Actively Recruiting
China Diabetes Cognitive Dysfunction Early Diagnosis and Intervention Study (China-DECODE Study)
Led by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Updated on 2024-10-21
10000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to improve early diagnosis and intervention for cognitive dysfunction in people with type 2 diabetes, a condition linked to increased risk of memory and thinking problems, including dementia. The study addresses current challenges in clinical management, such as inconsistent diagnostic criteria and limited data sharing, by establishing a large population cohort with standardized information and biological samples. It also applies advanced brain imaging techniques to support precise diagnosis of cognitive issues in diabetes. Participants undergo naturalistic observation without experimental treatments. During the screening period, they complete neuropsychological tests and laboratory exams including brain MRI and olfactory function assessments. Biological samples like plasma, serum, urine, and feces are collected to build a high-quality sample bank. The study integrates uniform standards and advanced biological and clinical data collection to better understand cognitive dysfunction in type 2 diabetes. Throughout the study, participants' cognitive function is evaluated using a comprehensive test battery. Researchers collect clinical and biological data to identify prevalence, risk factors, biomarkers, and optimal glycemic control related to cognitive decline in diabetes. The study runs from 2016 to 2034, providing long-term monitoring and data integration to support improved diagnosis and treatment strategies for this population.
CONDITIONS
Brief Title
China Diabetes Cognitive Dysfunction Early Diagnosis and Intervention Study (China-DECODE Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 65 years
- Diagnosed with type 2 diabetes according to American Diabetes Association criteria
- Willingness and ability to complete systematic neuropsychological tests
- Understanding of study procedures, potential benefits and risks, and signing written informed consent
You will not qualify if you...
- Less than 6 years of education
- Left-handedness
- Dementia
- Acute metabolic complications like diabetic ketoacidosis, hyperglycaemic hyperosmolar state, or hypoglycaemic coma within the past 3 months
- History or presence of neurological or psychiatric disorders
- Hypothyroidism
- History of malignancy or severe kidney or liver dysfunction
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From 2016 to 2034
Participants undergo neuropsychological tests, laboratory examinations, brain MRI, olfactory function measurements, and sample collection including plasma, serum, urine, and feces to assess cognitive function.
Periodic visits over the study duration
Duration - From 2016 to 2034
Participants are observed naturally over time to monitor the prevalence, incidence, and risk factors of cognitive dysfunction in type 2 diabetes.
Periodic visits over the study duration
Trial Site Locations
Total: 1 location
1
Department of Endocrinology, Endocrine and Metabolic Disease Medical Center, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
Nanjing, Jiangsu, China, 210008
Actively Recruiting
Research Team
Y
Yan Bi, M.D., Ph.D.
Z
Zhou Zhang, M.D., Ph.D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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