Endocrine Glucose & Lipids Metabolism and Brain Aging: a Longitudinal Study

NCT ID: NCT06066775

Last Updated: 2023-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-04

Study Completion Date

2033-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Brain Aging Related Conditions

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Observation study without intervention

Observation study without intervention

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shandong Provincial Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Jia-jun Zhao

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jiajun Zhao

Role: STUDY_CHAIR

Shandong Provincial Hospital

Locations

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Shandong Provincial Hospital Affiliated to Shandong First Medical University

Jinan, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ling Gao

Role: CONTACT

+8613793187189

Jiajun Zhao

Role: CONTACT

Facility Contacts

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Lijie Wang

Role: primary

+8618253166055

Other Identifiers

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20230907

Identifier Type: -

Identifier Source: org_study_id

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