UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057687 |
|---|---|
| Receipt number | R000065919 |
| Scientific Title | Study on the pathogenesis and progression mechanisms of type 1 diabetes using peripheral blood lymphocytes |
| Date of disclosure of the study information | 2025/04/22 |
| Last modified on | 2025/04/22 21:03:39 |
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Basic information
Public title
Study on the pathogenesis and progression mechanisms of type 1 diabetes using lymphocytes
Acronym
Lymphocyte-based study of type 1 diabetes
Scientific Title
Study on the pathogenesis and progression mechanisms of type 1 diabetes using peripheral blood lymphocytes
Scientific Title:Acronym
Lymphocyte-based study of type 1 diabetes
Region
| Japan |
Condition
Condition
Type 1 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Identification of key genes involved in the immunological pathogenesis and progression of type 1 diabetes
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Activation enhancer regions and autoimmune-related genes in immune cells such as T cells that support the association with the onset and progression of type 1 diabetes
Key secondary outcomes
Association between HLA types and activation enhancer regions and autoimmune-related genes
Association between islet-related autoantibodies and activation enhancer regions and autoimmune-related genes
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Individuals newly diagnosed with type 1 diabetes (including potential misdiagnoses) or those who are positive for islet-related autoantibodies but have not yet developed diabetes and are considered at risk for type 1 diabetes, who are aged 15 years or older at the time of consent/registration.
Key exclusion criteria
Individuals who are positive for islet-related autoantibodies but have diabetes with suspected alternative pathogenesis
Individuals with severe infections or other serious comorbidities
Individuals deemed unsuitable for participation in this study by the principal investigator or co-investigators
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takaaki |
| Middle name | |
| Last name | Murakami |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Diabetes, Endocrinology and Nutrition
Zip code
606-8501
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto, Japan
TEL
075-751-3560
tmurakam@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Hayao |
| Middle name | |
| Last name | Yoshida |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Diabetes, Endocrinology and Nutrition
Zip code
606-8501
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto, Japan
TEL
075-751-3560
Homepage URL
hayayoshi@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Manpei Suzuki Diabetes Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
53 Shogoin-kawahara-cho, Sakyo-ku, Kyoto 606-8507, Japan
Tel
(tel)075-366-7618
ethcom@kuhp.kyoto-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
G1505
Org. issuing International ID_1
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
京都大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 22 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 04 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 04 | Month | 23 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study Design: Genetic analysis study
Prospective / Target Genes: Primarily immune-regulatory genes
Management information
Registered date
| 2025 | Year | 04 | Month | 22 | Day |
Last modified on
| 2025 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065919
