Clinical trial

Osaka Cardiometabolic Epidemiological Study: Ohtori Study Part 2

Recruiting now · Not applicable · 1 countries · Registry ID NCT06694012

Recruiting nowNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age20 Years to Not listed

SexAll

Healthy volunteersNot listed

ConditionType 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

Full registry criteria

Inclusion Criteria: \- Exclusion Criteria: * Women who may be pregnant

Treatments and study arms

The registry does not list a named intervention.

Primary outcomes

Type 2 diabetes is diagnosed based on the results of a fasting blood glucose test and medication history.Investigators plan to conduct follow-up examinations at intervals of one to two years.

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.

Hypertension is diagnosed based on the results of blood pressure measurement and medication history.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.

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.

Dyslipidemia is diagnosed based on the National Cholesterol Education Program (NCEP) Adult Treatment Panel III guidelines.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.

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).

Metabolic syndrome is diagnosed based on the Joint Interim Statement published in Circulation. 2009 Oct 20;120(16):1640-5.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.

An individual is diagnosed with metabolic syndrome if they meet three or more of the following criteria: 1. Abdominal obesity (waist circumference): Men: ≥90 cm Women: ≥80 cm 2. Elevated triglycerides: Triglycerides ≥150 mg/dL, or receiving treatment for elevated triglycerides. 3. Low HDL cholesterol: Men: \<40 mg/dL Women: \<50 mg/dL, or receiving treatment for low HDL cholesterol. 4. Elevated blood pressure: Systolic blood pressure ≥130 mmHg, diastolic blood pressure ≥85 mmHg, or receiving antihypertensive treatment. 5. Elevated fasting blood glucose: Fasting blood glucose ≥100 mg/dL, or receiving treatment for elevated blood glucose.

Hyperuricemia is defined based on fasting serum uric acid levels and the use of oral medication.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.

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.

Low eGFR was define based on the Modification of Diet in Renal Disease study equation for Japanese.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.

Low eGFR was defined if eGFR was less than 60 mL/min/1.73 m², regardless of the presence of proteinuria.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

The Ohtori Health Promotion Center🇯🇵 Sakai, Osaka, Japan

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Yonezo Hikita, MD, PhDContact