Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-25 @ 5:17 PM
Study NCT ID:
NCT06670703
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-11-01
First Post:
2024-10-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Clinical Study of the Effects of Environmental Pollution on Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050154', 'term': 'Adiposity'}], 'ancestors': [{'id': 'D050218', 'term': 'Body Fat Distribution'}, {'id': 'D001837', 'term': 'Body Weights and Measures'}, {'id': 'D001824', 'term': 'Body Constitution'}, {'id': 'D010808', 'term': 'Physical Examination'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D001823', 'term': 'Body Composition'}, {'id': 'D001669', 'term': 'Biochemical Phenomena'}, {'id': 'D055598', 'term': 'Chemical Phenomena'}, {'id': 'D008660', 'term': 'Metabolism'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2011-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-31', 'studyFirstSubmitDate': '2024-10-31', 'studyFirstSubmitQcDate': '2024-10-31', 'lastUpdatePostDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of obesity', 'timeFrame': 'From 18 years old until the developing obesity, through study completion, an average of 5 year.', 'description': 'the time for overweight to obesity'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['air pollution', 'obesity', 'prevalence', 'overweight', 'environment'], 'conditions': ['Obesity and Overweight']}, 'descriptionModule': {'briefSummary': 'This study aims to assess the effects of environmental pollution (including environmental indicators such as PM2.5, PM5, PM10, SO2, NOX, O3, and greening index) on obese patients and to explore the possible mechanisms by which environmental pollution promotes obesity.', 'detailedDescription': 'Firstly, the effects of environmental pollution on obese patients were investigated by analysing the baseline conditions and obesity levels (including BMI, waist circumference, hip circumference, etc.) and underlying diseases of obese patients in regions with different pollution levels. Secondly, the association between environmental pollution levels on blood test characteristics (including renal function, sex hormones, glucose tolerance test, trace elements, liver function and blood routine) of obese patients was investigated to find possible mechanisms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This is a retrospective observational study, which is expected to include patients diagnosed with obesity ( body mass index (BMI) ≥ 28 kg/m2).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years;\n* obese patients with BMI ≥30;\n* patients without surgical treatment prior to enrolment;\n* willingness to participate in the study and sign an informed consent form;\n* complete clinical data.\n\nExclusion Criteria:\n\n* patients with systemic diseases such as severe cardiorespiratory insufficiency affecting the choice of treatment regimen;\n* patients assessed by the investigator to be inappropriate for enrolment;\n* patients with incomplete clinical data.'}, 'identificationModule': {'nctId': 'NCT06670703', 'briefTitle': 'A Clinical Study of the Effects of Environmental Pollution on Obesity', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Chongqing Medical University'}, 'officialTitle': 'A Clinical Study of the Effects of Environmental Pollution on Obesity', 'orgStudyIdInfo': {'id': 'ZZ2024-350-02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'the obesity group', 'description': "Obese patients attending the First Affiliated Hospital of Chongqing Medical University, the Affiliated Hospital of Yunnan University, and the Second People's Hospital of Qujing City.", 'interventionNames': ['Diagnostic Test: Obesity']}], 'interventions': [{'name': 'Obesity', 'type': 'DIAGNOSTIC_TEST', 'description': 'diagnosis as obese patients', 'armGroupLabels': ['the obesity group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400016', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'country': 'China', 'facility': 'The First Affiliated Hospital of Chongqing Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'zip': '650000', 'city': 'Kunming', 'state': 'Yunnan', 'country': 'China', 'facility': 'Affiliated Hospital of Yunnan University', 'geoPoint': {'lat': 25.03889, 'lon': 102.71833}}, {'zip': '650000', 'city': 'Kunming', 'state': 'Yunnan', 'country': 'China', 'facility': "The Second People's Hospital of Qujing", 'geoPoint': {'lat': 25.03889, 'lon': 102.71833}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Ethics committees of the clinical centres where the studies were conducted did not allow the release of patient data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dong Peng', 'class': 'OTHER'}, 'collaborators': [{'name': 'Affiliated Hospital of Yunnan University', 'class': 'OTHER'}, {'name': "The Second People's Hospital of Qujing", 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dong Peng', 'investigatorAffiliation': 'First Affiliated Hospital of Chongqing Medical University'}}}}