Relationship and Central Mechanism Between Diabetes and Cognitive Impairment Based on Simultaneous EEG-fMRI Approach and Peripheral Neuropathology Biomarkers Assay

Nanjing University

Status: Enrolling

Conditions: Alzheimer Disease; Cognitive Impairment; Type 2 Diabetes

Treatments: Behavioral: Cognitive assessments; Other: Multimodal magnetic resonance imaging; Other: Simultaneous EEG-fMRI scan; Other: Peripheral blood neuropathology biomarkers assay

Study type: Observational

Funder types: Other

Identifiers

NCT05545657

2022-LCYJ-MS-03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

500 participants in 2 patient groups

Type 2 Diabetes

Description:

These patients must have a definite diagnosis of type 2 diabetes mellitus (T2DM) according to the American Diabetes Association (ADA) standards. Some of these patients have symptoms of cognitive impairment, while others have normal cognition.

Treatment:

Behavioral: Cognitive assessments

Other: Peripheral blood neuropathology biomarkers assay

Other: Multimodal magnetic resonance imaging

Other: Simultaneous EEG-fMRI scan

Healthy Control

Description:

These participants have normal glucose tolerance and normal cognition.

Treatment:

Behavioral: Cognitive assessments

Other: Peripheral blood neuropathology biomarkers assay

Other: Multimodal magnetic resonance imaging

Other: Simultaneous EEG-fMRI scan