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

Active, not recruiting

• Conditions: Cognitive Dysfunction; Gut Microbiota; Diabetes Mellitus, Type 2
• Interventions: Other: whether the participants had T2DM

• Registration Number: NCT05728567
• Lead Sponsor: Peking University

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.

Study Timeline

• Study Start: 2017-01-01
• Primary Completion: 2020-12-31
• Status Verified: 2023-02
• Study First Submitted: 2023-02-06
• Study First Submitted QC: 2023-02-06
• Last Update Submitted: 2023-02-06
• Study First Posted: 2023-02-15
• Last Update Posted: 2023-02-15
• Study Completion: 2032-01-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 3820

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
T2DM group	whether the participants had T2DM	The T2DM patients without MCI
DCI group	whether the participants had T2DM	The T2DM patients with MCI

Primary Outcome Measures

Name	Time	Method
Gut microbiota	3 months	The gut microbiota comprises trillions of symbioticmicroorganisms, whose alterations impact not only gut diseasesbut also central nervous system (CNS) disorders.
Inflammatory factors	3 months	IL-6, IL-8, IL-10, IL-18, IL-1β, MCP-1, CRP, TNF-α, IFN-γ