Actively Recruiting
Construction of Papez Loop Neural Network Feature Recognition Model and Prediction Model of Cognitive Impairment Progression Related to Insulin Resistance in Type 2 Diabetes Mellitus
Led by Nanjing First Hospital, Nanjing Medical University · Updated on 2025-04-04
400
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to study the changes in the neural network activity and connectivity of Papez's circuit in people with type 2 diabetes mellitus (T2DM). The study seeks to create a prediction model for the occurrence, development, and severity of cognitive impairment related to insulin resistance in T2DM. By using machine learning and multimodal MRI, the study will explore how key brain regions interact and affect cognitive function over time. Participants include 200 T2DM patients diagnosed according to the American Diabetes Association standards and 200 healthy controls with normal glucose tolerance and cognition. There is no intervention given during the study. All participants will undergo biochemical tests such as fasting blood glucose, C-peptide, HbA1c, blood lipids, and postprandial glucose and C-peptide. Additionally, multimodal MRI scans and cognitive assessments will be conducted at the start and during follow-up visits every 36 months, over a total study duration of 6 years. During the study, participants will have brain scans including structural, functional, diffusion tensor, and arterial spin labeling MRI, alongside neuropsychological tests and blood sample collection for neuropathology biomarkers. These assessments will be repeated at baseline and at 36 and 72 months. The study will track changes in brain imaging, cognitive performance, and biomarker levels to better understand and predict cognitive decline in T2DM. Data will be analyzed using machine learning approaches to develop predictive tools for clinical use.
CONDITIONS
Brief Title
Characteristics of Papez Loop Neural Network in T2DM （Type 2 Diabetes Mellitus）
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of type 2 diabetes mellitus according to WHO 1999 criteria with disease duration of 3-20 years, or healthy controls with fasting blood glucose < 6.1 mmol/l and HbA1c < 5.7%
- Right-handed individuals aged 45-70 years
- At least 6 years of education
- No contraindications to MRI scanning such as electronic or metal implants
- Visual and hearing abilities sufficient to complete cognitive and neurological evaluations
- No history of substance abuse or dependence and not using sedatives, antidepressants, or cognitive-enhancing drugs long-term during evaluation period
You will not qualify if you...
- Acute metabolic complications or history of severe hypoglycemia
- Severe diseases of heart, liver, lung, kidney, or blood system
- Thyroid disorders like hyperthyroidism or hypothyroidism
- History of stroke, Alzheimer's disease, epilepsy, Parkinson's disease, or other neurological disorders
- History of mental illnesses such as depression, mania, or alcohol dependence
- History of loss of consciousness due to neurological diseases or brain injury
- Records of recent trauma, infection, or surgery within one month before laboratory tests
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Within 1 week after screening visit
Participants undergo clinical information collection, biochemical measurements, multimodal MRI scans, and cognitive assessments to establish baseline data.
1 baseline visit (in-person)
Duration - 6 years with follow-ups every 36 months
Participants return every 36 months for repeat assessments including MRI scans, cognitive tests, and blood biomarker measurements to monitor changes over time.
Follow-up visits every 36 months (in-person), totaling 2 follow-up visits
Trial Site Locations
Total: 1 location
1
Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University
Nanjing, Jiangsu, China, 210000
Actively Recruiting
Research Team
W
Wenqing Xia, PHD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here