Tokyo, Sept. 18 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059112) titled 'Elucidation of the protective effect of subcutaneous insulin administration against brain amyloid accumulation' on Sept. 18.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Non-randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - Toho university school of medicine

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

Objective: Narrative objectives1 - Clarifying the relationship with subcutaneous insulin administration and brain Ab accumulation by quantifying brain Ab accumulation in long-term insulin users and non-users using amyloid PET. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Type 2 diabetes treated with subcutaneous insulin injections for more than 10 years Interventions/Control_2 - Patients who have never used subcutaneous insulin injections

Eligibility: Age-lower limit - 65 years-old

Gender - Male and Female Key inclusion criteria - - Patients with type 2 diabetes who was diagnosed for 10 years or more - Patients aged 65 to 90 years - MOCA-J score of 18 to 25 - Patients who have been receiving subcutaneous insulin injections for 10 years or more - Patients who have never received subcutaneous insulin injections - Patients who have provided written consent to participate in the study Key exclusion criteria - - Patients who have been previously diagnosed with dementia - Patients with underlying conditions that cause cognitive impairment - Heavy alcohol users - Patients taking medications that affect cognitive function - Patients for whom PET scans are difficult to perform - Patients deemed inappropriate by their attending physician Target Size - 12

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 07 Month 30 Day Anticipated trial start date - 2025 Year 09 Month 19 Day Last follow-up date - 2026 Year 10 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067581

Disclaimer: Curated by HT Syndication.