Osaka Cardiometabolic Epidemiological Study: Ohtori Study Part 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 20 years and older
• All sexes
• Adult, Older adult

Study 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

Conditions

Type 2 Diabetes Mellitus (T2DM), Type 2 Diabetes, Diabetes Mellitus, Hypertension, Hyperglycemia, Hyperlipidemia

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

Medical subject headings

Diabetes Mellitus, Type 2, Diabetes Mellitus, Hypertension, Hyperglycemia, Hyperlipidemias, Dyslipidemias, Hyperuricemia, Gout

What is being measured

The primary outcome is the main question the study is designed to answer.

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.

   Measured: 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.

   Measured: 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).

   Measured: 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.

   Measured: 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.

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

   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.

   Measured: 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.

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

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

   Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted19 Nov 2024
2. Study start1 Nov 2024
3. Primary completion31 Mar 2050 (estimated)
4. Study completion31 Mar 2050 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.