Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
Study NCT ID:
NCT06694012
Status:
RECRUITING
Last Update Posted:
2024-12-04
First Post:
2024-11-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Osaka Cardiometabolic Epidemiological Study: Ohtori Study Part 2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D033461', 'term': 'Hyperuricemia'}, {'id': 'D006073', 'term': 'Gout'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D056128', 'term': 'Obesity, Abdominal'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000070657', 'term': 'Crystal Arthropathies'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D011686', 'term': 'Purine-Pyrimidine Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'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': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood samples stored in serum.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2050-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-29', 'studyFirstSubmitDate': '2024-11-15', 'studyFirstSubmitQcDate': '2024-11-15', 'lastUpdatePostDateStruct': {'date': '2024-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2050-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Type 2 diabetes is diagnosed based on the results of a fasting blood glucose test and medication history.', 'timeFrame': 'Investigators plan to conduct follow-up examinations at intervals of one to two years.', 'description': 'Type 2 diabetes at baseline and follow-up examination is defined if the fasting plasma glucose level is ≥126 mg/dL, if the A1c level is ≥6.5%, or if the participant is taking medications or using injectables such as insulin to lower blood glucose levels at the baseline and follow-up examinations.'}, {'measure': 'Hypertension is diagnosed based on the results of blood pressure measurement and medication history.', 'timeFrame': 'Investigators plan to conduct follow-up examinations at intervals of one to two years. plan to conduct follow-up examinations at intervals of one to two years.', 'description': 'Hypertension is diagnosed if the systolic blood pressure is ≥140 mmHg, the diastolic blood pressure is ≥90 mmHg, or the participant is taking antihypertensive medications.'}, {'measure': 'Dyslipidemia is diagnosed based on the National Cholesterol Education Program (NCEP) Adult Treatment Panel III guidelines.', 'timeFrame': 'Investigators plan to conduct follow-up examinations at intervals of one to two years. plan to conduct follow-up examinations at intervals of one to two years.', 'description': 'Dyslipidemia is diagnosed based on the following criteria:Total cholesterol: ≥200 mg/dL (high); LDL cholesterol: ≥130 mg/dL (high); HDL cholesterol: \\<40 mg/dL (low in men), \\<50 mg/dL (low in women); or triglycerides: ≥150 mg/dL (high).'}, {'measure': 'Metabolic syndrome is diagnosed based on the Joint Interim Statement published in Circulation. 2009 Oct 20;120(16):1640-5.', 'timeFrame': 'Investigators plan to conduct follow-up examinations at intervals of one to two years. plan to conduct follow-up examinations at intervals of one to two years.', 'description': 'An individual is diagnosed with metabolic syndrome if they meet three or more of the following criteria:\n\n1. Abdominal obesity (waist circumference):\n\n Men: ≥90 cm Women: ≥80 cm\n2. Elevated triglycerides:\n\n Triglycerides ≥150 mg/dL, or receiving treatment for elevated triglycerides.\n3. Low HDL cholesterol:\n\n Men: \\<40 mg/dL Women: \\<50 mg/dL, or receiving treatment for low HDL cholesterol.\n4. Elevated blood pressure:\n\n Systolic blood pressure ≥130 mmHg, diastolic blood pressure ≥85 mmHg, or receiving antihypertensive treatment.\n5. Elevated fasting blood glucose:\n\nFasting blood glucose ≥100 mg/dL, or receiving treatment for elevated blood glucose.'}, {'measure': 'Hyperuricemia is defined based on fasting serum uric acid levels and the use of oral medication.', 'timeFrame': 'Investigators plan to conduct follow-up examinations at intervals of one to two years. plan to conduct follow-up examinations at intervals of one to two years.', 'description': 'Hyperuricemia is diagnosed if the fasting serum uric acid levels is \\>7.0 mg/dL for men, \\>7.0 mg/dL for women, or if the participant is taking uric acid-lowering medication.'}, {'measure': 'Low eGFR was define based on the Modification of Diet in Renal Disease study equation for Japanese.', 'timeFrame': 'Investigators plan to conduct follow-up examinations at intervals of one to two years. plan to conduct follow-up examinations at intervals of one to two years.', 'description': 'Low eGFR was defined if eGFR was less than 60 mL/min/1.73 m², regardless of the presence of proteinuria.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Type 2 Diabetes Mellitus', 'Hypertension', 'Hyperlipidemia', 'Dyslipidemia', 'Hyperuricemia', 'obesity', 'Abdominal obesity', 'Visceral fat', 'Visceral adiposity', 'Chronic Kidney Disease', 'Japanese', 'Metabolic Syndrome', 'Insulin Sensitivity', 'Insulin Resistance'], 'conditions': ['Type 2 Diabetes Mellitus (T2DM)', 'Type 2 Diabetes', 'Diabetes Mellitus', 'Hypertension', 'Hyperglycemia', 'Hyperlipidemia', 'Dyslipidemia', 'Hyperuricemia or Gout', 'Hyperuricemia, Gout', 'Obesity', 'Obesity/Epidemiology', 'Obesity, Abdominal', 'Central Obesity', 'Visceral Fat', 'Chronic Kidney Disease(CKD)', 'Atherosclerosis', 'Metabolic Syndrome', 'Hepatic Steatosis', 'Insulin Sensitivity/Resistance']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the relationship between body fat distribution measured by CT scan and related risk factors with the risk of incident metabolic and cardiovascular disease in a prospective cohort study of Japanese men and women. The investigators will also investigate novel risk factors for metabolic and cardiovascular disease using molecular weight-based metallomics analysis.', 'detailedDescription': 'Obesity is on the rise worldwide and is the most important risk factor for lifestyle-related diseases, including type 2 diabetes, hypertension, dyslipidemia, metabolic syndrome, ischemic heart disease, cerebrovascular disease, hyperuricemia, and chronic kidney disease. In addition, it has been reported that the distribution of fat is more important than the total amount of fat in the body, and the importance of visceral fat accumulation in the abdomen has been reported.\n\nAlthough visceral fat accumulation and insulin resistance have been reported to be important upstream factors in the development of lifestyle-related diseases, the major target organs of insulin are not only adipose tissue, but also extremely important tissues such as muscle and liver, and ectopic fat accumulation in these tissues has attracted attention. However, there are few prospective cohort studies that have evaluated fat accumulation in adipose tissue, liver, and muscle simultaneously.\n\nIt has been reported that Japanese people have more visceral fat than Caucasians in the United States, even at the same body mass index level, and are at high risk for type 2 diabetes, so research on Japanese people is of great importance.\n\nIn addition, the role of trace elements in the body is attracting attention. In this cohort study, the investigators will also examine the relationship between trace elements in the body and the prevalence and incidence of lifestyle-related diseases.\n\nThe purpose of this study is to establish a prospective cohort study that evaluates visceral fat, subcutaneous fat, intrahepatic fat accumulation, and intramuscular fat using computed tomography imaging and to clarify the relationship with lifestyle-related diseases such as type 2 diabetes, hypertension, dyslipidemia, metabolic syndrome, ischemic heart disease, cerebrovascular disease, hyperuricemia, and chronic kidney disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Japanese men and women aged 20 years or older who plan to undergo a health examination at the Ohtori Health Promotion Center in Sakai, Osaka, Japan, after November 2024 and who agree to participate in this study.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\-\n\nExclusion Criteria:\n\n* Women who may be pregnant'}, 'identificationModule': {'nctId': 'NCT06694012', 'acronym': 'OCES-2', 'briefTitle': 'Osaka Cardiometabolic Epidemiological Study: Ohtori Study Part 2', 'organization': {'class': 'OTHER', 'fullName': 'Osaka Metropolitan University'}, 'officialTitle': 'Osaka Cardiometabolic Epidemiological Study: Ohtori Study Part 2', 'orgStudyIdInfo': {'id': '2024-030'}, 'secondaryIdInfos': [{'id': 'JP23K17444', 'type': 'OTHER_GRANT', 'domain': 'Japan Society for the Promotion of Science'}]}, 'contactsLocationsModule': {'locations': [{'zip': '5938324', 'city': 'Sakai', 'state': 'Osaka', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Yonezo Hikita, MD, PhD', 'role': 'CONTACT', 'email': 'ocespart2@gmail.com'}], 'facility': 'The Ohtori Health Promotion Center', 'geoPoint': {'lat': 34.58216, 'lon': 135.46653}}], 'centralContacts': [{'name': 'Tomoshige Hayashi, MD, PhD', 'role': 'CONTACT', 'email': 'thayashi@omu.ac.jp', 'phone': '81-6-6645-3751'}, {'name': 'Kyoko Sato, MD, PhD', 'role': 'CONTACT', 'email': 'ksato@omu.ac.jp', 'phone': '81-6-6645-3751'}], 'overallOfficials': [{'name': 'Tomoshige Hayashi, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Osaka Metropolitan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Osaka Metropolitan University', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Ministry of Education, Culture, Sports, Science and Technology, Japan', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Tomoshige Hayashi', 'investigatorAffiliation': 'Osaka Metropolitan University'}}}}