Clinical trial NCT05545657: Relationship and Central Mechanism Between Diabetes and Cognitive Impairment Based on Simultaneous EEG-fMRI Approach and Peripheral Neuropathology Biomarkers Assay
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type 2 Diabetes
Alzheimer Disease
Cognitive Impairment
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2022-09-19
Enrollment: 500
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: T2DM patients will be recruited from the outpatient and inpatient units of the endocrinology department of the investigator's hospital. Healthy control will be recruited in the community

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Aged 40-75 years
* Right handedness
* Possessed over 6-year education
* Provision of informed consent prior to any study specific procedures

Exclusion Criteria:

* 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

Primary outcomes:
measure: Baseline cognitive performance
timeFrame: Day 1 of entry study
measure: Baseline peripheral blood neuropathology biomarkers level
timeFrame: 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.
measure: Baseline simultaneous EEG-fMRI
timeFrame: Within 1 week after cognitive assessments
measure: Baseline brain structural MRI scan
timeFrame: Within 1 week after cognitive assessments
measure: Baseline brain functional MRI scan
timeFrame: Within 1 week after cognitive assessments
Secondary outcomes:
measure: Longitudinal changes of cognitive performance
timeFrame: From baseline to each follow-up time points (6 months, 12 months, 18 months, 24 months, 30months, 36 months).
measure: Longitudinal changes of peripheral blood neuropathology biomarkers level
timeFrame: From baseline to final follow-up time points (36 months).
measure: Longitudinal changes of simultaneous EEG-fMRI
timeFrame: From baseline to each follow-up time points (6 months, 12 months, 18 months, 24 months, 30months, 36 months).
measure: Longitudinal changes of brain structural MRI scan
timeFrame: From baseline to each follow-up time points (6 months, 12 months, 18 months, 24 months, 30months, 36 months).
measure: Longitudinal changes of brain functional MRI scan
timeFrame: From baseline to each follow-up time points (6 months, 12 months, 18 months, 24 months, 30months, 36 months).
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Department of Radiology, the Affiliated Drum Tower Hospital of Nanjing University
state: Jiangsu
Study officials:
References: