Gastroesophageal Reflux Disease (GERD) Clinical Trial
Official title:
The Role of Anthropometry in Gastroesophageal Reflux Disease and Esophageal Injury
Verified date | March 2014 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
Is waist to hip ratio (WHR), waist circumference (WC), (as markers of visceral adiposity) associated with an increase in acidic and non acidic reflux as well as systemic inflammation involving esophageal mucosa, thereby increasing esophageal injury and predisposing to subsequent development of Barrett's esophagus (BE)?
Status | Completed |
Enrollment | 100 |
Est. completion date | December 2012 |
Est. primary completion date | November 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion: - Subjects over the age of 18 undergoing clinically indicated 24 hour pH impedance and/or pH studies. Many will also undergo clinically indicated endoscopy, and consent for acquiring tissue samples for future biomarker staining tests will be obtained. - Able to give informed consent Exclusion: - Subjects with a prior history of esophageal surgery, or diagnosis of BE. |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Correlate Anthropometry with number of acid reflux episodes | To correlate measures of central obesity waist/hip ratio (WHR) and waist circumference (WC) with number of reflux episodes (acidic and non acidic), and other measures of acid/non acid reflux. Stratify by use of proton pump inhibitors (PPIs). | 1 year | No |
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