UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062371 |
|---|---|
| Receipt number | R000071382 |
| Scientific Title | Development of an Amylin Detection Method in Human Pancreatic Tissue and Its Correlation with Diabetes Severity |
| Date of disclosure of the study information | 2026/08/01 |
| Last modified on | 2026/07/28 16:55:35 |
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Basic information
Public title
Development of an Amylin Detection Method in Human Pancreatic Tissue and Its Correlation with Diabetes Severity
Acronym
Pancreatic Amylin Detection and diabetes Severity study
Scientific Title
Development of an Amylin Detection Method in Human Pancreatic Tissue and Its Correlation with Diabetes Severity
Scientific Title:Acronym
Pancreatic Amylin Detection and diabetes Severity study
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish an IAPP seed amplification assay (IAPP-SAA) that sensitively detects amylin (islet amyloid polypeptide, IAPP) aggregates in human pancreatic tissue by applying the principle of micelle-assisted SAA (mSAA). In addition, to compare IAPP seeding activity between patients with type 2 diabetes and those with normal glucose tolerance, and to clarify the associations of IAPP aggregates with diabetes severity (disease duration, HbA1c, serum C-peptide and other indices of insulin secretory capacity), pancreatic beta-cell function, and islet amyloid deposition.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The amount of protein aggregates generated after a fixed reaction time when pancreatic and blood specimens are mixed with normal (monomeric) IAPP substrate, i.e., IAPP seeding activity measured by IAPP-SAA.
Key secondary outcomes
Levels of normal (monomeric) IAPP and oligomeric IAPP in pancreatic and blood specimens (quantified by ELISA, etc.). IAPP deposition, islet amyloid deposition, and insulin-positive area (an index of residual beta-cell mass) evaluated by immunohistochemistry and related staining of pancreatic tissue sections. Correlations between the amount of protein aggregates and indices of diabetes severity/insulin secretory capacity, including HbA1c, serum C-peptide, and diabetes duration. Correlations between the amount of protein aggregates and the amount, morphology, and components of the peri-islet vascular endothelial glycocalyx.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients aged 18 years or older with type 2 diabetes or normal glucose tolerance. 2. Patients scheduled to undergo pancreatectomy between the date of approval and March 31, 2029. 3. Patients from whom written informed consent to participate in this study can be obtained.
Key exclusion criteria
1. Patients with types of diabetes other than type 2 diabetes. 2. Patients judged by the physician to be inappropriate as study subjects for other reasons. 3. Patients who have declined the use of their information by submitting a consent withdrawal form.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shin |
| Middle name | |
| Last name | Tsunekawa |
Organization
Gifu University Graduate School of Medicine
Division name
Department of Diabetes, Endocrinology and Metabolism
Zip code
501-1194
Address
1-1 Yanagido, Gifu city, Gifu
TEL
058-230-6373
tsunekawa.shin.d9@f.gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Takahashi |
Organization
Gifu University Graduate School of Medicine
Division name
Department of Diabetes, Endocrinology and Metabolism
Zip code
501-1194
Address
1-1 Yanagido, Gifu city, Gifu
TEL
058-230-6373
Homepage URL
takahashi.yoshihiro.r9@f.gifu-u.ac.jp
Sponsor or person
Institute
Gifu University
Institute
Department
Personal name
Funding Source
Organization
Gifu University
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
Gifu University Graduate School of Medicine Ethics Review Committee for Medical Research
Address
1-1 Yanagido, Gifu city, Gifu
Tel
058-230-6059
rinri@t.gifu-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
| 2026 | Year | 08 | Month | 01 | 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
| 2026 | Year | 07 | Month | 28 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 24 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 28 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is an observational study using pancreatic tissue and clinical data obtained from patients who undergo pancreatectomy. No additional invasive procedures are performed for research purposes; the study uses a portion of the surplus pancreatic tissue that remains after specimens necessary for pathological diagnosis have been secured from tissue resected in routine clinical care.
Eligible participants are patients aged 18 years or older with type 2 diabetes or normal glucose tolerance who undergo pancreatectomy between the date of approval and March 31, 2029, and from whom written informed consent is obtained. The target sample size is 30 (15 with type 2 diabetes and 15 with normal glucose tolerance).
Using pancreatic tissue extracts, the seeding activity of amylin (islet amyloid polypeptide, IAPP) aggregates is evaluated by an IAPP seed amplification assay (IAPP-SAA) based on the principle of micelle-assisted SAA (mSAA), and the levels of monomeric and oligomeric IAPP are quantified by ELISA. In pancreatic tissue sections, IAPP deposition, islet amyloid deposition, and insulin-positive area (an index of residual beta-cell mass) are assessed by IAPP immunostaining, Congo red staining, and insulin staining. In addition, the amount, morphology, and components of the peri-islet vascular endothelial glycocalyx are evaluated using frozen sections prepared from the same specimens by special staining and electron microscopy.
These measurements are compared between the type 2 diabetes group and the normal glucose tolerance group, and their associations with clinical information collected from medical records (indices of insulin secretory capacity and diabetes severity, such as diabetes duration, HbA1c, and serum C-peptide) are analyzed in an exploratory manner. All items obtained from medical records are those performed in routine clinical care. This is an exploratory cohort study for which no sample size was set in advance.
Management information
Registered date
| 2026 | Year | 07 | Month | 28 | Day |
Last modified on
| 2026 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071382
