UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059775 |
|---|---|
| Receipt number | R000065015 |
| Scientific Title | Research for novel markers reflecting pancreatic beta-cell disorders. |
| Date of disclosure of the study information | 2026/08/31 |
| Last modified on | 2025/11/14 12:06:27 |
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Basic information
Public title
Research for novel markers reflecting pancreatic beta-cell disorders.
Acronym
Research for novel markers reflecting pancreatic beta-cell disorders.
Scientific Title
Research for novel markers reflecting pancreatic beta-cell disorders.
Scientific Title:Acronym
Research for novel markers reflecting pancreatic beta-cell disorders.
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Identifying markers that more accurately reflect pancreatic b-cell disorders by using patients with type 1 diabetes as a stepping stone to a more predictable prognosis of b-cell function, which is a current challenge.
Basic objectives2
Others
Basic objectives -Others
none
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of candidate markers (CHGA, IL-21, cytokine) in type 1 diabetes,typye 2 diabetes and healthy subjects.
Key secondary outcomes
Decrease in C-peptide index (CPR/blood glucose) and correlation with candidate markers.
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Selection criteria:
1) Islet-associated autoantibody-positive diabetic patients between 18 and 80 years of age and those with normal glucose tolerance, patients with type 2 diabetes attending our hospital.
1-A) Normal glucose-tolerant patients are those with fasting blood glucose <110 mg/dl or HbA1c <6.2% at a check-up within the past year, recruited on the hospital website.
2) Persons judged by the attending physician to be able to tolerate the glucagon tolerance test
3) Persons who do not meet the following exclusion criteria
Key exclusion criteria
Exclusion criteria:
1) Persons strongly suspected of suffering from dementia or psychiatric disorders
2) Patients with severe renal or hepatic dysfunction
3) Persons who are allergic to glucagon
4) Persons deemed unsuitable for this clinical study by the principal investigator or research assistant.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Hamamoto |
Organization
Kansai Electric Power Medical Research Institute
Division name
Yutaka Seino Distinguished Center forDiabetes Research
Zip code
553-0003
Address
2-1-7 Fukushima, Fukushima-ku Osaka
TEL
06-6458-5821
hamamoto.kitanohosp@gmail.com
Public contact
Name of contact person
| 1st name | Ryota |
| Middle name | |
| Last name | Usui |
Organization
Kansai Electric Power Medical Research Institute
Division name
Yutaka Seino Distinguished Center forDiabetes Research
Zip code
553-0003
Address
2-1-7 Fukushima, Fukushima-ku Osaka
TEL
06-6458-5821
Homepage URL
usui.ryota@a5.kepco.co.jp
Sponsor or person
Institute
Kansai Electric Power Medical Research Institute
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kansai Electric Power Hospital
Address
2-1-7 Fukushima, Fukushima-ku Osaka
Tel
06-6458-5821
masuzaki.seiji@d5.kepco.co.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
| 2026 | Year | 08 | Month | 31 | 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
| 2024 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 12 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
For diabetic patients, after obtaining research consent:
1) Collect blood samples (biochemistry, candidate biomarkers) and perform a glucagon challenge test.
2) Measure fasting blood glucose and C-peptide levels every 3 months.
3) For eligible patients, perform a glucagon challenge test every 12 months to evaluate insulin secretion and collect candidate biomarkers.
4) The above will be followed up for a maximum of 2 years.
For healthy subjects, after obtaining informed consent to participate in the study,1) Blood samples (biochemistry, candidate biomarkers) will be collected, and a glucagon challenge test will be performed.
Management information
Registered date
| 2025 | Year | 11 | Month | 14 | Day |
Last modified on
| 2025 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065015
