Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2026-01-02 @ 7:19 AM
Study NCT ID:
NCT05596656
Status:
COMPLETED
Last Update Posted:
2022-10-28
First Post:
2022-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IgE-mediated Allergies Among Type 1 Diabetes Mellitus Children, Single Centre Observational Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010328', 'term': 'Patch Tests'}], 'ancestors': [{'id': 'D012882', 'term': 'Skin Tests'}, {'id': 'D007159', 'term': 'Immunologic Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2019-12-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-26', 'studyFirstSubmitDate': '2022-10-24', 'studyFirstSubmitQcDate': '2022-10-26', 'lastUpdatePostDateStruct': {'date': '2022-10-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'positive skin prick test', 'timeFrame': '20 minutes', 'description': 'a wheal ≥3 mm diameter more than negative control for detection of specific IgE to one or more of common aeroallergens.'}]}, 'conditionsModule': {'conditions': ['Diabetic Children']}, 'referencesModule': {'references': [{'pmid': '23369181', 'type': 'BACKGROUND', 'citation': 'Heinzerling L, Mari A, Bergmann KC, Bresciani M, Burbach G, Darsow U, Durham S, Fokkens W, Gjomarkaj M, Haahtela T, Bom AT, Wohrl S, Maibach H, Lockey R. The skin prick test - European standards. Clin Transl Allergy. 2013 Feb 1;3(1):3. doi: 10.1186/2045-7022-3-3.'}]}, 'descriptionModule': {'briefSummary': 'an interviewer-administrated questionnaire was designed to take history of allergy in diabetic child come to outpatient clinic fulfilling inclusion criteria and used to collect data. Skin prick testing was performed to all diabetic children with history of allergy. Laboratory assessment of Serum Total IgE, IL5 and eosinophils%.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '2 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Children with at least 2 years' duration of Type 1 Diabetes Mellitus. Participants: among 200 cases with Type 1 DM children following up at endocrinology unit", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children with at least 2 Years duration of diabetes diagnosed by Criteria for the diagnosis of diabetes mellitus (ISPAD 2018) that include:\n* Classic symptoms of diabetes or hyperglycemic crisis, with plasma glucose concentration ≥11.1 mmol/L (200 mg/dL).\n* Fasting plasma glucose ≥7.0 mmol/L (≥126 mg/dL). Fasting is defined as no caloric intake for at least 8 hours.\n* Two-hour post load glucose ≥11.1 mmol/L (≥200 mg/dL) during an oral glucose tolerance test (OGTT).\n* HbA1c ≥6.5%.\n\nExclusion Criteria:\n\n* presence of other chronic disease associated with DM.'}, 'identificationModule': {'nctId': 'NCT05596656', 'briefTitle': 'IgE-mediated Allergies Among Type 1 Diabetes Mellitus Children, Single Centre Observational Study', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University Children Hospital'}, 'officialTitle': 'IgE-mediated Allergies Among Type 1 Diabetes Mellitus Children, Single Centre Observational Study', 'orgStudyIdInfo': {'id': 'MS/17.07.21'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'allergic type 1 DM children', 'description': '45 cases were considered allergic based on written questionnaire taken by the resident. Diagnosis of atopy was confirmed by skin prick testing', 'interventionNames': ['Diagnostic Test: skin prick test']}, {'label': 'Non-allergic type 1 DM children', 'description': 'Forty-five Non-allergic type 1 DM children were selected as age and sex matched control group.', 'interventionNames': ['Diagnostic Test: skin prick test']}], 'interventions': [{'name': 'skin prick test', 'type': 'DIAGNOSTIC_TEST', 'description': 'Skin prick testing was performed to all diabetic child with history of allergy. The recommended method of prick testing includes the appropriate use of specific allergen extracts, positive and negative controls, interpretation of the tests after 15 - 20 minutes of application, with a positive result defined as a wheal ≥3 mm diameter more than negative control for detection of specific IgE to one or more of common aeroallergens.\n\nThe location of each allergen was marked with a pen on the volar aspect of forearm to properly identify test results, at least 2 cm from the wrist and the antecubital fossae. The distance between two skin prick tests should be appropriate to avoid false-positive reactions due to direct contamination of a nearby test. A drop of each test solution should be placed on the skin in identical order for each subject tested and immediately pricked with a single-head metal lancet.', 'armGroupLabels': ['Non-allergic type 1 DM children', 'allergic type 1 DM children']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35516', 'city': 'Al Mansurah', 'state': 'None Selected', 'country': 'Egypt', 'facility': 'Mansoura University Children Hospital', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'overallOfficials': [{'name': 'Engy Osman, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'assistant Professor, Pediatrics Department, Faculty of Medicine, Mansoura University, Egypt.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University Children Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor', 'investigatorFullName': 'Engy Osman Ahmed', 'investigatorAffiliation': 'Mansoura University Children Hospital'}}}}