Investigating the link between diabetes and cognitive impairment using brain imaging and biomarkers
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
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · NCT05545657
This study is trying to see how type 2 diabetes affects thinking and memory by looking at brain scans and other tests in 400 patients aged 40-75 over three years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 40 Years to 75 Years |
| Sex | All |
| Sponsor | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School (other) |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT05545657 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the relationship between type 2 diabetes and cognitive impairment, particularly Alzheimer's Disease, through a combination of simultaneous EEG-fMRI scans and peripheral neuropathology biomarkers. It will recruit 400 patients aged 40-75 with type 2 diabetes, who will undergo various assessments including brain imaging and cognitive evaluations at baseline and during follow-ups over three years. The study seeks to identify brain imaging biomarkers associated with cognitive decline in this population, providing insights into the underlying mechanisms of the relationship between diabetes and cognitive impairment.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 40-75 with a diagnosis of type 2 diabetes and a minimum of 6 years of education.
Not a fit: Patients with significant cognitive impairment, other neurological disorders, or severe complications from diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and early detection of cognitive impairment in patients with type 2 diabetes, potentially guiding preventive strategies.
How similar studies have performed: While the specific combination of EEG-fMRI and biomarkers in this context may be novel, previous studies have indicated a relationship between diabetes and cognitive decline, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Nanjing, Jiangsu
- Department of Radiology, the Affiliated Drum Tower Hospital of Nanjing University — Nanjing, Jiangsu, China (RECRUITING)
Study contacts
- Study coordinator: Bing Zhang, MD, PhD
- Email: zhangbing_nanjing@vip.163.com
- Phone: 86-15851803070
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Type 2 Diabetes, Alzheimer Disease, Cognitive Impairment