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

Completed

• Conditions: Gastroesophageal Reflux Disease; Obesity
• Interventions: Other: Anthropometric measurements

• Registration Number: NCT00698178
• Lead Sponsor: Lotung Poh-Ai Hospital

Brief 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.

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.

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-13
• Study First Submitted QC: 2008-06-16
• Study First Posted: 2008-06-17
• Primary Completion: 2009-07
• Study Completion: 2009-08
• Status Verified: 2010-10
• Last Update Submitted: 2010-10-18
• Last Update Posted: 2010-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
the degree fo erosive esophagitis according to Los-Angels classification	on the day of endoscopy examination

Secondary Outcome Measures

Name	Time	Method
gastro-reflux severity score as evaluated by standardized questionnaire	at enrollment (before upper GI endoscopy)

Trial Locations

Locations (1)

Lotung Poh-Ai Hospital; 🇨🇳 Lotung Town, Ilan County, Taiwan