Intraluminal Imaging of Duodenal Layer Morphometry in Patients With and Without Type 2 Diabetes
NCT ID: NCT02688920
Last Updated: 2019-03-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
21 participants
OBSERVATIONAL
2016-03-31
2019-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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With T2DM
Subjects with type 2 diabetes.
EUS and OCT imaging
Intraluminal imaging using endoscopic ultrasound and endoscopic optical coherence tomography
Without T2DM
Subjects without type 2 diabetes
EUS and OCT imaging
Intraluminal imaging using endoscopic ultrasound and endoscopic optical coherence tomography
Interventions
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EUS and OCT imaging
Intraluminal imaging using endoscopic ultrasound and endoscopic optical coherence tomography
Eligibility Criteria
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Inclusion Criteria
* Patient is willing to sign an informed consent form.
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Victoria Gomez
OTHER
Responsible Party
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Victoria Gomez
Gastroenterologist
Principal Investigators
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Victoria Gomez, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Florida
Jacksonville, Florida, United States
Countries
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References
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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.
Other Identifiers
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15-007742
Identifier Type: -
Identifier Source: org_study_id
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