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.
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.
Study Type
OBSERVATIONAL
Enrollment
500
Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), Rey Auditory Verbal Learning Test (RAVLT), Boston Naming Test (BNT), Digit Span Test (DST), Trail Making Test (TMT).
EEG recordings were conducted with a 64-channel MR-compatible EEG system (Electrical Geodesics Inc., Eugene, OR, USA) and an MR-compatible EEG cap (HydroCel Geodesic Sensor Nets), using ring-type sintered silver chloride electrodes with iron-free copper leads.
3D T1-weighted imaging, Resting-state fMRI, Diffusion tensor imaging, Arterial spin labeling.
Detecting the peripheral blood neuropathology biomarkers using single molecule array (Simoa) technique, including Aβ40, Aβ42, P-tau 181, P-tau 231, GFAP and NfL.
Department of Radiology, the Affiliated Drum Tower Hospital of Nanjing University
Nanjing, Jiangsu, China
RECRUITINGBaseline cognitive performance
The Montreal Cognitive Assessment (MoCA) score, ranges from 0 to 30, and higher scores mean better cognition.
Time frame: Day 1 of entry study
Baseline peripheral blood neuropathology biomarkers level
Aβ40, Aβ42, P-tau 181, P-tau 231, GFAP and NfL.
Time frame: 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.
Baseline simultaneous EEG-fMRI
Frequency domain and spectrum domain analyses
Time frame: Within 1 week after cognitive assessments
Baseline brain structural MRI scan
Cortical morphology
Time frame: Within 1 week after cognitive assessments
Baseline brain functional MRI scan
Large-scale network functional connectivity
Time frame: Within 1 week after cognitive assessments
Longitudinal changes of cognitive performance
Compare the change of MoCA score from baseline to each follow-up time points (6 months, 12 months, 18 months, 24 months, 30months, 36 months).
Time frame: From baseline to each follow-up time points (6 months, 12 months, 18 months, 24 months, 30months, 36 months).
Longitudinal changes of peripheral blood neuropathology biomarkers level
Compare the changes of peripheral blood neuropathology biomarkers level from baseline to final follow-up time points (36 months).
Time frame: From baseline to final follow-up time points (36 months).
Longitudinal changes of simultaneous EEG-fMRI
Compare the change of frequency domain and spectrum domain from baseline to each follow-up time points (6 months, 12 months, 18 months, 24 months, 30months, 36 months).
Time frame: 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
Compare the changes of cortical morphology from baseline to each follow-up time points (6 months, 12 months, 18 months, 24 months, 30months, 36 months).
Time frame: From baseline to each follow-up time points (6 months, 12 months, 18 months, 24 months, 30months, 36 months).
Longitudinal changes of brain functional MRI scan
Compare the changes of large-scale network functional connectivity from baseline to each follow-up time points (6 months, 12 months, 18 months, 24 months, 30months, 36 months).
Time frame: From baseline to each follow-up time points (6 months, 12 months, 18 months, 24 months, 30months, 36 months).
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