China Diabetes Cognitive Dysfunction Early Diagnosis and Intervention Study (China-DECODE Study)
1 other identifier
observational
10,000
1 country
1
Brief Summary
Type 2 diabetes (T2D) and dementia are both diseases with increasing incidence and prevalence globally, leading to substantial economic burdens for families and society. Notably, diabetes significantly increases the risk of cognitive dysfunction, which is classified into preclinical stage, mild cognitive impairment and dementia based on the disease severity. Cognitive dysfunction is a critical contributor to disability and mortality in elderly diabetes patients. Early diagnosis and intervention are crucial for delaying disease progression, enhancing treatment efficacy, and mitigating the impact of dementia. Currently, research and clinical management of cognitive dysfunction in individuals with diabetes are in their infancy, characterized by limitations such as single-center studies, limited sample sizes, inconsistent diagnostic criteria, and insufficient data sharing. Consequently, clinical diagnosis and treatment strategies are underdeveloped, medical staff's related knowledge is lacking, and potential therapeutic targets remain unexplored. In view of these problems and shortcomings, the population cohort study is supposed to be carried out based on accurate diagnosis and constructed the high standard information and sample bank. The study will establish the standard and quality system of T2D with cognitive dysfunction cohort study (unified standards and norms). The study will integrate the standard biological samples stratified acquisition function module (homogeneity and precision) of cognitive dysfunction in T2D, and complete the construction of biological samples bank and clinical diagnosis and treatment information database. The study will apply and develop brain structural and functional imaging technology to support precision diagnosis of cognitive dysfunction in T2D.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 15, 2024
CompletedFirst Posted
Study publicly available on registry
October 21, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2034
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2034
October 21, 2024
October 1, 2024
18 years
October 15, 2024
October 18, 2024
Conditions
Outcome Measures
Primary Outcomes (4)
Prevalence, incidence of cognitive dysfunction in type 2 diabetes
Prevalence, incidence of mild cognitive impairment in type 2 diabetes
From 2016 to 2034
Risk factors for cognitive dysfunction in type 2 diabetes, such as diabetes duration, poor glycemic control, hypertension, obesity, dyslipidemia, and active inflammation, et al.
Risk factors for the occurrence and progression of mild cognitive impairment in type 2 diabetes, such as diabetes duration, poor glycemic control, hypertension, obesity, dyslipidemia, and active inflammation, et al.
From 2016 to 2034
Biomarkers of cognitive dysfunction in type 2 diabetes
Diagnostic biomarkers, predictive biomarkers, and prognostic biomarkers of cognitive dysfunction in type 2 diabetes
From 2016 to 2034
Glycemic control targets for cognitive dysfunction in type 2 diabetes
Glycemic control targets (including glycated hemoglobin, glycemic fluctuations and hypoglycemic events) for slowing or reversing disease progression of cognitive dysfunction in type 2 diabetes.
From 2016 to 2034
Interventions
Naturalistic observation
Eligibility Criteria
This study is a dynamic prospective cohort study.
You may qualify if:
- Age ≥45 years;
- Type 2 diabetes diagnosed according to the American Diabetes Association criteria;
- Willingness and ability to complete systematic neuropsychological tests;
- Understanding of the research procedures and methods, potential benefits and risks of the trial, and sign written informed consent.
You may not qualify if:
- Fewer than 6 years of education;
- Left-handedness;
- Dementia;
- Acute metabolic complications such as diabetic ketoacidosis, hyperglycaemic hyperosmolar state and hypoglycaemic coma within the previous 3 months;
- History or presence of neurological or psychiatric disorders;
- Presence of hypothyroidism;
- History of malignancy, or severe kidney or liver dysfunction.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Endocrinology, Endocrine and Metabolic Disease Medical Center, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
Nanjing, Jiangsu, 210008, China
Biospecimen
DNA and mRNA
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Yan Bi, M.D., Ph.D.
Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 10 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 15, 2024
First Posted
October 21, 2024
Study Start
October 1, 2016
Primary Completion (Estimated)
October 1, 2034
Study Completion (Estimated)
October 1, 2034
Last Updated
October 21, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share