Ignite Creation Date:
2025-12-26 @ 5:21 PM
Ignite Modification Date:
2025-12-26 @ 5:21 PM
Study NCT ID:
NCT06239506
Status:
RECRUITING
Last Update Posted:
2024-02-02
First Post:
2023-12-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Novel Brominated and Organophosphate Flame Retardants and Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': "Blood samples were collected in vacutainer tubes without anticoagulants. The levels of FPG, TG, TC, HDL-C, and LDL-C were measured at the above hospital. The whole blood samples in tubes were centrifuged at 4 000 r min-1 for 10 min, and were placed in two sample tubes. One n was used for determination of FPG and lipid fractions in the hospital. And the other was maintained at -20 ℃ for FRs analysis. FPG was determined enzymatically, and lipid fractions were analyzed using an enzymatic spectrophotometric method in serum . Total lipids (TLs) were counted using Phillip's formula: TL = 2.27 × TC + TG + 0.623."}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 340}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-25', 'studyFirstSubmitDate': '2023-12-11', 'studyFirstSubmitQcDate': '2024-01-25', 'lastUpdatePostDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'alternative FRs', 'timeFrame': '2022.1-2024.12', 'description': 'Determination of FRs was performed by a gas chromatography triple quadrupole mass spectrometry (GC-MS/MS, TQ-8050NX, Shimadzu, Japan) equipped with an electron ionization (EI+) ion source.'}], 'secondaryOutcomes': [{'measure': 'levels of FPG', 'timeFrame': '2022.1-2024.12', 'description': 'Detecting blood sugar using a biochemical analyzer'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes', 'Novel Brominated Flame Retardants', 'Organophosphate Flame Retardants', 'Fasting Plasma Glucose']}, 'descriptionModule': {'briefSummary': 'As alternative flame retardants (FRs), novel brominated flame retardants (NBFRs) and organophosphate flame retardants (OPFRs) are ubiquitous in environment and may cause endocrine disruption effects. The associations between traditional endocrine-disrupting chemicals (EDCs) and type 2 diabetes have been extensively reported in epidemiological studies. To date, however, human-based evidence on the effects of NBFRs and OPFRs is lacking. The investigators conducted a case-control study of 344 participants aged 25-80 years from Shandong Province, East China, to assess potential associations between serum NBFR and OPFR concentrations and etiology of type 2 diabetes for the first time.', 'detailedDescription': 'In this study, the investigators conducted a case-control study in Shandong Province, East China, to evaluate the associations between serum NBFR and OPFR and risk of type 2 diabetes. The aims of the present study were to (1) evaluate the associations between alternative FRs in human serum and the risk of type 2 diabetes, (2) assess the relationships between alternative FR concentrations and fasting plasma glucose (FPG), (3) investigate the correlations between alternative FRs and concentrations of lipid fractions, including TG, TC, high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C), and (4) clarify the joint effects of NBFR and OPFR mixtures on the risk of type 2 diabetes'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'we will conduct a case-control study of 340 participants from Shandong 116 Province, East China, to evaluate the associations between serum NBFR and OPFR and risk of type 2 diabetes.', 'eligibilityCriteria': 'Inclusion Criteria:\n\nGroup of Type 2 diabetes patients:\n\n1. age 18 \\~ 75 years old;\n2. type 2 diabetes patients diagnosed in the First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital of Shandong Province) , HBA1C ≥7.0% and \\<10.5% ;\n3. patients signed informed consent.\n\nControl Group:\n\n1. age 18 \\~ 75 years old;\n2. healthy population recruited from the First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital of Shandong Province) ;\n3. living in the monitoring area for more than 6 months within 12 months;\n4. normal thyroid function and no history of thyroid cancer were needed in the control group;\n5. Fasting Blood Glucose level of 0.7 mmol/l was needed in the Control Group of Type 2 diabetes Mellitus Without History of diabetes;\n6. patients with informed consent.\n\nExclusion Criteria:\n\n* Group of Type 2 diabetes:\n\n 1. pregnant, lactating women, patients with acute cardiac cerebrovascular disease;\n 2. patients with severe liver and Renal Impairment (related laboratory tests more than 2 times the normal) ;\n 3. patients with Type 1 diabetes;\n 4. participants in other clinical trials within 3 months;\n 5. patients with malignant tumors.\n 6. has the disease and so on serious anemia, is not suitable to carry on the patient which the blood draws the test.\n\nControl Group:\n\n1. patients with serious heart, liver or kidney disease;\n2. patients with iodine or Thyroid hormone;\n3. patients with confirmed malignant tumor;\n4. pregnant women or those who have recently taken contraception or estrogen.'}, 'identificationModule': {'nctId': 'NCT06239506', 'briefTitle': 'Novel Brominated and Organophosphate Flame Retardants and Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Qianfoshan Hospital'}, 'officialTitle': 'Exposure to Novel Brominated and Organophosphate Flame Retardants and Associations With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'YXLL-KY-2021-064-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'type 2 diabetes', 'description': 'Case group participants were recruited from patients diagnosed with type 2 diabetes and undergoing medical treatment at the First Affiliated Hospital of Shandong First Medical University(Shandong Provincial hospital)', 'interventionNames': ['Other: no intervention']}, {'label': 'Control group', 'description': 'Control group participants were recruited from residents living in Jinan and undergoing physical examinations at the same hospital.', 'interventionNames': ['Other: no intervention']}], 'interventions': [{'name': 'no intervention', 'type': 'OTHER', 'description': 'no intervention', 'armGroupLabels': ['Control group', 'type 2 diabetes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250000', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guan X, Dr.', 'role': 'CONTACT', 'email': 'gxlwho@163.com', 'phone': '8613356677195'}, {'name': 'Jiao Wenjiao, Dr.', 'role': 'CONTACT', 'email': 'Qykyc309@163.com', 'phone': '860531-89269890'}], 'facility': 'The First Affiliated Hospital of Shandong First Medical University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Guan Xiaoling, Dr.', 'role': 'CONTACT', 'email': 'gxlwho@163.com', 'phone': '8613356677195'}, {'name': 'Jiao Wenjiao, Dr.', 'role': 'CONTACT', 'email': 'Qykyc309@163.com', 'phone': '860531-89269890'}], 'overallOfficials': [{'name': 'Tian Hui, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shandong First Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xiaoling Guan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Xiaoling Guan', 'investigatorAffiliation': 'Qianfoshan Hospital'}}}}