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

Last updated: October 23, 2022
Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Overall Status: Active - Recruiting

Phase

N/A

Condition

Memory Problems

Learning Disorders

Diabetes And Hypertension

Treatment

N/A

Clinical Study ID

NCT05545657
2022-LCYJ-MS-03
  • Ages 40-75
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Control participants would be excluded if they had a fasting blood glucose level >7.0mmol/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, includingpsychotic developmental disorders, mania, depression, and schizophrenia
  • Central neural system diseases, including traumatic brain injury, intracranialhemorrhage, and acute cerebral infarction
  • Acute complications of diabetes, including diabetic ketoacidosis, hyperglycemichyperosmolar 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

Study Design

Total Participants: 500
Study Start date:
October 18, 2022
Estimated Completion Date:
August 31, 2025

Study 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.

Connect with a study center

  • Department of Radiology, the Affiliated Drum Tower Hospital of Nanjing University

    Nanjing, Jiangsu 210008
    China

    Active - Recruiting

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