Intraluminal Imaging of Duodenal Layer Morphometry in Patients With and Without Type 2 Diabetes



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:3/10/2019
Start Date:March 2016
End Date:February 2019

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A Single-center, Observational, Intraluminal Imaging Study of Duodenal Layer Morphometry in Patients With and Without Type 2 Diabetes Undergoing Endoscopy of the Upper Gastrointestinal Tract

This observational study is conducted to determine how the duodenal layer thicknesses
(mucosa, submucosa, and muscularis) vary with several factors in patients with and without
type 2 diabetes.

Study Objectives

1. To assess duodenal layer (mucosa, submucosa and muscularis) thickness differences
between patients with and without type 2 diabetes using endoscopic ultrasound (EUS) and
optical coherence tomography (OCT).

2. To assess duodenal layer thickness differences between patients with type 2 diabetes.

3. To assess duodenal layer thickness differences as a function of measurement location
along the length of the duodenum.

4. To compare measurements obtained by endoscopic ultrasound, to those obtained by optical
coherence tomography.

Inclusion Criteria:

- Patient is already scheduled for upper endoscopy with ultrasound or OCT, such as those
with Barrett's esophagus.

- Patient is willing to sign an informed consent form.

Exclusion Criteria:

- Patient is not a candidate for endoscopy, EUS, or OCT, such as those with strictures,
inflammatory disease or previous anastomosis of the esophagus or duodenum.
We found this trial at
1
site
4500 San Pablo Rd S
Jacksonville, Florida 32224
(904) 953-2000
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