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

L

Lotung Poh-Ai Hospital

Status

Completed

Conditions

Gastroesophageal Reflux Disease
Obesity

Treatments

Other: Anthropometric measurements

Study type

Observational

Funder types

Other

Identifiers

NCT00698178
OMCP-97-009

Details and patient eligibility

About

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.

Full 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.

Enrollment

500 estimated patients

Sex

All

Ages

20 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

500 participants in 3 patient groups

NERD
Description:
patients with typical gastro-reflux symptoms but no erosions were discernible on upper gastrointestinal endoscopy
Treatment:
Other: Anthropometric measurements
EE
Description:
Patients with both typical gastroesophageal reflux symptoms and characteristic flam-like erosions as demonstrated on upper gastrointestinal endoscopy
Treatment:
Other: Anthropometric measurements
FD
Description:
Patients report no typical reflux symptoms but fulfill diagnostic criteria of functional dyspepsia, whose upper gastrointestinal endoscopy are negative.
Treatment:
Other: Anthropometric measurements

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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