Clinical Trial: Yamanashi Multi-omics Cohort (YMoC) Study for Simulation of Human Metabolic States (Japan)

Tokyo, May 13 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061518) titled 'Yamanashi Multi-omics Cohort (YMoC) Study for Simulation of Human Metabolic States' on May 11.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - University of Yamanashi

Condition: Condition - Prediabetes, Healthy individuals Classification by malignancy - Others Genomic information - YES

Objective: Narrative objectives1 - In this study, we focus on insulin resistance, a key factor underlying metabolic deterioration. By longitudinally collecting omics data and lifestyle information from individuals with mild glucose intolerance, we aim to characterize the progression of metabolic adaptations that underlie the development of lifestyle-related diseases and to identify biological markers and lifestyle factors associated with their regulation. In a preceding study entitled "A multi-omics cohort study to identify metabolic transitions underlying the development of lifestyle-related diseases," integrated analyses of longitudinal proteomics and lifestyle data suggested associations between changes in insulin resistance and several candidate plasma proteins as well as lifestyle-related factors. In addition, the use of wearable devices and smartphone applications enabled the collection of behavioral data and demonstrated the feasibility of analyzing relationships between daily behaviors, such as physical activity and sleep, and metabolism-related proteins. The primary objective of the present study is to validate these findings in an independent cohort population. Specifically, we will longitudinally collect omics data, including plasma proteomics, together with lifestyle data among individuals with mild glucose intolerance to examine the reproducibility of biomolecules and lifestyle behaviors associated with changes in insulin resistance and to analyze the progression of metabolic states. In addition, this study includes an intervention component using the smartphone application Taohealth to support lifestyle improvement. The application provides AI-based health behavior advice based on questionnaire responses and wearable-derived data on physical activity and sleep. These data will be used to analyze relationships between lifestyle behavior changes and metabolic indicators and to exploratorily evaluate the effects of lifestyle interventions on metabolic states. Basic objectives2 - Others

Intervention: Interventions/Control_1 - AI feedback from Taohealth App

Eligibility: Age-lower limit - 25 years-old = Gender - Male and Female Key inclusion criteria - Individuals who underwent a comprehensive health check-up or periodic health examination between fiscal years 2024 and 2026 and meet the following criteria will be eligible for inclusion. 1. The age at the time of examination is between 25 and 70 years, inclusive. 2. The fasting plasma glucose level at the time of examination is 100 mg/dL or higher and 125 mg/dL or lower. 3. The HbA1c level at the time of examination is less than 6.5%. 4. Based on the questionnaire at the time of examination, the individual reports not taking any medication for type 2 diabetes. 5. Written informed consent for participation in this study has been obtained. Key exclusion criteria - Individuals who meet any of the following criteria will be excluded from the study. 1. Individuals who are considered unable to adequately understand the study explanation due to cognitive impairment, severe psychiatric disorders, serious physical illness, or other similar conditions, or who are judged to have difficulty participating in the study or undergoing the required examinations. 2. Individuals who do not possess a smartphone. 3. Individuals who are unable to communicate smoothly in Japanese. 4. Individuals who are judged by the principal investigator to have other conditions that make them inappropriate for participation in this study. Target Size - 1012

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 03 Month 31 Day Date of IRB - 2026 Year 04 Month 17 Day Anticipated trial start date - 2026 Year 04 Month 20 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=R000069633

Disclaimer: Curated by HT Syndication.