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

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05545657
• Other study ID #: 2022-LCYJ-MS-03
• Status: Recruiting
• Start date: October 18, 2022
• Est. completion date: August 31, 2025

Study information

• Verified date: August 2022
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: Bing Zhang, MD, PhD
• Phone: 86-15851803070
• Email: zhangbing_nanjing[@]vip.163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: August 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Cognitive Impairment
• Diabetes Mellitus
• Type 2 Diabetes

Intervention

Behavioral:
• Cognitive assessments
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).

Other:
• Simultaneous EEG-fMRI scan
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.
• Multimodal magnetic resonance imaging
3D T1-weighted imaging, Resting-state fMRI, Diffusion tensor imaging, Arterial spin labeling.
• Peripheral blood neuropathology biomarkers assay
Detecting the peripheral blood neuropathology biomarkers using single molecule array (Simoa) technique, including Aß40, Aß42, P-tau 181, P-tau 231, GFAP and NfL.

Locations

Country	Name	City	State
China	Department of Radiology, the Affiliated Drum Tower Hospital of Nanjing University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline cognitive performance	The Montreal Cognitive Assessment (MoCA) score, ranges from 0 to 30, and higher scores mean better cognition.	Day 1 of entry study
Primary	Baseline peripheral blood neuropathology biomarkers level	Aß40, Aß42, P-tau 181, P-tau 231, GFAP and NfL.	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.
Primary	Baseline simultaneous EEG-fMRI	Frequency domain and spectrum domain analyses	Within 1 week after cognitive assessments
Primary	Baseline brain structural MRI scan	Cortical morphology	Within 1 week after cognitive assessments
Primary	Baseline brain functional MRI scan	Large-scale network functional connectivity	Within 1 week after cognitive assessments
Secondary	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).	From baseline to each follow-up time points (6 months, 12 months, 18 months, 24 months, 30months, 36 months).
Secondary	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).	From baseline to final follow-up time points (36 months).
Secondary	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).	From baseline to each follow-up time points (6 months, 12 months, 18 months, 24 months, 30months, 36 months).
Secondary	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).	From baseline to each follow-up time points (6 months, 12 months, 18 months, 24 months, 30months, 36 months).
Secondary	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).	From baseline to each follow-up time points (6 months, 12 months, 18 months, 24 months, 30months, 36 months).