Tokyo, July 12 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058434) titled 'An Exploratory Study for the Development of Information Medicine Using Inaudible High-Frequency Sound for Diabetes Treatment' on July 11.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Single blind -participants are blinded Control - Placebo

Primary Sponsor: Institute - National Center of Neurology and Psychiatry

Condition: Condition - Type 2 Diabetes and Prediabetes Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To develop informational environmental medicine using inaudible high-frequency sound for metabolic syndrome including diabetes, we will conduct an exploratory 8-week sound exposure intervention in the daily living environments of patients currently undergoing diabetes treatment. This study aims to identify potential implementation challenges while preliminarily evaluating the effects on blood glucose monitoring as well as on diabetes- and metabolic syndrome-related indicators. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Acoustic information containing high-frequency components beyond the upper limit of the audible range Interventions/Control_2 - Acoustic information with only the high-frequency components removed from the same sound source

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - 1. Individuals diagnosed with type 2 diabetes or prediabetes 2. Individuals who are currently receiving either pharmacotherapy, exercise therapy, or dietary therapy for the above condition 3. Male or female individuals aged 20 years or older and under 90 years Key exclusion criteria - 1. Individuals diagnosed with type 1 diabetes 2. Individuals for whom participation in the study is considered difficult due to dementia, psychiatric disorders, or similar conditions 3. Individuals deemed inappropriate for participation by the attending physician or principal investigator Target Size - 12

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 04 Month 25 Day Date of IRB - 2024 Year 11 Month 07 Day Anticipated trial start date - 2025 Year 05 Month 01 Day Last follow-up date - 2026 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066813

Disclaimer: Curated by HT Syndication.