Anthropometry in Gastroesophageal Reflux Disease and Esophageal Injury

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prasad G. Iyer, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01570842
First received: April 2, 2012
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

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)?


Condition Intervention
Gastroesophageal Reflux Disease (GERD)
Other: Anthropometric measurements
Procedure: Tissue samples

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: The Role of Anthropometry in Gastroesophageal Reflux Disease and Esophageal Injury

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Correlate Anthropometry with number of acid reflux episodes [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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).


Enrollment: 100
Study Start Date: October 2011
Study Completion Date: December 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Anthropometric Measurements; Tissue Samples
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.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01570842

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Prasad G Iyer, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Prasad G. Iyer, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01570842     History of Changes
Other Study ID Numbers: 11-005468
Study First Received: April 2, 2012
Last Updated: March 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Gastroesophageal reflux disease
GERD
Barrett's esophagus

Additional relevant MeSH terms:
Gastroesophageal Reflux
Wounds and Injuries
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 16, 2014