Influence of Central Obesity on the Esophageal Epithelial Barrier

NCT ID: NCT02776982

Last Updated: 2022-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2019-05-16

Brief Summary

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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

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Conditions

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Gastroesophageal Reflux GERD

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Research procedures

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.

Group Type OTHER

Confocal endomicroscopy

Intervention Type PROCEDURE

Confocal endomicroscopy will be performed during clinically indicated endoscopy.

Mucosal impedance

Intervention Type PROCEDURE

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

Research biopsies

Intervention Type PROCEDURE

Research biopsies will be obtained during clinically indicated endoscopy.

Bravo ambulatory pH monitor

Intervention Type PROCEDURE

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

Interventions

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Confocal endomicroscopy

Confocal endomicroscopy will be performed during clinically indicated endoscopy.

Intervention Type PROCEDURE

Mucosal impedance

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

Intervention Type PROCEDURE

Research biopsies

Research biopsies will be obtained during clinically indicated endoscopy.

Intervention Type PROCEDURE

Bravo ambulatory pH monitor

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Prasad G. Iyer

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Prasad G Iyer, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 33955725 (View on PubMed)

Related Links

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Other Identifiers

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16-001069

Identifier Type: -

Identifier Source: org_study_id

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