Skip to content

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

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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02688920
Enrollment
21
Registered
2016-02-23
Start date
2016-03-31
Completion date
2019-02-28
Last updated
2019-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

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.

Interventions

PROCEDUREEUS and OCT imaging

Intraluminal imaging using endoscopic ultrasound and endoscopic optical coherence tomography

Sponsors

Victoria Gomez
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Thickness of the duodenal mucosa using OCT, and EUS if possibleDuring imaging

Secondary

MeasureTime frame
Thickness of the duodenal submucosa using OCT if possible, and EUSDuring imaging

Other

MeasureTime frame
Thickness of the duodenal muscularis using OCT if possible, and EUSDuring imaging

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026