1, 2022

Enrollment Period

2.5 years

First QC Date

May 16, 2016

Last Update Submit

January 25, 2022

Conditions

Gastroesophageal RefluxGERD

Keywords

Gastroesophageal reflux diseaseGERDBarrett's EsophagusEsophageal adenocarcinoma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

  • 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

Study Arms (1)

Research procedures

OTHER

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.

Procedure: Confocal endomicroscopyProcedure: Mucosal impedanceProcedure: Research biopsiesProcedure: Bravo ambulatory pH monitor

Interventions

Confocal endomicroscopyPROCEDURE

Confocal endomicroscopy will be performed during clinically indicated endoscopy.

Research procedures
Mucosal impedancePROCEDURE

Mucosal impedance will be performed at the time of clinically indicated endoscopy.

Research procedures
Research biopsiesPROCEDURE

Research biopsies will be obtained during clinically indicated endoscopy.

Research procedures
Bravo ambulatory pH monitorPROCEDURE

Bravo ambulatory pH capsule will be placed during clinically indicated endoscopy.

Research procedures

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related 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.

    PMID: 33955725RESULT

Related Links

MeSH Terms

Conditions

Gastroesophageal RefluxBarrett EsophagusAdenocarcinoma Of Esophagus

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPrecancerous ConditionsNeoplasms

Study Officials

  • Prasad G Iyer, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 16, 2016

First Posted

May 19, 2016

Study Start

November 1, 2016

Primary Completion

May 16, 2019

Study Completion

May 16, 2019

Last Updated

February 9, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)