UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058111 |
|---|---|
| Receipt number | R000066416 |
| Scientific Title | Cross-sectional comparison of serum proinsulin levels by diabetes subtype and disease duration. |
| Date of disclosure of the study information | 2025/06/08 |
| Last modified on | 2025/12/19 20:34:21 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A cross-sectional study comparing serum proinsulin levels in diabetes (type 1 subtypes and type 2) and healthy controls.
Acronym
Proinsulin-CS (OMPU)
Scientific Title
Cross-sectional comparison of serum proinsulin levels by diabetes subtype and disease duration.
Scientific Title:Acronym
Proinsulin-CS (OMPU)
Region
| Japan |
Condition
Condition
Acute-onset type 1 diabetes, fulminant type 1 diabetes, slowly progressive type 1 diabetes, type 2 diabetes (plus healthy controls))
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare serum proinsulin levels across diabetes subtypes (acute-onset, fulminant, slowly progressive type 1 diabetes), type 2 diabetes, and healthy controls in a cross-sectional design with a single blood draw, and to clarify the profile in fulminant type 1 diabetes.
Basic objectives2
Others
Basic objectives -Others
Cross-sectional observational study
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 (GAD Ab, IA-2 Ab, insulin Ab, ZnT8 Ab), TSH, FT4, pancreatic exocrine enzyme (amylase)
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) Outpatients or inpatients at the hospital, or healthy controls
(2) Aged >=16 and <100 years at enrollment
(3) Written informed consent has been obtained (including consent from a legally acceptable representative when applicable)
Key exclusion criteria
(1) Onset time of diabetes is not documented in the medical record
(2) Diagnosed with pancreatic cancer
(3) History of pancreatectomy
(4) Blood glucose <70 mg/dL in the collected sample
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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 05 | Month | 26 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 07 | 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
In this cross-sectional study, a single blood sample will be collected from patients with type 1 diabetes (acute-onset, fulminant, and slowly progressive), type 2 diabetes, and healthy controls to measure serum proinsulin (no longitudinal follow-up sampling). Secondary variables include blood glucose, C-peptide, insulin, islet-associated autoantibodies (GAD, IA-2, insulin, ZnT8), TSH, FT4, and amylase. Routine clinical data will be used when available, and additional measurements will be outsourced when necessary. Clinical information including sex, BMI, age at onset, and disease duration will be extracted from medical records. Healthy control samples may include secondary use of specimens from an IRB-approved study (approval No. 2161).
Management information
Registered date
| 2025 | Year | 06 | Month | 06 | Day |
Last modified on
| 2025 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066416
