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

NCT00698178 | Completed DMC

• 1 other identifier: OMCP-97-009
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroesophageal Reflux Disease; Obesity

Keywords

Gastroesophageal reflux disease; Waist circumference; Body mass index; Obesity

Outcome Measures

Primary Outcomes (1)

• the degree fo erosive esophagitis according to Los-Angels classification

  on the day of endoscopy examination

Secondary Outcomes (1)

• gastro-reflux severity score as evaluated by standardized questionnaire

  at enrollment (before upper GI endoscopy)

Study Arms (3)

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

Anthropometric measurements OTHER

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

EE; FD; NERD

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lotung Poh-Ai Hospital: lead

Study Sites (1)

Lotung Poh-Ai Hospital

Lotung Town, Ilan County, 265, Taiwan

Location

MeSH Terms

Conditions

Gastroesophageal Reflux; Obesity

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yao-Chun Hsu, M.D.

  Lotung Poh-Ai Hospital, Ilan, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 13, 2008
• First Posted: June 17, 2008
• Study Start: June 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: August 1, 2009
• Last Updated: October 19, 2010

Record last verified: 2010-10

Locations

TW (1)