UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058111 |
|---|---|
| Receipt number | R000066416 |
| Scientific Title | Changes in proinsulin levels over time in patients with diabetes. |
| Date of disclosure of the study information | 2025/06/08 |
| Last modified on | 2025/06/06 20:51:11 |
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Basic information
Public title
Changes in proinsulin levels over time in patients with diabetes.
Acronym
Changes in proinsulin levels over time in patients with diabetes.
Scientific Title
Changes in proinsulin levels over time in patients with diabetes.
Scientific Title:Acronym
Changes in proinsulin levels over time in patients with diabetes.
Region
| Japan |
Condition
Condition
Type 1 diabetes, Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to compare changes in proinsulin levels over time in patients with type 1 diabetes (including acute-onset, fulminant and slow-progression types), type 2 diabetes and healthy subjects, in order to clarify the transition of proinsulin levels over time in patients with FT1D and its role in pathogenesis.
Basic objectives2
Others
Basic objectives -Others
Observation of natural progress
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
proinsulin
Key secondary outcomes
Blood glucose, C-peptide, insulin, islet-associated autoantibodies, TSH, FT4
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
| 16 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Patients who are either outpatients or inpatients at the hospital.
(2) Consent to participate in the research has been obtained.
Key exclusion criteria
Patients for whom the onset time is not documented in the medical record.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Norio |
| Middle name | |
| Last name | Kanatuna |
Organization
Osaka Medical and Pharmaceutical University
Division name
Department of Internal Medicine 1
Zip code
569-8686
Address
2-7 Daigaku-machi, Takatsuki, Osaka, Japan
TEL
072-683-1221
naika1hp@ompu.ac.jp
Public contact
Name of contact person
| 1st name | Shohei |
| Middle name | |
| Last name | Kato |
Organization
Osaka Medical and Pharmaceutical University
Division name
Department of Internal Medicine 1
Zip code
569-8686
Address
2-7 Daigaku-machi, Takatsuki, Osaka, Japan
TEL
072-683-1221
Homepage URL
naika1hp@ompu.ac.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Medical and Pharmaceutical University Research Ethics Committee
Address
2-7 Daigaku-machi, Takatsuki, Osaka, Japan
Tel
072-683-1221
rinri@ompu.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
大阪医科薬科大学病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 08 | 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 | 05 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2030 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Blood samples will be collected from patients with type 1 diabetes (including acute-onset, fulminant, and slow-progression types), type 2 diabetes, and healthy subjects attending our hospital to measure proinsulin. Blood glucose, C-peptide, insulin, GAD antibody, IA-2 antibody, insulin antibody, ZnT antibody, TSH, and FT4 levels will be measured additionally. If these data are collected during a routine medical examination, they will be used. The duration of diabetes mellitus will be determined from medical records and interviews.
Management information
Registered date
| 2025 | Year | 06 | Month | 06 | Day |
Last modified on
| 2025 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066416
