Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2026-04-16 @ 6:25 PM
Study NCT ID:
NCT02688920
Status:
COMPLETED
Last Update Posted:
2019-03-08
First Post:
2016-02-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intraluminal Imaging of Duodenal Layer Morphometry in Patients With and Without Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-06', 'studyFirstSubmitDate': '2016-02-18', 'studyFirstSubmitQcDate': '2016-02-22', 'lastUpdatePostDateStruct': {'date': '2019-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Thickness of the duodenal muscularis using OCT if possible, and EUS', 'timeFrame': 'During imaging'}], 'primaryOutcomes': [{'measure': 'Thickness of the duodenal mucosa using OCT, and EUS if possible', 'timeFrame': 'During imaging'}], 'secondaryOutcomes': [{'measure': 'Thickness of the duodenal submucosa using OCT if possible, and EUS', 'timeFrame': 'During imaging'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '19272486', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '24603700', 'type': 'BACKGROUND', '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.'}, {'pmid': '2028847', 'type': 'BACKGROUND', '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. doi: 10.1093/ageing/20.1.29.'}, {'pmid': '6737178', 'type': 'BACKGROUND', '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. doi: 10.1097/00005176-198406000-00008."}, {'pmid': '1511822', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '7859967', 'type': 'BACKGROUND', '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.'}, {'pmid': '10744825', 'type': 'BACKGROUND', '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. doi: 10.1016/s0016-5107(00)70450-0.'}, {'pmid': '20585935', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Study Objectives\n\n1. 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).\n2. To assess duodenal layer thickness differences between patients with type 2 diabetes.\n3. To assess duodenal layer thickness differences as a function of measurement location along the length of the duodenum.\n4. To compare measurements obtained by endoscopic ultrasound, to those obtained by optical coherence tomography.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing previously scheduled routine endoscopy of the upper gastrointestinal tract.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient is already scheduled for upper endoscopy with ultrasound or OCT, such as those with Barrett's esophagus.\n* Patient is willing to sign an informed consent form.\n\nExclusion Criteria:\n\n* 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."}, 'identificationModule': {'nctId': 'NCT02688920', 'briefTitle': 'Intraluminal Imaging of Duodenal Layer Morphometry in Patients With and Without Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '15-007742'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'With T2DM', 'description': 'Subjects with type 2 diabetes.', 'interventionNames': ['Procedure: EUS and OCT imaging']}, {'label': 'Without T2DM', 'description': 'Subjects without type 2 diabetes', 'interventionNames': ['Procedure: EUS and OCT imaging']}], 'interventions': [{'name': 'EUS and OCT imaging', 'type': 'PROCEDURE', 'description': 'Intraluminal imaging using endoscopic ultrasound and endoscopic optical coherence tomography', 'armGroupLabels': ['With T2DM', 'Without T2DM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic in Florida', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}], 'overallOfficials': [{'name': 'Victoria Gomez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Victoria Gomez', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Gastroenterologist', 'investigatorFullName': 'Victoria Gomez', 'investigatorAffiliation': 'Mayo Clinic'}}}}