NCT06650969 China Diabetes Cognitive Dysfunction Early Diagnosis and Intervention Study (China-DECODE Study)
| NCT ID | NCT06650969 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School |
| Condition | Type 2 Diabetes |
| Study Type | OBSERVATIONAL |
| Enrollment | 10,000 participants |
| Start Date | 2016-10-01 |
| Primary Completion | 2034-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 10,000 participants in total. It began in 2016-10-01 with a primary completion date of 2034-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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 & Investigator
Yan Bi, M.D., Ph.D.
STUDY DIRECTOR
Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
Frequently Asked Questions
Who can join the NCT06650969 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, studying Type 2 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06650969 currently recruiting?
Yes, NCT06650969 is actively recruiting participants. Contact the research team at biyan@nju.edu.cn for enrollment information.
Where is the NCT06650969 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT06650969 clinical trial?
NCT06650969 is sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School. The principal investigator is Yan Bi, M.D., Ph.D. at Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University. The trial plans to enroll 10,000 participants.
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