Osaka Cardiometabolic Epidemiological Study: Ohtori Study Part 2 (OCES-2)

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.

Study Overview

• Status: Recruiting
• Conditions: Hyperglycemia; Hypertension; Obesity; Diabetes Mellitus; Atherosclerosis; Metabolic Syndrome; Type 2 Diabetes; Dyslipidemia; Hepatic Steatosis; Insulin Sensitivity/Resistance; Hyperlipidemia; Obesity, Abdominal; Type 2 Diabetes Mellitus (T2DM); Visceral Fat; Central Obesity; Hyperuricemia or Gout; Obesity/Epidemiology; Chronic Kidney Disease(CKD); Hyperuricemia, Gout

Detailed Description

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.

Although 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.

It 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.

In 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.

The 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.

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Tomoshige Hayashi, MD, PhD; Phone Number: 81-6-6645-3751; Email: thayashi@omu.ac.jp
• Study Contact Backup: Name: Kyoko Sato, MD, PhD; Phone Number: 81-6-6645-3751; Email: ksato@omu.ac.jp

Study Locations

• Japan
  • Osaka
    • Sakai, Osaka, Japan, 5938324
      • Recruiting
      • The Ohtori Health Promotion Center
      • Contact: Yonezo Hikita, MD, PhD; Email: ocespart2@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

Inclusion Criteria:

-

Exclusion Criteria:

• Women who may be pregnant

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: Abdominal obesity (waist circumference):Men: ≥90 cm Women: ≥80 cm; Elevated triglycerides:Triglycerides ≥150 mg/dL, or receiving treatment for elevated triglycerides.; Low HDL cholesterol:Men: <40 mg/dL Women: <50 mg/dL, or receiving treatment for low HDL cholesterol.; Elevated blood pressure:Systolic blood pressure ≥130 mmHg, diastolic blood pressure ≥85 mmHg, or receiving antihypertensive treatment.; 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.

Collaborators and Investigators

• Sponsor: Osaka Metropolitan University
• Collaborators: The Ministry of Education, Culture, Sports, Science and Technology, Japan
• Investigators: Principal Investigator: Tomoshige Hayashi, MD, PhD, Osaka Metropolitan University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Estimated): March 31, 2050
• Study Completion (Estimated): March 31, 2050

Study Registration Dates

• First Submitted: November 15, 2024
• First Submitted That Met QC Criteria: November 15, 2024
• First Posted (Actual): November 19, 2024

Study Record Updates

• Last Update Posted (Estimated): December 4, 2024
• Last Update Submitted That Met QC Criteria: November 29, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Dyslipidemia; Hypertension; obesity; Insulin Resistance; Metabolic Syndrome; Chronic Kidney Disease; Japanese; Hyperlipidemia; Insulin Sensitivity; Hyperuricemia; Type 2 Diabetes Mellitus; Visceral fat; Abdominal obesity; Visceral adiposity
• Additional Relevant MeSH Terms: Crystal Arthropathies; Urogenital Diseases; Endocrine System Diseases; Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Nutrition Disorders; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Arthritis; Joint Diseases; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Metabolic Diseases; Overnutrition; Body Weight; Immune System Diseases; Digestive System Diseases; Glucose Metabolism Disorders; Liver Diseases; Renal Insufficiency; Hyperinsulinism; Overweight; Lipid Metabolism Disorders; Arteriosclerosis; Arterial Occlusive Diseases; Gout; Obesity; Hypertension; Diabetes Mellitus, Type 2; Hypersensitivity; Hyperuricemia; Metabolic Syndrome; Diabetes Mellitus; Fatty Liver; Hyperglycemia; Insulin Resistance; Kidney Diseases; Renal Insufficiency, Chronic; Dyslipidemias; Atherosclerosis; Hyperlipidemias; Obesity, Abdominal; Hyperlipoproteinemias
• Other Study ID Numbers: 2024-030; JP23K17444 (Other Grant/Funding Number: Japan Society for the Promotion of Science)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No