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

Completed

• Conditions: Type 2 Diabetes
• Interventions: Procedure: EUS and OCT imaging

• Registration Number: NCT02688920
• Lead Sponsor: Victoria Gomez

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2016-02-18
• Study First Submitted QC: 2016-02-22
• Study First Posted: 2016-02-23
• Study Start: 2016-03
• Primary Completion: 2019-02
• Study Completion: 2019-02
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-06
• Last Update Posted: 2019-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
With T2DM	EUS and OCT imaging	Subjects with type 2 diabetes.
Without T2DM	EUS and OCT imaging	Subjects without type 2 diabetes

Primary Outcome Measures

Name	Time	Method
Thickness of the duodenal mucosa using OCT, and EUS if possible	During imaging

Secondary Outcome Measures

Name	Time	Method
Thickness of the duodenal submucosa using OCT if possible, and EUS	During imaging

Trial Locations

Locations (1)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States