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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05728567
• Other study ID #: IRB00001052-22024
• Status: Active, not recruiting
• Start date: January 1, 2017
• Est. completion date: January 1, 2032

Study information

• Verified date: February 2023
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3820
• Est. completion date: January 1, 2032
• Est. primary completion date: December 31, 2020
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Other:
• whether the participants had T2DM
whether the participants had T2DM

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gut microbiota	The gut microbiota comprises trillions of symbioticmicroorganisms, whose alterations impact not only gut diseasesbut also central nervous system (CNS) disorders.	3 months
Primary	Inflammatory factors	IL-6, IL-8, IL-10, IL-18, IL-1ß, MCP-1, CRP, TNF-a, IFN-?	3 months