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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036648
Receipt No. 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 2019/08/05

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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
Email n-sasaki@gentaikyo.or.jp

Public contact
Name of contact person
1st name Naomi
Middle name
Last name Yuzono
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
Email n-yuzono@gentaikyo.or.jp

Sponsor
Institute Hiroshima Atomic Bomb Casualty Council
Institute
Department

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
Email r-maeda@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
2019 Year 08 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041747

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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