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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Procedure: EUS and OCT imaging

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.

• Study Type: Observational
• Enrollment (Actual): 21

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic in Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients undergoing previously scheduled routine endoscopy of the upper gastrointestinal tract.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
With T2DM; Subjects with type 2 diabetes.	Procedure: EUS and OCT imaging; Intraluminal imaging using endoscopic ultrasound and endoscopic optical coherence tomography
Without T2DM; Subjects without type 2 diabetes	Procedure: EUS and OCT imaging; Intraluminal imaging using endoscopic ultrasound and endoscopic optical coherence tomography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Thickness of the duodenal mucosa using OCT, and EUS if possible	During imaging

Secondary Outcome Measures

Outcome Measure	Time Frame
Thickness of the duodenal submucosa using OCT if possible, and EUS	During imaging

Other Outcome Measures

Outcome Measure	Time Frame
Thickness of the duodenal muscularis using OCT if possible, and EUS	During imaging

Collaborators and Investigators

• Sponsor: Victoria Gomez
• Investigators: Principal Investigator: Victoria Gomez, MD, Mayo Clinic

Publications and helpful links

General Publications

• Buchwald H, Estok R, Fahrbach K, Banel D, Jensen MD, Pories WJ, Bantle JP, Sledge I. Weight and type 2 diabetes after bariatric surgery: systematic review and meta-analysis. Am J Med. 2009 Mar;122(3):248-256.e5. doi: 10.1016/j.amjmed.2008.09.041.
• Nagatake T, Fujita H, Minato N, Hamazaki Y. Enteroendocrine cells are specifically marked by cell surface expression of claudin-4 in mouse small intestine. PLoS One. 2014 Mar 6;9(6):e90638. doi: 10.1371/journal.pone.0090638. eCollection 2014.
• Haboubi NY, Lee GS, Montgomery RD. Duodenal mucosal morphometry of elderly patients with small intestinal bacterial overgrowth: response to antibiotic treatment. Age Ageing. 1991 Jan;20(1):29-32. doi: 10.1093/ageing/20.1.29.
• Maluenda C, Phillips AD, Briddon A, Walker-Smith JA. Quantitative analysis of small intestinal mucosa in cow's milk-sensitive enteropathy. J Pediatr Gastroenterol Nutr. 1984 Jun;3(3):349-56. doi: 10.1097/00005176-198406000-00008.
• Rosch T, Lorenz R, Zenker K, von Wichert A, Dancygier H, Hofler H, Siewert JR, Classen M. Local staging and assessment of resectability in carcinoma of the esophagus, stomach, and duodenum by endoscopic ultrasonography. Gastrointest Endosc. 1992 Jul-Aug;38(4):460-7. doi: 10.1016/s0016-5107(92)70477-5.
• Chang KJ, Katz KD, Durbin TE, Erickson RA, Butler JA, Lin F, Wuerker RB. Endoscopic ultrasound-guided fine-needle aspiration. Gastrointest Endosc. 1994 Nov-Dec;40(6):694-9.
• Sivak MV Jr, Kobayashi K, Izatt JA, Rollins AM, Ung-Runyawee R, Chak A, Wong RC, Isenberg GA, Willis J. High-resolution endoscopic imaging of the GI tract using optical coherence tomography. Gastrointest Endosc. 2000 Apr;51(4 Pt 1):474-9. doi: 10.1016/s0016-5107(00)70450-0.
• Gniuli D, Calcagno A, Dalla Libera L, Calvani R, Leccesi L, Caristo ME, Vettor R, Castagneto M, Ghirlanda G, Mingrone G. High-fat feeding stimulates endocrine, glucose-dependent insulinotropic polypeptide (GIP)-expressing cell hyperplasia in the duodenum of Wistar rats. Diabetologia. 2010 Oct;53(10):2233-40. doi: 10.1007/s00125-010-1830-9. Epub 2010 Jun 30.

Helpful Links

• Mayo Clinic Clinical Trials
• Centers for Disease Control and Prevention. National Diabetes Statistics Report: Estimates of Diabetes and Its Burden in the United States, 2014. Atlanta, GA: U.S. Department of Health and Human Services; 2014.

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): February 1, 2019
• Study Completion (Actual): February 1, 2019

Study Registration Dates

• First Submitted: February 18, 2016
• First Submitted That Met QC Criteria: February 22, 2016
• First Posted (Estimate): February 23, 2016

Study Record Updates

• Last Update Posted (Actual): March 8, 2019
• Last Update Submitted That Met QC Criteria: March 6, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 15-007742

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No