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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes Mellitus, Type 2, Cognitive Dysfunction, Gut Microbiota

Intervention / Treatment
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* Other: whether the participants had T2DM


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Health control group<br>The participants without type 2 diabetes (T2DM) and mild cognitive impairment (MCI) | |
| T2DM group<br>The T2DM patients without MCI | Other: whether the participants had T2DM<br>* whether the participants had T2DM<br>|
| DCI group<br>The T2DM patients with MCI | Other: whether the participants had T2DM<br>* whether the participants had T2DM<br>|

What is the study measuring?
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Primary Outcome Measures

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