Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT05076812
Status:
UNKNOWN
Last Update Posted:
2021-10-21
First Post:
2021-09-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Interleukin 38 as a Biomarker for Metabolic Syndrome in Psoriatic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-13', 'studyFirstSubmitDate': '2021-09-20', 'studyFirstSubmitQcDate': '2021-09-29', 'lastUpdatePostDateStruct': {'date': '2021-10-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'measure plasma level of interleukin 38 in all groups', 'timeFrame': 'through study completion an average of 18 months', 'description': 'level of interleukin 38 will be measured and compared in all groups to asses the relationship between this interleukin and metabolic syndrome in psoriatic patients'}]}, 'oversightModule': {'isFdaRegulatedDrug': False}, 'conditionsModule': {'keywords': ['psoriasis', 'metabolic syndrome', 'interleukin 38'], 'conditions': ['Psoriasis']}, 'descriptionModule': {'briefSummary': 'case control study to compare level of interleukin 38 in patients with psoriasis and patients with metabolic syndrome with healthy control subjects', 'detailedDescription': 'this case control study will measure plasma level of interleukin 38 in 4 groups of 24 subject, group one will have psoriatic patients, group 2 will have psoriatic patients with metabolic syndrome, group three will have patients with metabolic syndrome only, and group 4 will have healthy control subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'people attending the Dermatology Outpatient Clinics of Sohag University Hospital.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* specific to each group\n\nExclusion Criteria:\n\n* Patient refusal. Age \\<18 years Pregnancy Lactation smoking Infections. Patients with other inflammatory skin disorders use of antioxidant and anti-inflammatory drugs patients on treatment for psoriasis'}, 'identificationModule': {'nctId': 'NCT05076812', 'briefTitle': 'Interleukin 38 as a Biomarker for Metabolic Syndrome in Psoriatic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Interleukin 38 as a Biomarker for Metabolic Syndrome in Psoriatic Patients', 'orgStudyIdInfo': {'id': 'Soh-Med-21-09-02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1 (Psoriasis only)', 'description': 'contains 24 psoriatic patients, Psoriasis Area Severity Index will be measured, also waist circumference, body mass index, blood pressure, fasting blood glucose and fasting lipid profile and finally: plasma level of interleukin 38', 'interventionNames': ['Diagnostic Test: measure plasma level of interleukin 38 by ELISA kit']}, {'label': 'Group 2 (Psoriasis and metabolic syndrome)', 'description': 'contains 24 psoriatic patients with metabolic syndrome. Psoriasis Area Severity Index will be measured metabolic syndrome is diagnosed after measuring waist circumference, body mass index, blood pressure, fasting blood glucose and fasting lipid profile finally: plasma level of interleukin 38', 'interventionNames': ['Diagnostic Test: measure plasma level of interleukin 38 by ELISA kit']}, {'label': 'Group 3 (Metabolic syndrome only)', 'description': 'contains 24 patients with metabolic syndrome only. full dermatological examination to exclude psoriasis and other inflammatory skin disorders metabolic syndrome is diagnosed after measuring waist circumference, body mass index, blood pressure, fasting blood glucose and fasting lipid profile finally: plasma level of interleukin 38', 'interventionNames': ['Diagnostic Test: measure plasma level of interleukin 38 by ELISA kit']}, {'label': 'Group 4 (Healthy Controls)', 'description': 'contains 24 healthy control subjects full dermatological examination to exclude psoriasis and other inflammatory skin disorders metabolic syndrome is excluded after measuring waist circumference, body mass index, blood pressure, fasting blood glucose and fasting lipid profile finally: plasma level of interleukin 38', 'interventionNames': ['Diagnostic Test: measure plasma level of interleukin 38 by ELISA kit']}], 'interventions': [{'name': 'measure plasma level of interleukin 38 by ELISA kit', 'type': 'DIAGNOSTIC_TEST', 'description': 'draw 5 ml of venous blood into EDTA tubes and centrifuged then plasma is separated for test', 'armGroupLabels': ['Group 1 (Psoriasis only)', 'Group 2 (Psoriasis and metabolic syndrome)', 'Group 3 (Metabolic syndrome only)', 'Group 4 (Healthy Controls)']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yomna A Abdellatif, MBBCH', 'role': 'CONTACT', 'email': 'yomna.a.abdellatif@gmail.com', 'phone': '01119200320', 'phoneExt': '+2'}, {'name': 'wafaa m abdel-magid, asst prof', 'role': 'CONTACT', 'phone': '0 100 8813349', 'phoneExt': '+2'}], 'overallOfficials': [{'name': 'yomna a abdellatif, MBBCH', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident doctor in dermatology venereology and andrology department in sohag university hospital', 'investigatorFullName': 'Yomna Abdo Abdellatif', 'investigatorAffiliation': 'Sohag University'}}}}