UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056009 |
|---|---|
| Receipt number | R000063966 |
| Scientific Title | Osaka Cardiometabolic Epidemiological Study: Ohtori Study Part 2 |
| Date of disclosure of the study information | 2024/11/01 |
| Last modified on | 2024/11/12 20:47:55 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Osaka Cardiometabolic Epidemiological Study: Ohtori Study Part 2
Acronym
Ohtori Study Part 2
Scientific Title
Osaka Cardiometabolic Epidemiological Study: Ohtori Study Part 2
Scientific Title:Acronym
Ohtori Study Part 2
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus, Hyperglycemia, Hypertension, Hyperlipidemia, Dyslipidemia, Hyperuricemia/gout, Metabolic syndrome, Obesity, Abdominal obesity, Central obesity, Visceral fat, Hepatic steatosis, Chronic kidney disease, Atherosclerosis
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine risk factors for the development of diabetes and other lifestyle-related diseases in a prospective cohort study.
Basic objectives2
Others
Basic objectives -Others
To investigate risk factors for the development of each cardiometabolic disease
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The prevalence and incidence of cardiometabolic disease, including type 2 diabetes, hypertension, obesity, dyslipidemia, metabolic syndrome, ischemic heart disease, cerebrovascular disease, hyperuricemia, and chronic kidney disease.
Key secondary outcomes
Continuous variables that define each endpoint
Continuous variables that define each risk factor
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy men and women over 20 years old
Key exclusion criteria
Women who may be pregnant
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Tomoshige |
| Middle name | |
| Last name | Hayashi |
Organization
Osaka Metropolitan University
Division name
Preventive Medicine and Environmental Health, Graduate School of Medicine
Zip code
545-8585
Address
1-4-3 Asahi-machi, Abeno-ku, Osaka, Japan
TEL
06-6645-3751
thayashi@omu.ac.jp
Public contact
Name of contact person
| 1st name | Tomoshige |
| Middle name | |
| Last name | Hayashi |
Organization
Osaka Metropolitan University
Division name
Preventive Medicine and Environmental Health, Graduate School of Medicine
Zip code
545-8585
Address
1-4-3 Asahi-machi, Abeno-ku, Osaka, Japan
TEL
06-6645-3751
Homepage URL
thayashi@omu.ac.jp
Sponsor or person
Institute
Osaka Metropolitan University
Institute
Department
Personal name
Tomoshige Hayashi
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology (MEXT)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Ohtori Health Promotion Center
Department of Analytical and Bioinorganic Chemistry, Division of Analytical and Physical Sciences, Kyoto Pharmaceutical University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of Osaka Metropolitan University Graduate School of Medicine
Address
1-2-7 Asahi-machi, Abeno-ku, Osaka, Japan
Tel
06-6645-3456
gr-a-knky-ethics@omu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2024 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2044 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1. Design Details: Prospective Cohort Study
2. Participation Criteria:
a. Eligibility Criteria: No; Exclusion criteria: Women who may be pregnant
b. Ages Eligible for Study: 20-70 years old; Sexes Eligible for Study: All; Accepts Healthy Volunteers: No
3. Sponsor: Osaka Metropolitan University, Collaborators: Ministry of Education, Culture, Sports, Science and Technology, Japan
Principal Investigator: Tomoshige Hayashi, MD, PhD, Osaka Metropolitan University
4. More Information: Conditions and Term related to this study
Type 2 Diabetes Mellitus, Diabetes Mellitus, Hypertension, Metabolic Syndrome, Hyperuricemia, Obesity, Overweight, Central Obesity, Visceral adiposity, Chronic Kidney Disease, Glucose Metabolism Disorders, Metabolic Diseases, Atherosclerosis, Coronary Artery Disease, Stroke
5. Contact Information: Contact information is displayed when the study is recruiting subjects.
6. Recruitment Information: a. Recruitment Status: Active; Study Start Date: 2024-11-1; Eligibility Criteria: no eligibility criteria; Exclusion criteria: women who may be pregnant; Sexes Eligible for the Study: all; Ages: 20-70 years old; Accepts Healthy Volunteers: No
7. Administrative Information: JSPS KAKENHI Grant Number 23K17444; Current Responsible Party: Tomoshige Hayashi, MD, PhD, Osaka Metropolitan University; Current Study Sponsor: Osaka Metropolitan University; Investigators: Principal Investigator: Tomoshige Hayashi, MD, PhD, Osaka Metropolitan University
Brief Summary
We will conduct a prospective cohort study to investigate the association between central obesity and related risk factors and the development of cardiometabolic diseases in a newly recruited cohort of Japanese men and women. We will also investigate novel risk factors for cardiometabolic diseases using molecular weight-based metallomics analysis.
Management information
Registered date
| 2024 | Year | 11 | Month | 01 | Day |
Last modified on
| 2024 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063966
