Clinical trial NCT05728567: Risk Factors for Type 2 Diabetes Mellitus With Cognitive Impairment: a Cohort Study
Official title: Risk Factors for Type 2 Diabetes Mellitus With Cognitive Impairment: a Cohort Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Diabetes Mellitus, Type 2
Cognitive Dysfunction
Gut Microbiota
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2023-02-15
Enrollment: 3820
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participants aged 45 years and above who attended health checkups at the checkup center of Linyi City People's Hospital, Shandong Province, were recruited in this study.

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.

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.

Primary outcomes:
measure: Gut microbiota
timeFrame: 3 months
measure: Inflammatory factors
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
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