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Completed

NCT Number: NCT02688920

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EUS and OCT imaging

Procedure

Intraluminal imaging using endoscopic ultrasound and endoscopic optical coherence tomography

Primary outcomes

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

    Time frame: During imaging

Secondary outcomes

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

    Time frame: During imaging

Other outcomes

  1. Thickness of the duodenal muscularis using OCT if possible, and EUS

    Time frame: During imaging

Sponsors and collaborators

Lead sponsor

Victoria Gomez

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Feb 23, 2016
Registry last updated
Mar 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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