Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-26 @ 1:27 AM
Study NCT ID:
NCT06416033
Status:
COMPLETED
Last Update Posted:
2024-11-08
First Post:
2024-05-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Serum Irisin Level In Leprosy Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007918', 'term': 'Leprosy'}, {'id': 'D015441', 'term': 'Leprosy, Tuberculoid'}, {'id': 'D015440', 'term': 'Leprosy, Lepromatous'}], 'ancestors': [{'id': 'D009165', 'term': 'Mycobacterium Infections, Nontuberculous'}, {'id': 'D009164', 'term': 'Mycobacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D056005', 'term': 'Leprosy, Paucibacillary'}, {'id': 'D056006', 'term': 'Leprosy, Multibacillary'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-07', 'studyFirstSubmitDate': '2024-05-10', 'studyFirstSubmitQcDate': '2024-05-10', 'lastUpdatePostDateStruct': {'date': '2024-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'measurement of Serum Irisin', 'timeFrame': '24 hours', 'description': 'comparing the plasma irisin levels in leprosy patients with healthy Participants'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Leprosy', 'Irisin', 'tuberculoid leprosy', 'lepromatous leprosy'], 'conditions': ['Leprosy']}, 'descriptionModule': {'briefSummary': '* Measurement of plasma irisin level in leprosy patients.\n* Correlation of plasma irisin level between leprosy patients and healthy controls.\n* Correlation of plasma irisin level in different leprosy types.', 'detailedDescription': "Leprosy is a chronic granulomatous infectious disease which infects mainly superficial peripheral nerves, mucosa of upper respiratory tract, testicles, bones, and eyes. It's an intracellular infection caused by the acid-fast bacillus, Mycobacterium leprae.\n\nBoth age and sex are important risk factors for leprosy infection, adolescents aged between 10 and 19 years and adults aged more than 30 years are more liable to leprosy, and the possibility of leprosy infection of adult males is twice as much as adult females.\n\nLeprosy evolution involves complex host immune mechanisms that influence the clinical presentation of the disease . the spectral pathology of leprosy can be diagnosed by using two coexisting classification systems. The WHO classification system which is based on the number of lesions and Ridley and Jopling classification system which is based on the histopathology .\n\nThe WHO classification system includes individuals with more than five lesions which are classified as multibacillary (MB) patients, and individuals with less than five lesions which are classified as paucibacillary (PB) patients .While Ridley and Jopling classification system includes tuberculoid leprosy (TT), lepromatous leprosy (LL) and borderline phenotypes: {borderline tuberculoid (BT), mid-borderline (BB), and borderline lepromatous (BL).\n\nTuberculoid leprosy (TT) is characterized by the presence of one to three cutaneous lesions, called plaques. These lesions are circular or oval, erythematous/hypopigmented, hairless, scaly, dry and anesthetic. On the other hand, lepromatous leprosy (LL) is characterized by extensive and multiple bilateral lesions, which may include macules, papules, nodules, and plaques .\n\nThe majority of patients, however, present with the borderline phenotypes. In these phenotypes, the bacterial load correlates with the histological features, borderline tuberculoid (BT) being more closely related to tuberculoid leprosy( TT) patients while borderline lepromatous (BL) to lepromatous leprosy (LL) patients. The borderline states are immunologically unstable and susceptible to the occurrence of leprosy reactions.\n\nIn 1991 the World Health Assembly decided to 'eliminate leprosy as a public health problem' by the year 2000. Elimination was defined as decreasing the disease prevalence globally to less than 1 case per 10,000 populations. In 2000 the World Health Organization (WHO) announced that elimination was reached globally.\n\nIrisin is a protein formed of 112 amino acids. It was discovered in 2012 at Harvard University. And named after an ancient Goddess called Iris, who served as a messenger among the Gods in Greek mythology.\n\nIrisin has been linked to many metabolic diseases, including obesity, lipid metabolism ,cardiovascular disease (CVD), type 2 diabetes mellitus (T2DM) ,polycystic ovary syndrome (PCOS) ,Nonalcoholic fatty liver disease (NAFLD) and metabolic bone diseases ."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study will include patients with leprosy and healthy controls attending in the outpatient clinic of Dermatology, Venereology and Andrology, Aswan University Hospital, Aswan University.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- New cases of leprosy patients.\n\nExclusion Criteria:\n\n* Old cases with leprosy.\n* Patients with cardiovascular disease (CVD) and type 2 diabetes mellitus (T2DM).\n* Patients with polycystic ovary syndrome (PCOS), Nonalcoholic fatty liver disease (NAFLD) and metabolic bone diseases.'}, 'identificationModule': {'nctId': 'NCT06416033', 'briefTitle': 'Serum Irisin Level In Leprosy Patients', 'organization': {'class': 'OTHER', 'fullName': 'Aswan University'}, 'officialTitle': 'Serum Irisin Level In Leprosy Patients', 'orgStudyIdInfo': {'id': 'Irisin Level In Leprosy'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group A :(Leprosy Group)', 'description': 'About 29 patients newly affected with Leprosy and The plasma irisin level of the participants will be measured by enzyme-linked immunosorbent assay (ELISA).', 'interventionNames': ['Procedure: Serum Irisin']}, {'label': 'Group B:(Control Group)', 'description': 'About 29 apparently healthy individuals and The plasma irisin level of the participants will be measured by enzyme-linked immunosorbent assay (ELISA).', 'interventionNames': ['Procedure: Serum Irisin']}], 'interventions': [{'name': 'Serum Irisin', 'type': 'PROCEDURE', 'description': 'Measurement of plasma irisin level in leprosy patients.', 'armGroupLabels': ['Group A :(Leprosy Group)', 'Group B:(Control Group)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aswān', 'country': 'Egypt', 'facility': 'Aswan University Hospital', 'geoPoint': {'lat': 24.09082, 'lon': 32.89942}}], 'overallOfficials': [{'name': 'Moustafa El Taieb, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Dermatology, Venereology and Andrology Faculty of Medicine, Aswan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aswan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident at Dermatology, Venereology and Andrology', 'investigatorFullName': 'Esraa Nagy Zaki Faheem', 'investigatorAffiliation': 'Aswan University'}}}}