A Cross-sectional and Longitudinal Study to Investigate the Relationship and Central Mechanism Between Diabetes and Cognitive Impairment Based on Simultaneous EEG-fMRI Approach and Peripheral Neuropathology Biomarkers Assay
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Baseline brain functional MRI scan
研究概览
简要总结
This is a cross-sectional and longitudinal study to investigate the relationship and central mechanism between type 2 diabetes and cognitive impairment based on the simultaneous EEG-fMRI approach and peripheral neuropathology biomarkers assay.
详细描述
Little is known about the high risks of cognitive impairment and Alzheimer's Disease (AD) in people with type 2 diabetes. The goal of this study is to characterize brain imaging biomarkers of preclinical AD and related cognitive impairment in people with type 2 diabetes using the simultaneous EEG-fMRI approach and peripheral neuropathology biomarkers assay. We will recruit 400 patients with type 2 diabetes in the outpatient and inpatient departments. Each subject will undergo simultaneous EEG-fMRI scan, classical multimodal MRI scan, cognitive assessments and peripheral neuropathology biomarkers assay at the baseline. This study will qualify gray matter volume, cortical thickness, gray matter and white matter microstructure, cerebral blood flow, spectrum changes, as well as resting state and dynamic functional network connectivity from the imaging examination. Study duration was 3 years with a follow-up every 12 months. Cognitive assessments and imaging scan will be conducted in each follow-up visits. At the end of the study, all of the assessments will be performed again for all recruited subjects.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 40-75 years
- •Right handedness
- •Possessed over 6-year education
- •Provision of informed consent prior to any study specific procedures
排除标准
- •Control participants would be excluded if they had a fasting blood glucose level >7.0 mmol/L; glucose level> 7.8 mmol/L after oral glucose tolerance test (OGTT); HbA1c>5.7%
- •Control participants would be excluded if they had a Montreal Cognitive Assessment (MoCA, Beijing edition) score of < 26
- •History of other dementia-related neurological or psychiatric disorders, including psychotic developmental disorders, mania, depression, and schizophrenia
- •Central neural system diseases, including traumatic brain injury, intracranial hemorrhage, and acute cerebral infarction
- •Acute complications of diabetes, including diabetic ketoacidosis, hyperglycemic hyperosmolar state, and hypoglycemic coma
- •Complicated with severe impairment of liver, kidney or heart function
- •Metal implants, unable to complete the MR scanning
- •Pregnant or lactating women
结局指标
主要结局
Baseline brain functional MRI scan
时间窗: Within 1 week after cognitive assessments
Large-scale network functional connectivity
Baseline peripheral blood neuropathology biomarkers level
时间窗: Blood samples will be collected on day 1 of the entry study and preserved at -81 °C in the Biobank of Drum Tower Hospital until examination.
Aβ40, Aβ42, P-tau 181, P-tau 231, GFAP and NfL.
Baseline simultaneous EEG-fMRI
时间窗: Within 1 week after cognitive assessments
Frequency domain and spectrum domain analyses
Baseline cognitive performance
时间窗: Day 1 of entry study
The Montreal Cognitive Assessment (MoCA) score, ranges from 0 to 30, and higher scores mean better cognition.
Baseline brain structural MRI scan
时间窗: Within 1 week after cognitive assessments
Cortical morphology
次要结局
- Longitudinal changes of peripheral blood neuropathology biomarkers level(From baseline to final follow-up time points (36 months).)
- Longitudinal changes of brain functional MRI scan(From baseline to each follow-up time points (6 months, 12 months, 18 months, 24 months, 30months, 36 months).)
- Longitudinal changes of cognitive performance(From baseline to each follow-up time points (6 months, 12 months, 18 months, 24 months, 30months, 36 months).)
- Longitudinal changes of simultaneous EEG-fMRI(From baseline to each follow-up time points (6 months, 12 months, 18 months, 24 months, 30months, 36 months).)
- Longitudinal changes of brain structural MRI scan(From baseline to each follow-up time points (6 months, 12 months, 18 months, 24 months, 30months, 36 months).)