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Osaka Cardiometabolic Epidemiological Study: Ohtori Study Part 2

NCT ID: NCT06694012

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-01

Study Completion Date

2050-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

* Women who may be pregnant
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

UNKNOWN

Sponsor Role collaborator

Osaka Metropolitan University

OTHER

Sponsor Role lead

Responsible Party

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Tomoshige Hayashi

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tomoshige Hayashi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Osaka Metropolitan University

Locations

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The Ohtori Health Promotion Center

Sakai, Osaka, Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Tomoshige Hayashi, MD, PhD

Role: CONTACT

[email protected]
81-6-6645-3751

Kyoko Sato, MD, PhD

Role: CONTACT

[email protected]
81-6-6645-3751

Facility Contacts

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Yonezo Hikita, MD, PhD

Role: primary

[email protected]

Other Identifiers

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JP23K17444

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2024-030

Identifier Type: -

Identifier Source: org_study_id