Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-03-02 @ 8:03 PM
Study NCT ID:
NCT03622320
Status:
COMPLETED
Last Update Posted:
2025-04-24
First Post:
2018-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metabolic Syndrome in Early Onset Versus Late Onset Vitiligo
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D014820', 'term': 'Vitiligo'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D017496', 'term': 'Hypopigmentation'}, {'id': 'D010859', 'term': 'Pigmentation Disorders'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-22', 'studyFirstSubmitDate': '2018-07-16', 'studyFirstSubmitQcDate': '2018-08-07', 'lastUpdatePostDateStruct': {'date': '2025-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Central obesity as a Metabolic risk in vitiligo patients', 'timeFrame': 'one year', 'description': 'Central obesity will be assessed using waist circumference in cm in vitiligo patients and control group as a risk factor for metabolic syndrome'}], 'secondaryOutcomes': [{'measure': 'Arterial Blood Pressure as a Metabolic risk in vitiligo patients', 'timeFrame': 'one year', 'description': 'Arterial Blood Pressure will be assessed in vitiligo patients and control group as a risk factor for metabolic syndrome'}, {'measure': 'Fasting Blood pressure as a Metabolic risk in vitiligo patients', 'timeFrame': 'one year', 'description': 'Fasting Blood pressure will be assessed in vitiligo patients and control group as a risk factor for metabolic syndrome'}, {'measure': 'Serum Triglycerides and HDL', 'timeFrame': 'one year', 'description': 'Serum Triglycerides and HDL will be assessed in vitiligo patients and control group as a risk factor for metabolic syndrome'}, {'measure': 'Body mass index as a Metabolic risk in vitiligo patients', 'timeFrame': 'one year', 'description': 'Body Mass index in kg/m2 will be assessed in vitiligo patients and control group as a risk factor for metabolic syndrome'}, {'measure': 'Detection of insulin resistance in patients with vitiligo', 'timeFrame': 'one year', 'description': 'This is via measuring HOMA-IR'}, {'measure': 'Correlation between extent/ severity/duration/ activity of vitiligo and possible associated metabolic derangements.', 'timeFrame': 'one year', 'description': 'This via detecting VASI, VES and VIDA scores for vitiligo patients'}, {'measure': 'Correlation between extent/ severity/duration/ activity of vitiligo and the age of onset.', 'timeFrame': 'one year', 'description': 'This via detecting VASI, VES and VIDA scores for vitiligo patients and relating to the age of onset'}, {'measure': 'Detection of possible influence of dietary habits and its relation to metabolic derangements and disease progression', 'timeFrame': 'one year', 'description': 'This via directly addressing dietary habits'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['insulin resistance'], 'conditions': ['Metabolic Syndrome', 'Vitiligo']}, 'referencesModule': {'references': [{'pmid': '36208004', 'type': 'DERIVED', 'citation': 'Ibrahim S, El-Tahlawi S, Mogawer RM, El Ansary M, Esmat S, El-Hawary M. Different vitiligo characteristics as predictors of increased risk of metabolic syndrome and insulin resistance: A case-control study. J Cosmet Dermatol. 2022 Dec;21(12):7170-7177. doi: 10.1111/jocd.15446. Epub 2022 Oct 25.'}]}, 'descriptionModule': {'briefSummary': 'This study aims at detection of possible associated metabolic syndrome with vitiligo and assessment of possible contribution of the age of onset of vitiligo.', 'detailedDescription': "This study aims at detection of incidence of metabolic syndrome in vitiligo patients and possible contribution of the age of onset of the disease. This involves detection of waist circumference, body mass index, index of central obesity, systolic and diastolic arterial blood pressure, fasting blood sugar, high density lipoproteins and triglycerides, in addition to insulin resistance as Homeostatic Model Assessment- insulin resisitance (HOMA-IR) and serum leptin in vitiligo patients. The outcomes will be correlated to extent/ severity/duration/ activity of vitiligo as well as to the age of onset. This is assumed to be of profound impact on vitiligo patients by properly assessing these patients for associated metabolic risk factors and helping prevent such metabolic derangements by detection of possible contributing factors such as insulin resistance and high serum adipokines as leptin.\n\nSince there is temporal relation between nutrition, metabolic derangements and skin diseases where nutritional deficiencies as minerals, vitamins and fatty acids can lead to cutaneous manifestations and , on the other hand; skin diseases could contribute to metabolic derangements and nutritional deficiencies, the investigator's study will focus on nutrition and dietary habits and there possible contribution to any associated metabolic risk in vitiligo patients.\n\nThis is likely to open new horizons in the management of vitiligo, possibly through control of metabolic syndrome risk factors and insulin resistance as well as revealing possible temporal relation to dietary habits that are overlooked in vitiligo patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Vitiligo patients presenting to Dermatology outpatient clinic (Kasr Alainy Teaching Hospitals, Cairo University).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Both genders\n* Patients with non-segmental vitiligo (NSV) and segmental vitiligo\n\nExclusion Criteria:\n\n* Smoking\n* Pregnancy\n* Systemic steroid intake in the last 6 months'}, 'identificationModule': {'nctId': 'NCT03622320', 'briefTitle': 'Metabolic Syndrome in Early Onset Versus Late Onset Vitiligo', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Metabolic Syndrome in Early Onset Versus Late Onset Vitiligo', 'orgStudyIdInfo': {'id': 'Vitiligo & Metabolic syndrome'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Vitiligo patients', 'description': 'Vitiligo patients (100 NSV and 50 segmental) who will be further classified according to age of onset and blood sample will be taken', 'interventionNames': ['Other: Blood sample']}, {'label': 'controls', 'description': 'Matching will be done taking into consideration age, sex, education and socio economic status, blood sample will be taken', 'interventionNames': ['Other: Blood sample']}], 'interventions': [{'name': 'Blood sample', 'type': 'OTHER', 'description': 'Blood sample for fasting blood sugar (FBS), High density lipoproteins (HDL), Triglycerides (TG) ,HOMA-IR, serum leptin', 'armGroupLabels': ['Vitiligo patients', 'controls']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Cairo university hospitals, dermatology outpatient clinic', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Samar El-Tahlawi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo university, dermatology department'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Rania Mogawer', 'investigatorAffiliation': 'Cairo University'}}}}