Trials / Completed
CompletedNCT01570842
Anthropometry in Gastroesophageal Reflux Disease and Esophageal Injury
The Role of Anthropometry in Gastroesophageal Reflux Disease and Esophageal Injury
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 100 (actual)
- Sponsor
- Mayo Clinic · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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)?
Detailed description
The investigators will study 100 adult subjects over the age of 18 from the esophageal motility lab who are undergoing clinically indicated 24 hour acidity or basicity (pH) impedance and/or pH studies off acid suppressing medication.. These subjects will not have a prior history of esophageal surgery, or diagnosis of BE. The investigators will obtain consent for taking anthropometric measurements (Waist and hip circumference), and the results of their study. Only those subjects that successfully complete the 24 hour pH impedance studies will be included. Subjects will also undergo clinically indicated endoscopy. The investigators will consent these subjects to obtain 4 biopsies (bx) from the gastroesophageal (GE) junction and 4 bx from 5 cm above the GE junction. These bio-specimens will be stored for assessment of tissue injury (PGE2) and tissue immune-histochemistry of BE precursors (CDX1 and CDX2) at a later date.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Anthropometric measurements | All participants will have their waist circumference and waist to hip ratio taken as a measurement of central obesity. |
| PROCEDURE | Tissue samples | Participants undergoing clinically indicated upper endoscopy and who consent to providing tissue samples will have 8 tissue samples taken for future research purposes. |
Timeline
- Start date
- 2011-10-01
- Primary completion
- 2012-11-01
- Completion
- 2012-12-01
- First posted
- 2012-04-04
- Last updated
- 2014-03-31
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01570842. Inclusion in this directory is not an endorsement.