Clinical trial NCT06066775: Endocrine Glucose & Lipids Metabolism and Brain Aging: a Longitudinal Study
Official title: A Prospective Cohort Study on the Associations of Endocrine Glucose & Lipids With Brain Aging-related Conditions in Chinese Men and Women
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Brain Aging Related Conditions
Keywords: brain aging
cognition
lipid
glucose
Lead sponsor: Shandong Provincial Hospital
Sponsor class: OTHER_GOV
First posted: 2023-10-04
Enrollment: 10000
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: In phase 1, 10000 individuals selected from 10-12 communities stratified according to geographic regions. Among them, 1000-2000 individuals receive the MRI examination.

In Phase 2, 10000 individuals recruited in phase 2 follow-up. Among them, 1000-2000 individuals with the baseline MRI examination will again receive the MRI examination during the follow-up

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Age \>= 50 years old;
2. Gender: males and females;
3. Provide written informed consent;
4. Satisfactory compliance.

Exclusion Criteria:

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

Primary outcomes:
measure: number of participants who develop brain aging-related conditions during follow-up
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Shandong Provincial Hospital Affiliated to Shandong First Medical University
state: Shandong
Study officials:
affiliation: Shandong Provincial Hospital
name: Jiajun Zhao
role: STUDY_CHAIR
References: