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

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02688920
• Other study ID #: 15-007742
• Status: Completed
• Start date: March 2016
• Est. completion date: February 2019

Study information

• Verified date: March 2019
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: February 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Procedure:
• EUS and OCT imaging
Intraluminal imaging using endoscopic ultrasound and endoscopic optical coherence tomography

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Victoria Gomez

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Rösch T, Lorenz R, Zenker K, von Wichert A, Dancygier H, Höfler 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Thickness of the duodenal muscularis using OCT if possible, and EUS		During imaging
Primary	Thickness of the duodenal mucosa using OCT, and EUS if possible		During imaging
Secondary	Thickness of the duodenal submucosa using OCT if possible, and EUS		During imaging

External Links

•   Mayo Clinic Clinical Trials