Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-29 @ 5:15 AM
Study NCT ID:
NCT05177250
Status:
UNKNOWN
Last Update Posted:
2022-07-27
First Post:
2021-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association of Bisphenol A,Paraben Exposure and Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002851', 'term': 'Chromatography, High Pressure Liquid'}], 'ancestors': [{'id': 'D002853', 'term': 'Chromatography, Liquid'}, {'id': 'D002845', 'term': 'Chromatography'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2023-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-26', 'studyFirstSubmitDate': '2021-12-09', 'studyFirstSubmitQcDate': '2021-12-15', 'lastUpdatePostDateStruct': {'date': '2022-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bisphenol A and paraben detection in urine samples of diabetic (n=50) and non diabetic persons (n=50)', 'timeFrame': 'Baseline', 'description': 'Evaluation of bisphenol A and Paraben detection in urine samples from type 2 diabetic adult patients compared with non diabetic persons using HPLC'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type2 Diabetes', 'Bisphenol A']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the association between BPA , paraben levels and type 2 DM patients', 'detailedDescription': 'The first phase of the study will include a questionnaire :\n\n* The cases and control will be asked about demographic information such as residence, age, education, and occupation.\n* History of discovery of diabetes.\n* Exposure to products and materials such as polycarbonate plastics, cosmetics and beverages containing bisphenol A and paraben and it will be evaluated through exposure sheet through asking about dietary exposure, Environmental exposure and medical exposure.\n\nThen clinical evaluation including:\n\n* Full clinical examination will be performed for cases and control.\n* Anthropological data:\n\ntheir weights, heights and waist circumference will be measured. The body mass index (BMI) will be calculated by weight (kg)/height (m)2 formula.\n\n* Investigations: routine and specific investigation as blood glucose level, HbA1c and lipid profile.\n* Urine specimens will be collected in clean, glass containers will labeled with the subject identification number. Turbid sample or those containing blood will be excluded.\n* All specimens will be stored frozen below 20 degree centigrade.\n* Urine samples will be analyzed by High Performance liquid chromatograph (HPLC) to detect bispenol A and parabens levels.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult patients ( 18 y or elder).\n2. Type 2 DM\n\nExclusion Criteria:\n\n* Type 1 DM\n* Less than 18 y\n* History of chronic diseases such as liver failure, cardiac patients……etc'}, 'identificationModule': {'nctId': 'NCT05177250', 'briefTitle': 'Association of Bisphenol A,Paraben Exposure and Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'The Possible Association Between Bisphenol A, Paraben Exposure and Type 2 Diabetic Adult Patients.', 'orgStudyIdInfo': {'id': 'bisphenol A,paraben, type 2DM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Case group', 'description': '50 cases with type 2 DM.', 'interventionNames': ['Device: HPLC']}, {'type': 'OTHER', 'label': 'Control group', 'description': '50 subjects not diabetics.', 'interventionNames': ['Device: HPLC']}], 'interventions': [{'name': 'HPLC', 'type': 'DEVICE', 'description': 'taking urine samples from participants and analyze these samples to detect bisphenol A and paraben', 'armGroupLabels': ['Case group', 'Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed Fathy', 'role': 'CONTACT', 'email': 'Drahmed.fathy8090@gmail.com', 'phone': '000000000'}], 'facility': 'Ahmed Fathy', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Ahmed Awad, PHD', 'role': 'CONTACT', 'email': 'Drahmedfathy8090@kasralainy.edu.eg', 'phone': '201063348234'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer of forensic medicine and clinical toxicology', 'investigatorFullName': 'Ahmed Fathy Hussein Awad', 'investigatorAffiliation': 'Cairo University'}}}}