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NCT Number: NCT00698178

Waist Circumference Versus Body Mass Index to Predict Severity of Gastroesophageal Reflux Disease

Gastroesophageal reflux disease (GERD) is a common and important disorder. Previous studies have demonstrated the association of obesity with GERD, and now obesity is regarded as a risk factor for GERD. Moreover, body mass index (BMI), an indicator of general obesity, correlates with severity of symptoms and degree of erosive esophagitis. Waist circumference, an indicator of abdominal obesity, has stronger correlation with intra-abdominal pressure and low-grade inflammatory state when compared with BMI. Nevertheless the association of waist circumference with severity of GERD has not been studied.

The primary aim of this study is to compare BMI with waist circumference for their independent association with severity of GERD. The secondary aim is to evaluate independent risk factors of severity of GERD.

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Key information

About this study

This is a cross-section observational study. Outpatients presenting with acid reflux or heart burn are interviewed with standardized questionnaire to quantify severity of symptoms. The eligible patients undergo upper endoscopy to diagnose erosive esophagitis and further classify the degree of erosions according to Los-Angels classification. Enrolled patients receive anthropometric measurements to record body weight, body height and waist circumference on the day of enrollment.

Two outcomes are studied: the severity of GERD symptoms and the Los-Angels Classification of erosive esophagitis.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age more than 20 years old and less than 70 years old
  • typical gastroesophageal reflux symptoms (heart burn and acid reflux)
  • outpatient
  • complete upper gastrointestinal endoscopy

Exclusion criteria

  • age less than 20 years or more than 70 years old
  • receive medication for reflux disease (including proton pump inhibitor, histamine type 2 receptor blocker, prokinetic agents) in previous one month
  • pregnant women
  • history of abdominal surgery
  • severe comorbidity with cirrhosis, end-stage renal disease, heart failure
  • no written informed consent

Treatment and study plan

Anthropometric measurements

Other

All patients undergo anthropometric measurements to record body weight, body height and waist circumference on the day of enrollment

Primary outcomes

  1. the degree fo erosive esophagitis according to Los-Angels classification

    Time frame: on the day of endoscopy examination

Secondary outcomes

  1. gastro-reflux severity score as evaluated by standardized questionnaire

    Time frame: at enrollment (before upper GI endoscopy)

Sponsors and collaborators

Lead sponsor

Lotung Poh-Ai Hospital

Other

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jun 17, 2008
Registry last updated
Oct 19, 2010

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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