Gastroesophageal Reflux DiseaseNCT00698178
Waist Circumference Versus Body Mass Index to Predict Severity of Gastroesophageal Reflux Disease
An observational study of Gastroesophageal Reflux Disease and Obesity, run by Lotung Poh-Ai Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Gastroesophageal Reflux Disease, Obesity
- What is being tested?
- Anthropometric measurements
- How many people
- 500 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2008to Aug 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatients at a general hospital with 1000 beds in north-eastern Taiwan
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Gastroesophageal Reflux Disease, Obesity
- Being tested
- Anthropometric measurements
- Keywords
- Gastroesophageal reflux disease, Waist circumference, Body mass index, Obesity
- Medical subject headings
- Gastroesophageal Reflux, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anthropometric measurementsOther
All patients undergo anthropometric measurements to record body weight, body height and waist circumference on the day of enrollment
| Study group | Role | What they receive |
|---|---|---|
| NERD | patients with typical gastro-reflux symptoms but no erosions were discernible on upper gastrointestinal endoscopy Receives: Other: Anthropometric measurements | |
| EE | Patients with both typical gastroesophageal reflux symptoms and characteristic flam-like erosions as demonstrated on upper gastrointestinal endoscopy Receives: Other: Anthropometric measurements | |
| FD | Patients report no typical reflux symptoms but fulfill diagnostic criteria of functional dyspepsia, whose upper gastrointestinal endoscopy are negative. Receives: Other: Anthropometric measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
the degree fo erosive esophagitis according to Los-Angels classification
Measured: on the day of endoscopy examination
Secondary outcomes (1)
gastro-reflux severity score as evaluated by standardized questionnaire
Measured: at enrollment (before upper GI endoscopy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionJul 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lotung Poh-Ai Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Yao-Chun Hsu, M.D., Principal investigator, Lotung Poh-Ai Hospital, Ilan, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00698178
- Sponsor's protocol ID
- OMCP-97-009
- Status last verified
- Oct 2010
- First submitted
- 13 Jun 2008
- Last updated
- 19 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Waist Circumference Versus Body Mass Index to Predict Severity of Gastroesophageal Reflux Disease
- ClinicalTrials.gov ID
- NCT00698178
- Acronym / sponsor ID
- OMCP-97-009
- Conditions
- Gastroesophageal Reflux Disease, Obesity
- Keywords
- Gastroesophageal reflux disease, Waist circumference, Body mass index, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Lotung Poh-Ai HospitalUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 17 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NERD | – | Other: Anthropometric measurementspatients with typical gastro-reflux symptoms but no erosions were discernible on upper gastrointestinal endoscopy |
| EE | – | Other: Anthropometric measurementsPatients with both typical gastroesophageal reflux symptoms and characteristic flam-like erosions as demonstrated on upper gastrointestinal endoscopy |
| FD | – | Other: Anthropometric measurementsPatients report no typical reflux symptoms but fulfill diagnostic criteria of functional dyspepsia, whose upper gastrointestinal endoscopy are negative. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients at a general hospital with 1000 beds in north-eastern Taiwan
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anthropometric measurementsAll patients undergo anthropometric measurements to record body weight, body height and waist circumference on the day of enrollment | Other | EE, FD, NERD |
Primary outcome
the degree fo erosive esophagitis according to Los-Angels classification
Time frame: on the day of endoscopy examination
1 secondary outcome
gastro-reflux severity score as evaluated by standardized questionnaire
Time frame: at enrollment (before upper GI endoscopy)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yao-Chun Hsu, M.D. principal investigator
Lotung Poh-Ai Hospital, Ilan, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroesophageal Reflux Disease and Obesity, run by Lotung Poh-Ai Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the degree fo erosive esophagitis according to Los-Angels classification (time frame: on the day of endoscopy examination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2010.