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临床试验/NCT06066775
NCT06066775招募中不适用

A Prospective Cohort Study on the Associations of Endocrine Glucose & Lipids With Brain Aging-related Conditions in Chinese Men and Women

Shandong Provincial Hospital1 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2023年7月4日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
10,000
试验地点
1
主要终点
number of participants who develop brain aging-related conditions during follow-up

研究概览

简要总结

With aging, brain aging leads to a general decline in cognitive ability, and the prevalence of neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD) increases. The prevalence of abnormal glucose and lipid metabolism also increased with age. The imbalance of glucose and lipid metabolism is closely related to brain aging related conditions and diseases, and the relationship between glucose and lipid metabolism and brain aging has not been fully elucidated.

Phase 1: Baseline investigation (community-based survey) Aims: To investigate whether glucose and lipids are the risk factors for brain aging-related conditions, such as mild cognitive impairment.

Subjects and Methods: A community-based survey will be carried out in 10000 natural population aged >=50 years selected from 10-12 communities stratified according to geographic regions (Ciyao, Huafeng, Dongzhuang, Heshan, Geshi, Jiangji, Gangcheng, Fushan, Dongshu, Sidian, Baxianqiao, and Xiangyin, etc) in Ningyang County, Taian City, Shandong Province. A comprehensive examination including questionnaire (including the MMSE and ADL evaluation for the participants), anthropometric measurements, biochemical analysis will be performed in each study participant. In particular, the investigators randomly selected 1000-2000 participants performing MRI of the brain to evaluate the brain aging related conditions.

Phase 2: Cohort follow-up Aims : To examine glucose and lipids metabolism levels and their changes that modify the risk of brain aging-related conditions.

Subjects and Methods: To recruit and follow all 10000 participants for at least 3-5 years. In particular, all 1000-2000 participants with the baseline MRI examination will perform the MRI examination again for the follow-up.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age >= 50 years old;
  • Gender: males and females;
  • Provide written informed consent;
  • Satisfactory compliance.

排除标准

  • Pregnant or lactating women
  • No history of addiction or neurological, psychiatric, or systemic diseases known to affect cognitive function, including head trauma, subdural hematoma, current depression, and epilepsy
  • Any other condition or major systemic diseases that the investigator feels would interfere with trial participation or evaluation of results.

结局指标

主要结局

number of participants who develop brain aging-related conditions during follow-up

时间窗: 5 years

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Jia-jun Zhao

Principal Investigator

Shandong Provincial Hospital

研究点 (1)

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