Anthropometry in Gastroesophageal Reflux Disease and Esophageal Injury

Gastroesophageal Reflux Disease (GERD) Clinical Trial

Official title:

The Role of Anthropometry in Gastroesophageal Reflux Disease and Esophageal Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01570842
• Other study ID #: 11-005468
• Status: Completed
• Phase: N/A
• First received: April 2, 2012
• Last updated: March 28, 2014
• Start date: October 2011
• Est. completion date: December 2012

Study information

• Verified date: March 2014
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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)?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease (GERD)

Intervention

Other:
• Anthropometric measurements
All participants will have their waist circumference and waist to hip ratio taken as a measurement of central obesity.

Procedure:
• Tissue samples
Participants undergoing clinically indicated upper endoscopy and who consent to providing tissue samples will have 8 tissue samples taken for future research purposes.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No