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

V

Victoria Gomez

Status

Completed

Conditions

Type 2 Diabetes

Treatments

Procedure: EUS and OCT imaging

Study type

Observational

Funder types

Other

Identifiers

NCT02688920
15-007742

Details and patient eligibility

About

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.

Full description

Study Objectives 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). To assess duodenal layer thickness differences between patients with type 2 diabetes. To assess duodenal layer thickness differences as a function of measurement location along the length of the duodenum. To compare measurements obtained by endoscopic ultrasound, to those obtained by optical coherence tomography.

Enrollment

21 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

21 participants in 2 patient groups

With T2DM
Description:
Subjects with type 2 diabetes.
Treatment:
Procedure: EUS and OCT imaging
Without T2DM
Description:
Subjects without type 2 diabetes
Treatment:
Procedure: EUS and OCT imaging

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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