UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050579 |
|---|---|
| Receipt number | R000057307 |
| Scientific Title | Prospective obserbational study of diabetes using new classifications by HLA, SNPs and biomarkers |
| Date of disclosure of the study information | 2023/03/14 |
| Last modified on | 2024/03/17 12:32:48 |
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Basic information
Public title
Prospective obserbational study of diabetes using new classifications by HLA, SNPs and biomarkers
Acronym
Ehime Genome Study
Scientific Title
Prospective obserbational study of diabetes using new classifications by HLA, SNPs and biomarkers
Scientific Title:Acronym
Ehime Genome Study
Region
| Japan |
Condition
Condition
type 1 diabetes mellitus, type 2 diabetes mellitus, metabolic syndrome, cardiovascular diseases, kidney diseases, dementia, sarcopenia, frailty, and periodontal disease
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
| Nephrology | Geriatrics | Obstetrics and Gynecology |
| Laboratory medicine | Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The aim of this study is to investigate new classifications for diabetes defined by HLA, SNPs, islet-specific autoantibodies, C-peptide, and other biomarkers.
Basic objectives2
Others
Basic objectives -Others
The other objective is to clarify the association between the factors of the new classifications and onset of diabetes and its complications, cardiovascular diseases, kidney diseases, dementia, sarcopenia, frailty, and periodontal disease in the prospective study.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Onset or progression of diabetes mellitus, cardiovascular diseases, kidney diseases, dementia, sarcopenia, frailty, and periodontal disease
Key secondary outcomes
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) About 2500 patients with diabetes: inpatients and outpatients in Ehime university hospital and the affiliated hospitals*, and the residents in Toon city (Ehime, Japan) who are participated in the Toon Genome Study**
2) About 2500 participants without diabetes: the residents in Toon city (Ehime, Japan) who are participated in the Toon Genome Study**
* The patients were recruited as a part of the Ehime Study since 1998
** This study commenced in 2009
Key exclusion criteria
1) Patients who do not consent to the study
2) Patients who are judged inappropriate for the study by a doctor
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Haruhiko |
| Middle name | |
| Last name | Osawa |
Organization
Ehime University Graduate School of Medicine
Division name
Diabetes and Molecular Genetics
Zip code
791-0295
Address
454 Shitsukawa, Toon, Ehime, Japan
TEL
089-960-5647
harosawa@m.ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | Haruhiko |
| Middle name | |
| Last name | Osawa |
Organization
Ehime University Graduate School of Medicine
Division name
Diabetes and Molecular Genetics
Zip code
791-0295
Address
454 Shitsukawa, Toon, Ehime, Japan
TEL
089-960-5647
Homepage URL
harosawa@m.ehime-u.ac.jp
Sponsor or person
Institute
Ehime University
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
Ehime University Hospital
Address
454 Shitsukawa, Toon, Ehime, Japan
Tel
089-960-5171
rinri@m.ehime-u.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
| 2023 | Year | 03 | Month | 14 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 22 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The Toon Genome Study has conducted first survey (2009-2012), second survey (2014-2018), third survey (2019-2022) and fourth survey (2024-). This study has planned anual checkup.
Management information
Registered date
| 2023 | Year | 03 | Month | 14 | Day |
Last modified on
| 2024 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057307
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
