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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00698178
• Other study ID #: OMCP-97-009
• Status: Completed
• Phase: N/A
• First received: June 13, 2008
• Last updated: October 18, 2010
• Start date: June 2008
• Est. completion date: August 2009

Study information

• Verified date: October 2010
• Source: Lotung Poh-Ai Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: August 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease
• Obesity

Intervention

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

Locations

Country	Name	City	State
Taiwan	Lotung Poh-Ai Hospital	Lotung Town, Ilan County

Sponsors (1)

Lead Sponsor	Collaborator
Lotung Poh-Ai Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the degree fo erosive esophagitis according to Los-Angels classification		on the day of endoscopy examination	No
Secondary	gastro-reflux severity score as evaluated by standardized questionnaire		at enrollment (before upper GI endoscopy)	No