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Anthropometry in Gastroesophageal Reflux Disease and Esophageal Injury

Primary Purpose

Gastroesophageal Reflux Disease (GERD)

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Anthropometric measurements
Tissue samples
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Gastroesophageal Reflux Disease (GERD) focused on measuring Gastroesophageal reflux disease, GERD, Barrett's esophagus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion:

  • Subjects over the age of 18 undergoing clinically indicated 24 hour pH impedance and/or pH studies. Many will also undergo clinically indicated endoscopy, and consent for acquiring tissue samples for future biomarker staining tests will be obtained.
  • Able to give informed consent

Exclusion:

  • Subjects with a prior history of esophageal surgery, or diagnosis of BE.

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Anthropometric Measurements; Tissue Samples

Arm Description

All participants will have their waist circumference and waist to hip ratio taken as a measurement of central obesity. Participants undergoing clinically indicated upper endoscopy and who consent to providing tissue samples will have 8 tissue samples taken for future research purposes.

Outcomes

Primary Outcome Measures

Correlate Anthropometry with number of acid reflux episodes
To correlate measures of central obesity waist/hip ratio (WHR) and waist circumference (WC) with number of reflux episodes (acidic and non acidic), and other measures of acid/non acid reflux. Stratify by use of proton pump inhibitors (PPIs).

Secondary Outcome Measures

Full Information

First Posted
April 2, 2012
Last Updated
March 28, 2014
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT01570842
Brief Title
Anthropometry in Gastroesophageal Reflux Disease and Esophageal Injury
Official Title
The Role of Anthropometry in Gastroesophageal Reflux Disease and Esophageal Injury
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Is waist to hip ratio (WHR), waist circumference (WC), (as markers of visceral adiposity) associated with an increase in acidic and non acidic reflux as well as systemic inflammation involving esophageal mucosa, thereby increasing esophageal injury and predisposing to subsequent development of Barrett's esophagus (BE)?
Detailed Description
The investigators will study 100 adult subjects over the age of 18 from the esophageal motility lab who are undergoing clinically indicated 24 hour acidity or basicity (pH) impedance and/or pH studies off acid suppressing medication.. These subjects will not have a prior history of esophageal surgery, or diagnosis of BE. The investigators will obtain consent for taking anthropometric measurements (Waist and hip circumference), and the results of their study. Only those subjects that successfully complete the 24 hour pH impedance studies will be included. Subjects will also undergo clinically indicated endoscopy. The investigators will consent these subjects to obtain 4 biopsies (bx) from the gastroesophageal (GE) junction and 4 bx from 5 cm above the GE junction. These bio-specimens will be stored for assessment of tissue injury (PGE2) and tissue immune-histochemistry of BE precursors (CDX1 and CDX2) at a later date.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease (GERD)
Keywords
Gastroesophageal reflux disease, GERD, Barrett's esophagus

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anthropometric Measurements; Tissue Samples
Arm Type
Other
Arm Description
All participants will have their waist circumference and waist to hip ratio taken as a measurement of central obesity. Participants undergoing clinically indicated upper endoscopy and who consent to providing tissue samples will have 8 tissue samples taken for future research purposes.
Intervention Type
Other
Intervention Name(s)
Anthropometric measurements
Intervention Description
All participants will have their waist circumference and waist to hip ratio taken as a measurement of central obesity.
Intervention Type
Procedure
Intervention Name(s)
Tissue samples
Intervention Description
Participants undergoing clinically indicated upper endoscopy and who consent to providing tissue samples will have 8 tissue samples taken for future research purposes.
Primary Outcome Measure Information:
Title
Correlate Anthropometry with number of acid reflux episodes
Description
To correlate measures of central obesity waist/hip ratio (WHR) and waist circumference (WC) with number of reflux episodes (acidic and non acidic), and other measures of acid/non acid reflux. Stratify by use of proton pump inhibitors (PPIs).
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion: Subjects over the age of 18 undergoing clinically indicated 24 hour pH impedance and/or pH studies. Many will also undergo clinically indicated endoscopy, and consent for acquiring tissue samples for future biomarker staining tests will be obtained. Able to give informed consent Exclusion: Subjects with a prior history of esophageal surgery, or diagnosis of BE.
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

Learn more about this trial

Anthropometry in Gastroesophageal Reflux Disease and Esophageal Injury

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