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CompletedNCT00698178Updated Oct 19, 2010

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

An observational study in Gastroesophageal Reflux Disease and Obesity, sponsored by Lotung Poh-Ai Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2010-10-19.

Sponsored by Lotung Poh-Ai Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
500
Ages
20 Years to 70 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Gastroesophageal Reflux Disease
  • Obesity

Keywords

  • Gastroesophageal reflux disease
  • Waist circumference
  • Body mass index
  • Obesity
03

In context

Gastroesophageal Reflux

1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.

This study's planned enrollment of 500 is above the median of 180 across 298 observational studies indexed under Gastroesophageal Reflux.

Browse Gastroesophageal Reflux studies →

Lead sponsor

Lotung Poh-Ai Hospital is the lead sponsor of 10 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Outpatients at a general hospital with 1000 beds in north-eastern Taiwan

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

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
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
500 participants (estimated)

Groups and cohorts

  • NERD

    patients with typical gastro-reflux symptoms but no erosions were discernible on upper gastrointestinal endoscopy

    Other: Anthropometric measurements

  • EE

    Patients with both typical gastroesophageal reflux symptoms and characteristic flam-like erosions as demonstrated on upper gastrointestinal endoscopy

    Other: Anthropometric measurements

  • FD

    Patients report no typical reflux symptoms but fulfill diagnostic criteria of functional dyspepsia, whose upper gastrointestinal endoscopy are negative.

    Other: Anthropometric measurements

Interventions

  • OtherAnthropometric measurements

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

06

What researchers measure

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)

07

Study locations

1 site
  • Lotung Poh-Ai Hospital
    Lotung Town, Ilan County, 265, Taiwan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 19, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00698178
Lead sponsor
Lotung Poh-Ai Hospital
First posted
Jun 17, 2008
Start date
Jun 2008
Primary completion
Jul 2009
Completion
Aug 2009
Last update
Oct 19, 2010

Study contacts

Yao-Chun Hsu, M.D.
principal investigator · Lotung Poh-Ai Hospital, Ilan, Taiwan

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2010. You cannot join it, but the record below documents what was studied.

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