RecruitingNCT06650969

China Diabetes Cognitive Dysfunction Early Diagnosis and Intervention Study (China-DECODE Study)


Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Enrollment

10,000 participants

Start Date

Oct 1, 2016

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether people with type 2 diabetes are at increased risk of developing thinking and memory problems (cognitive dysfunction) earlier than the general population. Researchers will do brain tests, imaging, and blood work to detect early signs and test whether diabetes management can reduce this risk. **You may be eligible if...** - You are 45 or older - You have been diagnosed with type 2 diabetes - You are willing and able to complete detailed memory and thinking tests - You have at least 6 years of education - You are right-handed **You may NOT be eligible if...** - You have already been diagnosed with dementia - You have had a recent serious diabetes episode (such as diabetic ketoacidosis or severe low blood sugar coma within the past 3 months) - You have a neurological or psychiatric condition - You have a history of cancer or severe heart/kidney problems - You are left-handed Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERNaturalistic observation

Naturalistic observation


Locations(1)

Department of Endocrinology, Endocrine and Metabolic Disease Medical Center, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University

Nanjing, Jiangsu, China

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NCT06650969


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