Risk Factors for Type 2 Diabetes Mellit… | Clinical Trial

Key information

Conditions

Diabetes Mellitus, Type 2 Cognition Disorders Cognitive Dysfunction Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Gut Microbiota Mental Disorders Metabolic Diseases Neurocognitive Disorders Nutritional and Metabolic Diseases

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

whether the participants had T2DM

Other

whether the participants had T2DM

Primary outcomes

Gut microbiota

Time frame: 3 months

The gut microbiota comprises trillions of symbioticmicroorganisms, whose alterations impact not only gut diseasesbut also central nervous system (CNS) disorders.
Inflammatory factors

Time frame: 3 months

IL-6, IL-8, IL-10, IL-18, IL-1β, MCP-1, CRP, TNF-α, IFN-γ

Sponsors and collaborators

Lead sponsor

Peking University

Other

Registry information

Important dates

Study start: 2017
Primary completion: 2020
Study completion: 2032
First posted: Feb 15, 2023
Registry last updated: Feb 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed