Studies memory and thinking changes in people with type 2 diabetes
Observes thinking and memory problems in adults over 45 with type 2 diabetes.
Plain-language title generated from the registry record
Registry title: China Diabetes Cognitive Dysfunction Early Diagnosis and Intervention Study (China-DECODE Study)
Key facts
- Where
- Nanjing, ChinaSee the site
Where in China
- Department of Endocrinology, Endocrine and Metabolic Disease Medical Center,Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing UniversityNanjing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Trial code
- NCT06650969
- Record updated
- 21 October 2024
- Original description
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.Read full original descriptionShow less
China Diabetes Cognitive Dysfunction Early Diagnosis and Intervention Study (China-DECODE Study)
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.
Inclusion: 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: Acute metabolic complications such as diabetic ketoacidosis, hyperglycaemic hyperosmolar state and hypoglycaemic coma within the previous 3 months; Dementia; History or presence of neurological or psychiatric disorders; History of malignancy, or severe kidney or liver dysfunction; Fewer than 6 years of education; Left-handedness; Presence of hypothyroidism.