Type 2 Diabetes Mellitus (T2DM)OCES-2NCT06694012
Osaka Cardiometabolic Epidemiological Study: Ohtori Study Part 2
An observational study of Type 2 Diabetes Mellitus (T2DM) and Type 2 Diabetes, run by Osaka Metropolitan University at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM), Type 2 Diabetes, Diabetes Mellitus
- How many people
- 2,000 participants
- Where
- 1 siteJapan
- Study dates
- 1 Nov 2024to 31 Mar 2050
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- -
Who cannot join
- Women who may be pregnant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Japan1 site, 1 recruiting
- Recruiting
The Ohtori Health Promotion Center
Sakai, Osaka, 5938324
Yonezo Hikita, MD, PhD, ocespart2@gmail.com
About this study
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.
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus (T2DM), Type 2 Diabetes, Diabetes Mellitus, Hypertension, Hyperglycemia, Hyperlipidemia
- 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
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Hypertension, Hyperglycemia, Hyperlipidemias, Dyslipidemias, Hyperuricemia, Gout
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start1 Nov 2024
- Primary completion31 Mar 2050 (estimated)
- Study completion31 Mar 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Osaka Metropolitan University
- Sponsor type
- University, hospital or other
- Collaborators
- The Ministry of Education, Culture, Sports, Science and Technology, Japan
- Responsible party
- Principal investigator, Tomoshige Hayashi, Osaka Metropolitan University
- Investigators
- Tomoshige Hayashi, MD, PhD, Principal investigator, Osaka Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06694012
- Sponsor's protocol ID
- 2024-030
- Other IDs
- JP23K17444
- Acronym
- OCES-2
- Status last verified
- Nov 2024
- First submitted
- 15 Nov 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osaka Cardiometabolic Epidemiological Study: Ohtori Study Part 2
- ClinicalTrials.gov ID
- NCT06694012
- Acronym / sponsor ID
- OCES-2 / 2024-030
- Conditions
- Type 2 Diabetes Mellitus (T2DM), Type 2 Diabetes, Diabetes Mellitus, Hypertension, Hyperglycemia, Hyperlipidemia
- Keywords
- Type 2 Diabetes Mellitus, Hypertension, Hyperlipidemia, Dyslipidemia, Hyperuricemia, obesity, Abdominal obesity, Visceral fat
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Osaka Metropolitan UniversityUniversity, hospital or other
- Collaborators
- The Ministry of Education, Culture, Sports, Science and Technology, Japan
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 31 Mar 2050 (estimated)
- Study completion
- 31 Mar 2050 (estimated)
- First posted
- 19 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (1 listed)
- Women who may be pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Type 2 diabetes is diagnosed based on the results of a fasting blood glucose test and medication history.
Time frame: Investigators plan to conduct follow-up examinations at intervals of one to two years.
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.
Hypertension is diagnosed based on the results of blood pressure measurement and medication history.
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.
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.
Dyslipidemia is diagnosed based on the National Cholesterol Education Program (NCEP) Adult Treatment Panel III guidelines.
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 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).
Metabolic syndrome is diagnosed based on the Joint Interim Statement published in Circulation. 2009 Oct 20;120(16):1640-5.
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.
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.
Hyperuricemia is defined based on fasting serum uric acid levels and the use of oral 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.
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.
Low eGFR was define based on the Modification of Diet in Renal Disease study equation for Japanese.
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 defined if eGFR was less than 60 mL/min/1.73 m², regardless of the presence of proteinuria.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tomoshige Hayashi, MD, PhD principal investigator
Osaka Metropolitan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus (T2DM) and Type 2 Diabetes, run by Osaka Metropolitan University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tomoshige Hayashi, MD, PhD (81-6-6645-3751, thayashi@omu.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Type 2 diabetes is diagnosed based on the results of a fasting blood glucose test and medication history. (time frame: Investigators plan to conduct follow-up examinations at intervals of one to two years.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.