Clinical trial NCT06694012: Osaka Cardiometabolic Epidemiological Study: Ohtori Study Part 2
Official title: Osaka Cardiometabolic Epidemiological Study: Ohtori Study Part 2
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Osaka Metropolitan University
Sponsor class: OTHER
Collaborators: name: The Ministry of Education, Culture, Sports, Science and Technology, Japan
First posted: 2024-11-19
Enrollment: 2000
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

* Women who may be pregnant

Primary outcomes:
measure: Type 2 diabetes is diagnosed based on the results of a fasting blood glucose test and medication history.
timeFrame: Investigators plan to conduct follow-up examinations at intervals of one to two years.
measure: Hypertension is diagnosed based on the results of blood pressure measurement and medication history.
timeFrame: 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.
measure: Dyslipidemia is diagnosed based on the National Cholesterol Education Program (NCEP) Adult Treatment Panel III guidelines.
timeFrame: 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.
measure: Metabolic syndrome is diagnosed based on the Joint Interim Statement published in Circulation. 2009 Oct 20;120(16):1640-5.
timeFrame: 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.
measure: Hyperuricemia is defined based on fasting serum uric acid levels and the use of oral medication.
timeFrame: 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.
measure: Low eGFR was define based on the Modification of Diet in Renal Disease study equation for Japanese.
timeFrame: 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:
Locations:
city: Sakai
country: Japan
facility: The Ohtori Health Promotion Center
state: Osaka
Study officials:
affiliation: Osaka Metropolitan University
name: Tomoshige Hayashi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: