Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 10:43 PM
Study NCT ID:
NCT01084967
Status:
RECRUITING
Last Update Posted:
2021-04-21
First Post:
2010-03-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Genetics of Obesity in Chinese Youngs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'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'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood,fasting serum, morning urine and feces'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 8000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-20', 'studyFirstSubmitDate': '2010-03-10', 'studyFirstSubmitQcDate': '2010-03-10', 'lastUpdatePostDateStruct': {'date': '2021-04-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-03-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['obesity', 'metabolic syndrome', 'genetic risk markers', 'copy number variation'], 'conditions': ['Obesity', 'Metabolic Syndrome']}, 'referencesModule': {'references': [{'pmid': '33950216', 'type': 'DERIVED', 'citation': 'Hong J, Bo T, Xi L, Xu X, He N, Zhan Y, Li W, Liang P, Chen Y, Shi J, Li D, Yan F, Gu W, Wang W, Liu R, Wang J, Wang Z, Ning G. Reversal of Functional Brain Activity Related to Gut Microbiome and Hormones After VSG Surgery in Patients With Obesity. J Clin Endocrinol Metab. 2021 Aug 18;106(9):e3619-e3633. doi: 10.1210/clinem/dgab297.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to explore the pathogenesis and genetic susceptibility of obese subjects,providing a convincing argument for further treatment of obesity and metabolic syndrome.', 'detailedDescription': 'Obesity has become a major worldwide challenge to public health, owing to an interaction between the obesogenic environment and a strong genetic contribution.Previous studies found that genetic factors determine 40%-70% of obese phenotype.Under such circumstances, the screening of obesity susceptibility gene is particularly important for society or family to take measures to prevent obesity.\n\nRecent extensive genome-wide association studies(GWASs) have identified numerous single nucleotide polymorphisms associated with obesity,but these loci together account for only a small fraction of the known heritable component.Two studies in 2010 Nature,for the first time, put rare copy number variation (CNV)in association with severe early-onset obesity.Their significance lie not only in the discovery of the pathogenic genes of severe early-onset obesity but,more importantly,in providing new strategies for finding out genes that cause complex diseases.\n\nObese patients and healthy lean controls proved by a series of blood biochemical examinations will be enrolled in this study.The present study intends to use the techniques such as enzyme-linked immunosorbent assay, real-time fluorescence quantitative PCR,gene chip,construction of viral vectors,transfection, taking advantage of the established database,by means of serum assays and functional tests, associate copy number variation with obesity phenotype to explain the root cause of obesity.Meanwhile biomarkers, gut flora and genetic risk factors will be evaluated in the study subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'minimumAge': '14 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The population from which cohorts will be selected include students, residents, staff, and/or faculty who are present on Shanghai Jiaotong University school of medicine, and surrounding areas.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* body mass index (BMI)≥ 30kg/m2\n* predominantly east China to minimize population stratification\n* willing and able to provide informed consent\n\nExclusion Criteria:\n\n* pregnancy/lactation\n* Cushing syndrome\n* Hypothyroidism\n* obesity caused by pituitary and hypothalamic lesions\n* drug related obesity\n* history of major psychiatric illness'}, 'identificationModule': {'nctId': 'NCT01084967', 'acronym': 'GOCY', 'briefTitle': 'Genetics of Obesity in Chinese Youngs', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'Study of Clinical Characteristics and Genetic Susceptibility in Chinese Obese Youngs', 'orgStudyIdInfo': {'id': 'CCEMD008'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy lean control group', 'description': 'The healthy lean controls consisted of age-, sex- and geography-matched young volunteers, or "golden standard" lean controls from China Cardiometabolic Disease and Cancer Cohort Study (4C Study).\n\nHealthy volunteers:\n\n1. BMI:18.5-22.9kg/m2;\n2. Age:14-30 years old;\n3. To be proved normal by the examinations of liver and kidney function,blood lipids profile,FBG, PBG, fasting insulin and HbA1c.\n\nControls from 4C Study:\n\n1. 17.0≤BMI≤23.0kg/m2 and waist circumference \\<85cm for males and \\<80cm for females;\n2. 1.8≤LDL-c≤3.4mmol/l;\n3. FBG\\<6.1, PBG\\<7.8;\n4. HOMA-IR\\<2.5;\n5. BP \\<140/90mmHg;\n6. eGFR\\>60mL/(min·1.73 m2), ALT\\<40IU/L, AST\\<40IU/L;\n7. Excluding the history of hyperthyroidism, digestive system diseases, malignant tumors, infectious diseases (hepatitis B) and other systemic wasting diseases; Severe dysfunction of heart, lung and kidney;\n8. Not using antihypertensive, hypoglycemic and lipid-lowering drugs；\n9. No history of smoking.'}, {'label': 'obesity group', 'description': '1. BMI ≥30kg/m2;\n2. Age:14-30 years old; obesity group 4000, lean healthy control group 4000'}]}, 'contactsLocationsModule': {'locations': [{'zip': '200025', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guang Ning, MD.PhD', 'role': 'CONTACT', 'email': 'guangning@medmail.com.cn', 'phone': '86-21-64370045', 'phoneExt': '665340'}, {'name': 'Jie Hong, PhD', 'role': 'CONTACT', 'email': 'hongjie13d@hotmail.com', 'phone': '86-21-64370045', 'phoneExt': '665345'}, {'name': 'Guang Ning, MD.PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Shanghai Jiao Tong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Guang Ning, MD.PhD', 'role': 'CONTACT', 'email': 'guangning@medmail.com.cn', 'phone': '86-21-64370045', 'phoneExt': '665340'}, {'name': 'Jie Hong, PhD', 'role': 'CONTACT', 'email': 'hongjie13d@hotmail.com', 'phone': '86-21-64370045', 'phoneExt': '665345'}], 'overallOfficials': [{'name': 'Guang Ning, MD.PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Shanghai Jiao Tong University School of Medicine'}, {'name': 'Jie Hong, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Jiao Tong University School of Medicine'}, {'name': 'Jiqiu Wang, MD.PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Jiao Tong University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Guang Ning', 'investigatorAffiliation': 'Shanghai Jiao Tong University School of Medicine'}}}}