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

Sponsor
Shandong Provincial Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT06066775
Collaborator
(none)
10,000
1
124.9
80

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Observation study without intervention

Study Design

Study Type:
Observational
Anticipated Enrollment :
10000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Prospective Cohort Study on the Associations of Endocrine Glucose & Lipids With Brain Aging-related Conditions in Chinese Men and Women
Actual Study Start Date :
Jul 4, 2023
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2033

Outcome Measures

Primary Outcome Measures

  1. number of participants who develop brain aging-related conditions during follow-up [5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shandong Provincial Hospital Affiliated to Shandong First Medical University Jinan Shandong China 250021

Sponsors and Collaborators

  • Shandong Provincial Hospital

Investigators

  • Study Chair: Jiajun Zhao, Shandong Provincial Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jia-jun Zhao, Principal Investigator, Shandong Provincial Hospital
ClinicalTrials.gov Identifier:
NCT06066775
Other Study ID Numbers:
  • 20230907
First Posted:
Oct 4, 2023
Last Update Posted:
Oct 6, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jia-jun Zhao, Principal Investigator, Shandong Provincial Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 6, 2023