Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-27 @ 11:54 PM
Study NCT ID:
NCT06673433
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-02
First Post:
2024-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Environmental Factors on the Macro-genome and Metabolism of Obese Patients.
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': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-28', 'studyFirstSubmitDate': '2024-11-02', 'studyFirstSubmitQcDate': '2024-11-02', 'lastUpdatePostDateStruct': {'date': '2025-06-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BMI', 'timeFrame': 'BMI was examed when first join the study, whith through the whole study period, an average of 1 month.', 'description': 'BMI = weight / height squared (kg/m2)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['obesity', 'environment', 'air pollution', 'macrogenomics', 'metabolism'], 'conditions': ['Obesity and Overweight']}, 'descriptionModule': {'briefSummary': 'The present study was designed to include obese patients diagnosed with obesity in the First Affiliated Hospital of Chongqing Medical University and a healthy control population. By analysing the relationship between metabolic parameters and macrogenomes in obesity, identifying key metabolic and macrogenomic differences between obese patients and healthy populations, and establishing the association between environmental factors and obesity-related metabolic disorders, the investigators will be able to provide new biomarkers and intervention targets for obesity prevention and treatment.', 'detailedDescription': "Obese patients who attended the First Hospital of Chongqing Medical University and intended to undergo bariatric surgery were screened according to the inclusion and exclusion criteria. Patients' basic personal information and biological specimens including blood, faeces and urine were collected for metabolic and macro-genomic analyses. Air pollution exposure of the study subjects was collected by telephone follow-up. Metabolite profiles in blood and urine were analysed using liquid chromatography-mass spectrometry (LC-MS). Microbial community composition in faecal samples was analysed using 16S rRNA gene sequencing. Metabolic and macrogenomic differences between obese and control groups were compared using t-test or Mann-Whitney U-test. Logistic regression analyses were used to assess the independent effects of different environmental factors on metabolism and macrogenome. Identify key metabolites and microorganisms associated with obesity using Random Forest and Principal Component Analysis."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study intend to include patients diagnosed with obesity in the First Hospital of Chongqing Medical University.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years;\n* Obese patients with BMI ≥30kg/m2;\n* Patients did not undergo surgical treatment before enrolment;\n* Willing to participate in this study and sign the informed consent form;\n* Complete clinical data.\n\nExclusion Criteria:\n\n* Patients with systemic diseases such as severe cardiorespiratory insufficiency that affect the choice of treatment regimen;\n* Pregnant or lactating women;\n* Patients who are not suitable for enrolment as assessed by the investigator;\n* Patients with incomplete clinical data.'}, 'identificationModule': {'nctId': 'NCT06673433', 'briefTitle': 'The Effects of Environmental Factors on the Macro-genome and Metabolism of Obese Patients.', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Chongqing Medical University'}, 'officialTitle': 'The Effect of Environmental Factors on the Macro-genome and Metabolism of Obese Patients.', 'orgStudyIdInfo': {'id': '202-331-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'the obesity group', 'description': 'Patients diagnosed with obesity (body mass index (BMI) ≥ 28kg/m2)', 'interventionNames': ['Diagnostic Test: obesity']}, {'label': 'the control group', 'description': 'Paticipants with nomal BMI （18.5 - 24 kg/m2)', 'interventionNames': ['Diagnostic Test: health']}], 'interventions': [{'name': 'obesity', 'type': 'DIAGNOSTIC_TEST', 'description': 'Patients diagnosed with obesity (BMI ≥ 28kg/m2)', 'armGroupLabels': ['the obesity group']}, {'name': 'health', 'type': 'DIAGNOSTIC_TEST', 'description': 'the health control group include paticipants with nomal BMI', 'armGroupLabels': ['the control 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}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The Ethics Committee of this Clinical Centre does not allow the disclosure of patient information.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dong Peng', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dong Peng', 'investigatorAffiliation': 'First Affiliated Hospital of Chongqing Medical University'}}}}