Clinical trial NCT02688920: Intraluminal Imaging of Duodenal Layer Morphometry in Patients With and Without Type 2 Diabetes
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2016-02-23
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing previously scheduled routine endoscopy of the upper gastrointestinal tract.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Thickness of the duodenal mucosa using OCT, and EUS if possible
timeFrame: During imaging
Secondary outcomes:
measure: Thickness of the duodenal submucosa using OCT if possible, and EUS
timeFrame: During imaging
Other outcomes:
measure: Thickness of the duodenal muscularis using OCT if possible, and EUS
timeFrame: During imaging
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Victoria Gomez, MD
role: PRINCIPAL_INVESTIGATOR
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