Integrating Systematic Data of Medicine to Explore the Solution for Healthy Aging (ISDHA) Phase 4

Обзор

This project aims to build up the comprehensive health database of geriatric medicine for middle-aged and elderly people in Taiwan.

Подробное описание

This project aims to establish a comprehensive local health database for adults aged 40 and above by integrating clinical data, functional assessments, genomics, metabolomics, and gut microbiome profiles.

The project focuses on validating metabolomic and genetic biomarkers associated with sarcopenia and developing predictive models for early risk identification. Longitudinal multi-omics analyses will be conducted using blood, urine, and fecal samples to explore metabolic dynamics and their links to aging-related conditions. In parallel, the study examines brain health and psychosocial factors, including sleep, resilience, apathy, and loneliness, to better understand their roles in cognitive function and healthy aging.

Through the integration of large-scale health data and advanced analytical approaches, this project aims to support early detection, personalized intervention strategies, and the development of precision healthy aging models.

Первичные конечные точки

• The brain volume of local Taiwanese aged over 40 years old [Срок оценки: one hour]

Вторичные конечные точки (12)

• The actigraphy of local Taiwanese aged over 40 years old [Срок оценки: two weeks]
• The sleep quality questionnaire of local Taiwanese aged over 40 years old [Срок оценки: one day]
• The gut microbiota of local Taiwanese aged over 40 years old [Срок оценки: one day]
• The metabolism of local Taiwanese aged over 40 years old [Срок оценки: one day]
• The metabolism of local Taiwanese aged over 40 years old [Срок оценки: one day]
• The sleep quality questionnaire of local Taiwanese aged over 40 years old [Срок оценки: one day]
• The mental/neurocognitive condition questionnaire of local Taiwanese aged over 40 years old [Срок оценки: one day]
• The mental/neurocognitive condition questionnaire of local Taiwanese aged over 40 years old [Срок оценки: one day]
• The mental/neurocognitive condition questionnaire of local Taiwanese aged over 40 years old [Срок оценки: one day]
• The mental/neurocognitive condition questionnaire of local Taiwanese aged over 40 years old [Срок оценки: one day]
• The mental/neurocognitive condition questionnaire of local Taiwanese aged over 40 years old [Срок оценки: one day]
• The mental/neurocognitive condition questionnaire of local Taiwanese aged over 40 years old [Срок оценки: one day]

Критерии участия

Критерии включения

• Willing to sign a written participant consent form.
• Males or females aged 40 or above who have participated in the "Integrated Systematic Geriatric Medical Information to Explore Solutions for Healthy Aging (Pilot Project)," the "Integrated Systematic Geriatric Medical Information to Explore Solutions for Healthy Aging" master planner, or the "Integrated Systematic Medical Information to Explore Solutions for Healthy Aging" project (not subject to exclusion criteria).
• Males or females aged 40-59 who have participated in health checkups for employees of Chang Gung Memorial Hospital, Formosa Plastics Group, or Chang Gung University.
• Those with a medical record of more than one year at Chang Gung Memorial Hospital.
• Those who have resided in Taiwan for more than 180 days in the past year.

Критерии исключения

• Individuals with severe organ abnormalities, such as: heart failure (NYHA Fc ≥ III), chronic obstructive pulmonary disease (hospitalization/emergency room visit or medication adjustment within the past month due to disease worsening), decompensated cirrhosis, hemodialysis, or currently undergoing cancer treatment.
• Individuals with a history of severe autoimmune diseases.
• Individuals with a preliminary cognitive and mental assessment score of <26 on the Mini-Mental State Examination (MMSE) or ≥5 on the Generalized Depression Scale (GDS).
• Individuals (who agree to undergo brain MRI) who are deemed unsuitable for MRI after evaluation (e.g., those with pacemakers, cochlear implants, or spatial phobia).
• Individuals who have taken antibiotics within the past month.
• Individuals whose hearing, vision, or cognitive impairments affect communication.
• Individuals unable to stand or walk (with a walking aid) or with unsteady gait when walking.
• Those who have undergone follow-up outpatient assessments that may affect cognitive function, including but not limited to stroke, Parkinson's syndrome, Parkinson's dementia, epilepsy, brain tumor, or a history of mental illness such as schizophrenia, severe depression, bipolar disorder, alcohol or drug abuse, or a history of loss of consciousness due to severe head trauma.
• Those currently diagnosed with depression and undergoing treatment.
• Those with a past medical history confirming dementia, depression, etc..
• Those deemed unsuitable by a physician.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Тайвань · 2 центра

• Taipei Chang Gung Memorial Hospital — Taipei
• Taoyuan Chang Gung Memorial Hospital — Taoyuan

Идентификаторы

NCT: NCT07414680 · 202501674B0A3

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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