Anthropometry in Gastroesophageal Reflux Disease and Esophageal Injury
The Role of Anthropometry in Gastroesophageal Reflux Disease and Esophageal Injury
1 other identifier
interventional
100
1 country
1
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)?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 2, 2012
CompletedFirst Posted
Study publicly available on registry
April 4, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedMarch 31, 2014
March 1, 2014
1.1 years
April 2, 2012
March 28, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
1 year
Study Arms (1)
Anthropometric Measurements; Tissue Samples
OTHERAll 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Subjects with a prior history of esophageal surgery, or diagnosis of BE.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55905, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Prasad G Iyer, MD
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
April 2, 2012
First Posted
April 4, 2012
Study Start
October 1, 2011
Primary Completion
November 1, 2012
Study Completion
December 1, 2012
Last Updated
March 31, 2014
Record last verified: 2014-03