Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-25 @ 8:41 PM
Study NCT ID:
NCT05549869
Status:
UNKNOWN
Last Update Posted:
2022-09-22
First Post:
2022-09-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of Serum Leptin in Vitiligo Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-12-06', 'releaseDate': '2024-10-22'}], 'estimatedResultsFirstSubmitDate': '2024-10-22'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D014820', 'term': 'Vitiligo'}], 'ancestors': [{'id': 'D017496', 'term': 'Hypopigmentation'}, {'id': 'D010859', 'term': 'Pigmentation Disorders'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2023-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-18', 'studyFirstSubmitDate': '2022-09-18', 'studyFirstSubmitQcDate': '2022-09-18', 'lastUpdatePostDateStruct': {'date': '2022-09-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'level of serum leptin', 'timeFrame': '6 month', 'description': 'Evaluation of serum leptin in vitiligo patients and control Assessing its correlation to the body mass index and disease dermographic data .'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vitiligo']}, 'referencesModule': {'references': [{'pmid': '32155629', 'type': 'BACKGROUND', 'citation': 'Bergqvist C, Ezzedine K. Vitiligo: A Review. Dermatology. 2020;236(6):571-592. doi: 10.1159/000506103. Epub 2020 Mar 10.'}, {'pmid': '34724392', 'type': 'BACKGROUND', 'citation': 'Schneider BJ, Naidoo J, Santomasso BD, Lacchetti C, Adkins S, Anadkat M, Atkins MB, Brassil KJ, Caterino JM, Chau I, Davies MJ, Ernstoff MS, Fecher L, Ghosh M, Jaiyesimi I, Mammen JS, Naing A, Nastoupil LJ, Phillips T, Porter LD, Reichner CA, Seigel C, Song JM, Spira A, Suarez-Almazor M, Swami U, Thompson JA, Vikas P, Wang Y, Weber JS, Funchain P, Bollin K. Management of Immune-Related Adverse Events in Patients Treated With Immune Checkpoint Inhibitor Therapy: ASCO Guideline Update. J Clin Oncol. 2021 Dec 20;39(36):4073-4126. doi: 10.1200/JCO.21.01440. Epub 2021 Nov 1.'}, {'pmid': '35169000', 'type': 'BACKGROUND', 'citation': 'Aryanian Z, Shirzadian A, Farzaneh S, Goodarzi A, Azizpour A, Hatami P. Metabolic derangement in patients with vitiligo: a cross-sectional study. J Investig Med. 2022 Apr;70(4):963-966. doi: 10.1136/jim-2021-002062. Epub 2022 Feb 15.'}, {'pmid': '33807959', 'type': 'BACKGROUND', 'citation': 'de Oliveira Dos Santos AR, de Oliveira Zanuso B, Miola VFB, Barbalho SM, Santos Bueno PC, Flato UAP, Detregiachi CRP, Buchaim DV, Buchaim RL, Tofano RJ, Mendes CG, Tofano VAC, Dos Santos Haber JF. Adipokines, Myokines, and Hepatokines: Crosstalk and Metabolic Repercussions. Int J Mol Sci. 2021 Mar 5;22(5):2639. doi: 10.3390/ijms22052639.'}, {'pmid': '29248361', 'type': 'BACKGROUND', 'citation': 'Mechanick JI, Zhao S, Garvey WT. Leptin, An Adipokine With Central Importance in the Global Obesity Problem. Glob Heart. 2018 Jun;13(2):113-127. doi: 10.1016/j.gheart.2017.10.003. Epub 2017 Dec 13.'}]}, 'descriptionModule': {'briefSummary': 'Evaluation of serum leptin in vitiligo patients and control Assessing its correlation to the body mass index and disease dermographic data .', 'detailedDescription': ', leptin is supposed to contribute to vitiligo pathogenesis through promoting the release of pro-inflammatory mediators such as tumor necrosis factor α "TNF," IL-2 and IL-6, as well as enhancing cytotoxic T cells "CD8" recruitment and inhibiting the functions of regulatory T cells "Tregs". Leptin can also aid in induction of oxidative stress by activating nicotinamide adenine dinucleotide phosphate (NADPH) oxidase• Venous blood samples will be taken from patients and controls to evaluate serum leptin: Morning samples will be taken after 12-h overnight fast in plain vacutainer tubes and directly centrifuged (1098 g for 15 min).\n\n* Sera will be then collected in plain, capped, 5 ml centrifuge tubes "Eppendorf" and freezed at -20ᵒC in a well-monitored freezer until the analysis is performed• Serum leptin will be quantitatively assessed in vitro using DRG leptin Sandwich Enzyme Linked Immuno-Sorbent Assay "ELISA".\n* ELISA will be performed according to manufacturer\'s guidelines where each run included a standard curve.\n* Using the mean absorbance value for each sample, the corresponding concentration from the standard curve will be determined.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients with vitiligo who are above the age of 18 years\n\nExclusion Criteria:\n\n* Patients with other autoimmune diseases'}, 'identificationModule': {'nctId': 'NCT05549869', 'briefTitle': 'Assessment of Serum Leptin in Vitiligo Patients', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Assessment of Serum Leptin in Vitiligo Patients', 'orgStudyIdInfo': {'id': 'soh-med-22-09-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'group A', 'description': 'obese with vitligo', 'interventionNames': ['Diagnostic Test: serum leptin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group b', 'description': 'obese without vitligo', 'interventionNames': ['Diagnostic Test: serum leptin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group C', 'description': 'non obese with vitiligo', 'interventionNames': ['Diagnostic Test: serum leptin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group D', 'description': 'non obese without vitiligo', 'interventionNames': ['Diagnostic Test: serum leptin']}], 'interventions': [{'name': 'serum leptin', 'type': 'DIAGNOSTIC_TEST', 'description': 'Evaluation of serum leptin in vitiligo patients and control Assessing its correlation to the body mass index leptin is supposed to contribute to vitiligo pathogenesis through promoting the release of pro-inflammatory mediators', 'armGroupLabels': ['group A', 'group C', 'group D', 'group b']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'country': 'Egypt', 'contacts': [{'name': 'Magdy m amin, professor', 'role': 'CONTACT'}], 'facility': 'Sohag University Hospital', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'doaa z amin, resident', 'role': 'CONTACT', 'email': 'doaa_zaghloul_post@med.sohag.edu.eg', 'phone': '01019096561'}, {'name': 'wafaa m Abdel- majeed, Ass.Professor', 'role': 'CONTACT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'dermatology and andrology resident in luxor international hospital', 'investigatorFullName': 'Doaa Zaghloul Amin', 'investigatorAffiliation': 'Sohag University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-10-22', 'type': 'RELEASE'}, {'date': '2024-12-06', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Doaa Zaghloul Amin, dermatology and andrology resident in luxor international hospital, Sohag University'}}}}