Osaka Cardiometabolic Epidemiological Study: Ohtori Study Part 2

NCT06694012 | Recruiting

• 2 other identifiers: 2024-030JP23K17444
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

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

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

Outcome Measures

Primary Outcomes (6)

• 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.

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

• 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.

  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 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).

  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.

• 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.

  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 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.

  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 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.

  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.

Eligibility Criteria

• Age: 20 Years+
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may not qualify if:

• Women who may be pregnant

Sponsors & Collaborators

• Osaka Metropolitan University: lead
• The Ministry of Education, Culture, Sports, Science and Technology, Japan: collaborator

Study Sites (1)

The Ohtori Health Promotion Center

Sakai, Osaka, 5938324, Japan

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples stored in serum.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Hypertension; Hyperglycemia; Hyperlipidemias; Dyslipidemias; Hyperuricemia; Gout; Obesity; Obesity, Abdominal; Renal Insufficiency, Chronic; Atherosclerosis; Metabolic Syndrome; Fatty Liver; Insulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Lipid Metabolism Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Arteriosclerosis; Arterial Occlusive Diseases; Hyperinsulinism; Liver Diseases; Digestive System Diseases

Study Officials

• Tomoshige Hayashi, MD, PhD

  Osaka Metropolitan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tomoshige Hayashi, MD, PhD

CONTACT

81-6-6645-3751; thayashi@omu.ac.jp

Kyoko Sato, MD, PhD

CONTACT

81-6-6645-3751; ksato@omu.ac.jp

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: November 19, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): March 31, 2050
• Study Completion (Estimated): March 31, 2050
• Last Updated: December 4, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)