Osaka Cardiometabolic Epidemiological Study: Ohtori Study Part 2

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20+
SponsorOsaka Metropolitan University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Women who may be pregnant

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Type 2 diabetes is diagnosed based on the results of a fasting blood glucose test and medication history.

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.

Time frame
Investigators plan to conduct follow-up examinations at intervals of one to two years.
2

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

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.

Time frame
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.
3

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

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).

Time frame
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.
4

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

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.

Time frame
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.

Secondary outcomes

Other outcomes

Sponsors and contacts

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Osaka Metropolitan University

Lead sponsor

The Ministry of Education, Culture, Sports, Science and Technology, Japan

Collaborator