An observational study in Type 2 Diabetes Mellitus (T2DM), Type 2 Diabetes and Diabetes Mellitus, sponsored by Osaka Metropolitan University. Recruiting at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2024-12-04.
Sponsored by Osaka Metropolitan University · Observational
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.
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.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 300 across 1,741 observational studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Osaka Metropolitan University is the lead sponsor of 6 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Inclusion Criteria:
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Exclusion Criteria:
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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2024 (actual). Primary completion is estimated for Mar 2050, 304 months after the start.
Of 432 non-industry observational studies under Diabetes Mellitus, Type 2, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 96. This study's planned 304 months is above that.
Counting every sponsor, half of 602 studies reached it within 32 months; a quarter within 17 and three quarters within 62.
How these figures are worked out, and which studies are left out of them.
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Osaka Metropolitan University