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OpenTrials
Completed

NCT Number: NCT01570842

Anthropometry in Gastroesophageal Reflux Disease and Esophageal Injury

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)?

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Key information

Conditions

Gastroesophageal Reflux Disease (GERD) Barrett Esophagus Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Neoplasms Precancerous Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Anthropometric measurements

Other

All participants will have their waist circumference and waist to hip ratio taken as a measurement of central obesity.

Tissue samples

Procedure

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

Primary outcomes

  1. Correlate Anthropometry with number of acid reflux episodes

    Time frame: 1 year

    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).

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

The Role of Anthropometry in Gastroesophageal Reflux Disease and Esophageal Injury

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 4, 2012
Registry last updated
Mar 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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