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临床试验/NCT06650969
NCT06650969招募中不适用

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

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School1 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2016年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
10,000
试验地点
1
主要终点
Prevalence, incidence of cognitive dysfunction in type 2 diabetes

研究概览

简要总结

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.

详细描述

The neuropsychological test battery are used to access the cognitive function of subjects in the study. The laboratory examinations, brain MRI and olfactory function measurements will be done in the screening period. The samples such as plasma, serum, urine and faeces et al. of the subjects will be collected in the study.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
45 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Prevalence, incidence of cognitive dysfunction in type 2 diabetes

时间窗: From 2016 to 2034

Prevalence, incidence of mild cognitive impairment in type 2 diabetes

Risk factors for cognitive dysfunction in type 2 diabetes, such as diabetes duration, poor glycemic control, hypertension, obesity, dyslipidemia, and active inflammation, et al.

时间窗: From 2016 to 2034

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.

Biomarkers of cognitive dysfunction in type 2 diabetes

时间窗: From 2016 to 2034

Diagnostic biomarkers, predictive biomarkers, and prognostic biomarkers of cognitive dysfunction in type 2 diabetes

Glycemic control targets for cognitive dysfunction in type 2 diabetes

时间窗: From 2016 to 2034

Glycemic control targets (including glycated hemoglobin, glycemic fluctuations and hypoglycemic events) for slowing or reversing disease progression of cognitive dysfunction in type 2 diabetes.

次要结局

未报告次要终点

研究者

发起方
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yan Bi

Principal Investigator

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

研究点 (1)

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