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

February 6, 2023 updated by: Peking University
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

3820

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Health control group
The participants without type 2 diabetes (T2DM) and mild cognitive impairment (MCI)
T2DM group
The T2DM patients without MCI
Other: whether the participants had T2DM
whether the participants had T2DM
DCI group
The T2DM patients with MCI
Other: whether the participants had T2DM
whether the participants had T2DM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months
Inflammatory factors
Time Frame: 3 months
IL-6, IL-8, IL-10, IL-18, IL-1β, MCP-1, CRP, TNF-α, IFN-γ
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

December 31, 2020

Study Completion (Anticipated)

January 1, 2032

Study Registration Dates

First Submitted

February 6, 2023

First Submitted That Met QC Criteria

February 6, 2023

First Posted (Actual)

February 15, 2023

Study Record Updates

Last Update Posted (Actual)

February 15, 2023

Last Update Submitted That Met QC Criteria

February 6, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00001052-22024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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