Risk Factors for Type 2 Diabetes Mellitus With Cognitive Impairment: a Cohort Study

NCT ID: NCT05728567

Last Updated: 2023-02-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 3820 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2032-01-01

Brief Summary

The aim of this study was to analyze the risk factors for the development of type 2 diabetes mellitus (T2DM) with mild cognitive impairment (MCI) and its pathogenesis associated with gut microbiota. A prospective cohort study was conducted to recruit 3820 participants aged 45 years and above who attended health checkups at the checkup center of Linyi City People's Hospital, Shandong Province. A follow-up survey was conducted identifying whether the participant had T2DM as an exposure factor group. Socio-demographic characteristics, blood, urine, and stool samples, lifestyle surveys, dietary status, and neuropsychological tests were collected at baseline and follow-up, exploring the association between clinical characteristics and gut microbiota and the risk for the development of T2DM with MCI.

Detailed Description

The aim of this study was to analyze the risk factors for the development of type 2 diabetes mellitus (T2DM) with mild cognitive impairment (MCI) and its pathogenesis associated with gut microbiota. A prospective cohort study was conducted to recruit 3820 participants aged 45 years and above who attended health checkups at the checkup center of Linyi City People's Hospital, Shandong Province. A follow-up survey was conducted identifying whether the participant had T2DM as an exposure factor group. Socio-demographic characteristics, blood, urine, and stool samples, lifestyle surveys, dietary status, and neuropsychological tests were collected at baseline and follow-up, exploring the association between clinical characteristics and gut microbiota and the risk for the development of T2DM with MCI. Therefore, it is important to explore the factors affecting T2DM with MCI and screen for intervening factors, further elucidate its pathogenesis, and search for specific biological markers of early cognitive impairment in T2DM. This is socially and economically important for screening individuals susceptible to T2DM with MCI so that measures can be taken for early intervention and early treatment to improve the quality of life of patients while reducing medical costs.

Conditions

Diabetes Mellitus, Type 2; Cognitive Dysfunction; Gut Microbiota

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Health control group

The participants without type 2 diabetes (T2DM) and mild cognitive impairment (MCI)

No interventions assigned to this group

T2DM group

The T2DM patients without MCI

whether the participants had T2DM

Intervention Type: OTHER

whether the participants had T2DM

DCI group

The T2DM patients with MCI

whether the participants had T2DM

Intervention Type: OTHER

whether the participants had T2DM

Interventions

whether the participants had T2DM

whether the participants had T2DM

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• ≥ 45 years old;
• no impairments in vision, hearing, language, etc., and can cooperate to complete the questionnaire;
• agree to follow-up.

Exclusion Criteria

• have major systemic diseases, such as malignant tumors;
• have serious mental illnesses.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

IRB00001052-22024

Identifier Type: -

Identifier Source: org_study_id