Tokyo, Aug. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062371) titled 'Development of an Amylin Detection Method in Human Pancreatic Tissue and Its Correlation with Diabetes Severity' on Aug. 1.

Study Type: Observational

Primary Sponsor: Institute - Gifu University

Condition: Condition - Type 2 diabetes Classification by malignancy - Others Genomic information - NO

Objective: 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

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 Size - 30

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071382

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