Investigating brain network changes in Type 2 Diabetes
Official title: 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
Run by Nanjing First Hospital, Nanjing Medical University · NCT06912321 · Data updated 2026-11-12
This study is trying to see how Type 2 Diabetes affects brain activity and connections over time to help find ways to spot and treat cognitive problems early.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 45 Years to 70 Years |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | Nanjing First Hospital, Nanjing Medical University Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Status | Recruiting |
| Started | May 1, 2024 |
| Main results expected | May 1, 2030 |
| Study ends | December 31, 2030 |
| Registry record updated | April 4, 2025 |
| Trial ID | NCT06912321 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include right-handed individuals aged 45-70 with a diagnosis of Type 2 Diabetes for 3-20 years and no contraindications to MRI.
✕Probably not a fit
Patients with acute metabolic complications, severe comorbidities, or neurological disorders such as Alzheimer's or Parkinson's disease may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to explore the changes in the Papez circuit neural network activity and connectivity in patients with Type 2 Diabetes Mellitus (T2DM) using multimodal MRI and machine learning techniques. It will involve 200 T2DM patients and 200 healthy controls, who will undergo clinical assessments, biochemical measurements, and cognitive evaluations over a 6-year period with follow-ups every 36 months. The goal is to develop a predictive model for cognitive impairment associated with T2DM, facilitating early assessment and personalized treatment strategies.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection and management of cognitive impairment in patients with Type 2 Diabetes.
How similar studies have gone: While studies have explored cognitive impairment in diabetes, this specific approach using the Papez circuit and machine learning is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. T2DM patients met the diagnostic criteria for diabetes (WHO, 1999) with a duration of 3-20 years; The control group met the criteria of fasting blood glucose \< 6.1mmol/l and glycosylated hemoglobin \< 5.7%; 2. right-handed, aged 45-70 years, with ≥8 years of education; 3. no contraindications to MRI scanning such as electronic and metal device implantation; 4. The visual acuity or corrected visual acuity and binaural hearing can meet the needs of the evaluation, and can cooperate to complete the examination. 5. without a history of substance abuse or dependence, evaluation is not used during the period of calm sleeping pills and antidepressants, not long-term use of drugs to improve cognitive. Exclusion Criteria: 1. patients with acute metabolic complications or a history of severe hypoglycemia; 2. severe heart, liver, lung, kidney and hematopoietic system diseases; Hyperthyroidism or hypothyroidism; Stroke, alzheimer's disease, epilepsy, Parkinson's disease and other neurological history; A history of mental illness such as depression, mania, or alcohol dependence; History of loss of consciousness due to neurological diseases or traumatic brain injury; 3. one month before the laboratory examination, with a record and surgical trauma infection;
Where it's running
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Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University
Nanjing, Jiangsu, China Recruiting
Study contacts
- Study coordinator: Wenqing Xia, PHD
- Email: wen_qing_xia@126.com
- Phone: +8617749597285
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.