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

October 4, 2023 updated by: Jia-jun Zhao, Shandong Provincial Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jiajun Zhao

Study Contact Backup

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250021
        • Recruiting
        • Shandong Provincial Hospital Affiliated to Shandong First Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of participants who develop brain aging-related conditions during follow-up
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong Provincial Hospital

Investigators

  • Study Chair: Jiajun Zhao, Shandong Provincial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 4, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2033

Study Registration Dates

First Submitted

September 27, 2023

First Submitted That Met QC Criteria

September 27, 2023

First Posted (Actual)

October 4, 2023

Study Record Updates

Last Update Posted (Actual)

October 6, 2023

Last Update Submitted That Met QC Criteria

October 4, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20230907

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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