Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2026-02-09 @ 9:48 PM
Study NCT ID:
NCT03845868
Status:
RECRUITING
Last Update Posted:
2019-02-19
First Post:
2019-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tongji-Ezhou Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004032', 'term': 'Diet'}, {'id': 'D004781', 'term': 'Environmental Exposure'}, {'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D004787', 'term': 'Environmental Pollution'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood, urine, and DNA were collected by clinicians during the morning after the examinees. Blood samples (5 ml) are collected with ethylenediamine tetra acetic acid anticoagulant tube from peripheral vessels. Plasma, buffy coat, and red blood cell layer are separated. The samples are stored at -80°C for future analyses. All bio-samples will be tracked through an electronic database.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-04-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-16', 'studyFirstSubmitDate': '2019-02-14', 'studyFirstSubmitQcDate': '2019-02-16', 'lastUpdatePostDateStruct': {'date': '2019-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of diabetes', 'timeFrame': '5 years', 'description': 'Type 2 diabetes was diagnosed when FPG ≥ 7.0 mmol/L and/or OGTT2h ≥ 11.1 mmol/L, or using diabetic medication (self-report).'}, {'measure': 'Incidence of metabolic syndrome', 'timeFrame': '5 years', 'description': 'Metabolic syndrome is defined as using the updated National Cholesterol Education Program/Adult Treatment Panel III criteria for Asian Americans. These criteria require three or more of the following components: (1) central obesity (waist circumference of ≥90 cm for men or ≥80 cm for women), (2) triglycerides of ≥1.7 mmol/L, (3) HDL-C of \\<1.03 mmol/L for men or \\<1.30 mmol/L for women, (4) blood pressure of ≥130/85 mmHg or on medication for hypertension, and (5) fasting glucose of ≥5.6 mmol/L.'}, {'measure': 'Diabetic complications', 'timeFrame': 'mean follow up of 10 years', 'description': 'Development of diabetic complications'}, {'measure': 'Incidence of cardiovascular diseases', 'timeFrame': 'mean follow up of 10 years', 'description': 'Cardiovascular death, stroke, myocardial infarction, heart failure'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Cardiovascular Diseases', 'Obesity', 'Metabolic Syndrome', 'Nutritional and Metabolic Diseases', 'Environmental Exposure', 'Risk Factor, Cardiovascular']}, 'referencesModule': {'references': [{'pmid': '36967162', 'type': 'DERIVED', 'citation': 'Sun T, Deng Y, Geng X, Fang Q, Li X, Chen L, Zhan M, Li D, Zhu K, Li H, Liu L. Plasma Alkylresorcinol Metabolite, a Biomarker for Whole-Grain Intake, Is Inversely Associated with Risk of Nonalcoholic Fatty Liver Disease in a Case-Control Study of Chinese Adults. J Nutr. 2022 Apr;152(4):1052-1058. doi: 10.1093/jn/nxab404. Epub 2023 Feb 18.'}, {'pmid': '35091747', 'type': 'DERIVED', 'citation': 'Sun T, Deng Y, Geng X, Fang Q, Li X, Chen L, Zhan M, Li D, Zhu K, Li H, Liu L. Plasma Alkylresorcinol Metabolite, a Biomarker for Whole-Grain Intake, Is Inversely Associated with Risk of Nonalcoholic Fatty Liver Disease in a Case-Control Study of Chinese Adults. J Nutr. 2022 Apr 1;152(4):1052-1058. doi: 10.1093/jn/nxab404.'}]}, 'descriptionModule': {'briefSummary': 'Tongji-Ezhou study (TJEZ) is a prospective cohort study launched at 2013 in EZhou city, Hubei province, with the goal of recruiting and assessing 10,000 individuals and then following them for at least 2 decades. In addition, blood samples would be collected every 3-5 years among 6000 of them to investigate the nutritional biomarkers and potential determinants of chronic diseases such as obesity, type 2 diabetes, metabolic syndrome, and cardiovascular disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Samples were collected at two medical centrals (retired employees at Egang hospital and working employees at Ezhou CDC). The Retirement Office of Egang hospital and Health checkup center of CDC provided a list of the individuals and invited them to participant in our study.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (i) permanent residence in Ezhou district (minimum of 9 months); (ii) written informed consent; (iii) age ≥ 20 years old at the time of enrolling in the study.\n\nExclusion Criteria:\n\n* (i) with chemotherapy or radiotherapy for cancer and other severe diseases.'}, 'identificationModule': {'nctId': 'NCT03845868', 'acronym': 'TJEZ', 'briefTitle': 'Tongji-Ezhou Study', 'organization': {'class': 'OTHER', 'fullName': 'Huazhong University of Science and Technology'}, 'officialTitle': 'Tongji-Ezhou Prospectively Cohort Study', 'orgStudyIdInfo': {'id': 'TJEZ2013'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Egang hospital physical examination center', 'interventionNames': ['Other: Dietary and environmental exposure (Observational study)']}, {'label': 'Ezhou CDC physical examination center', 'interventionNames': ['Other: Dietary and environmental exposure (Observational study)']}], 'interventions': [{'name': 'Dietary and environmental exposure (Observational study)', 'type': 'OTHER', 'armGroupLabels': ['Egang hospital physical examination center', 'Ezhou CDC physical examination center']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Liegang Liu, PhD', 'role': 'CONTACT', 'email': 'liegangliu@gmail.com', 'phone': '+86-27-83650522'}, {'name': 'Cheng Luo, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Liangkai Chen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Zhou Li, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jiawei Yin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huazhong University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice dean of School of Public Health, Tongji Medical College', 'investigatorFullName': 'Liegang Liu', 'investigatorAffiliation': 'Huazhong University of Science and Technology'}}}}