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

Victoria Gomez21 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Type 2 Diabetes

Interventions

EUS and OCT imagingPROCEDURE

Intraluminal imaging using endoscopic ultrasound and endoscopic optical coherence tomography

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Mayo Clinic in Florida

Jacksonville, Florida, United States

Outcomes

Primary Outcomes

Thickness of the duodenal mucosa using OCT, and EUS if possible

Time frame: During imaging

Secondary Outcomes

Thickness of the duodenal submucosa using OCT if possible, and EUS

Time frame: During imaging

Data from ClinicalTrials.gov

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