UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036648 |
|---|---|
| Receipt number | R000041747 |
| Scientific Title | Mortality and risk factors for cardiovascular and non-cardiovascular disease in Japanese with impaired glucose metabolism |
| Date of disclosure of the study information | 2019/05/07 |
| Last modified on | 2023/06/05 19:22:11 |
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Basic information
Public title
Mortality and risk factors for cardiovascular and non-cardiovascular disease in Japanese with impaired glucose metabolism
Acronym
The Hiroshima Study on Glucose Metabolism and Cardiovascular Diseases (Hiroshima GMCVD)
Scientific Title
Mortality and risk factors for cardiovascular and non-cardiovascular disease in Japanese with impaired glucose metabolism
Scientific Title:Acronym
The Hiroshima Study on Glucose Metabolism and Cardiovascular Diseases (Hiroshima GMCVD)
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Hypertension
Cardiovascular disease
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the present study is;
To investigate the long-term prognosis in Japanese with impaired glucose metabolism.
To evaluate the impacts of risk factors such as high blood pressure, dyslipidemia, hyperuricemia, insulin resistance, and beta-cell function on the prognosis in Japanese with impaired glucose metabolism.
To assess the inter-relationship among risk factors for cardiovascular disease.
Basic objectives2
Others
Basic objectives -Others
1.To investigate the cardiovascular and all-cause mortality of participants dividing those into three groups with impaired fasting glucose (IFG), impaired glucose tolerance (IGT), and diabetes.
2.To investigate the impacts of cardiovascular risk factors including hypertension, dyslipidemia, hyperuricemia, insulin resistance and beta-cell function on the cardiovascular and all-cause mortality of participants dividing those into three groups with IFG, IGT, and diabetes.
3.To compare the incidence of hypertension in participants dividing those into three groups with IFG, IGT, and diabetes.
4.To investigate the incidence of diabetes in participants with IFG, and IGT.
5.To compare the tendency to have insulin resistance in hypertensive and normotensive.
6.To investigate the role of impaired glucose metabolism in other cardiovascular comorbidities.
7.To investigate the association between cardiovascular risk factors and beta-cell function.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
All-cause and cardiovascular death
Key secondary outcomes
1.Incidence of diabetes
2.Incidence of hypertension
3.Renal dysfunction
4.Proteinuria
5.Atrial fibrillation
6.Dyslipidemia
7.Hyperuricemia
8.White matter lesions
9.Common carotid artery measurements
10.Serum N-terminal pro B-type natriuretic peptide level
11.Cardio-ankle vascular index
12.Ankle-brachial index
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
| 36 | years-old | <= |
Age-upper limit
| 92 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Participants were recruited after undergoing general health examinations at the Health Management and Promotion Center of the Hiroshima Atomic Bomb Casualty Council.
2.They agreed to undergo the 75-g oral glucose tolerance test.
Key exclusion criteria
Participants were on treatment for type 1 or type 2 diabetes.
Target sample size
19248
Research contact person
Name of lead principal investigator
| 1st name | Nobuo |
| Middle name | |
| Last name | Sasaki |
Organization
Hiroshima Atomic Bomb Casualty Council
Division name
Health Management and Promotion Center
Zip code
730-0052
Address
3-8-6, Senda-machi, Naka-ku, Hiroshima
TEL
082-243-2451
n-sasaki@gentaikyo.or.jp
Public contact
Name of contact person
| 1st name | Tomomi |
| Middle name | |
| Last name | Fujita |
Organization
Hiroshima Atomic Bomb Casualty Council
Division name
Health Management and Promotion Center
Zip code
730-0052
Address
3-8-6, Senda-machi, Naka-ku, Hiroshima
TEL
082-243-2451
Homepage URL
t-ikyoku@gentaikyo.or.jp
Sponsor or person
Institute
Hiroshima Atomic Bomb Casualty Council
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hiroshima Atomic Bomb Casualty Council committee
Address
3-8-6, Senda-machi, Naka-ku, Hiroshima
Tel
082-243-2451
y-ueno@gentaikyo.or.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
| 2019 | Year | 05 | Month | 07 | 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
19248
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
Completed
Date of protocol fixation
| 2018 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2019 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Participants were diagnosed as normal glucose tolerance (NGT), IFG, IGT, or diabetes based on the 75-g oral glucose tolerance test (OGTT) between January 1982 and December 2017 at the Health Management and Promotion Center of Hiroshima Atomic Bomb Casualty Council.
Management information
Registered date
| 2019 | Year | 05 | Month | 04 | Day |
Last modified on
| 2023 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041747
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