Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2026-02-08 @ 6:44 PM
Study NCT ID:
NCT02688920
Status:
COMPLETED
Last Update Posted:
2019-03-08
First Post:
2016-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intraluminal Imaging of Duodenal Layer Morphometry in Patients With and Without Type 2 Diabetes
Sponsor:
Victoria Gomez
Organization:
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: