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.

Study Overview

• Status: Completed
• Conditions: Obesity; Gastroesophageal Reflux Disease
• Intervention / Treatment: Other: Anthropometric measurements

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 Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
NERD; patients with typical gastro-reflux symptoms but no erosions were discernible on upper gastrointestinal endoscopy	Other: Anthropometric measurements; All patients undergo anthropometric measurements to record body weight, body height and waist circumference on the day of enrollment
EE; Patients with both typical gastroesophageal reflux symptoms and characteristic flam-like erosions as demonstrated on upper gastrointestinal endoscopy	Other: Anthropometric measurements; All patients undergo anthropometric measurements to record body weight, body height and waist circumference on the day of enrollment
FD; Patients report no typical reflux symptoms but fulfill diagnostic criteria of functional dyspepsia, whose upper gastrointestinal endoscopy are negative.	Other: Anthropometric measurements; All patients undergo anthropometric measurements to record body weight, body height and waist circumference on the day of enrollment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the degree fo erosive esophagitis according to Los-Angels classification	on the day of endoscopy examination

Secondary Outcome Measures

Outcome Measure	Time Frame
gastro-reflux severity score as evaluated by standardized questionnaire	at enrollment (before upper GI endoscopy)

Collaborators and Investigators

• Sponsor: Lotung Poh-Ai Hospital
• Investigators: Principal Investigator: Yao-Chun Hsu, M.D., Lotung Poh-Ai Hospital, Ilan, Taiwan

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (ACTUAL): July 1, 2009
• Study Completion (ACTUAL): August 1, 2009

Study Registration Dates

• First Submitted: June 13, 2008
• First Submitted That Met QC Criteria: June 16, 2008
• First Posted (ESTIMATE): June 17, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): October 19, 2010
• Last Update Submitted That Met QC Criteria: October 18, 2010
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Keywords: Obesity; Gastroesophageal reflux disease; Body mass index; Waist circumference
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Intestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Esophagitis; Peptic Ulcer; Duodenal Diseases; Gastroesophageal Reflux; Esophagitis, Peptic
• Other Study ID Numbers: OMCP-97-009