Investigating brain network changes in Type 2 Diabetes

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

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
• Enrollment: 400 (estimated)
• Ages: 45 Years to 70 Years
• Sex: All
• Sponsor: Nanjing First Hospital, Nanjing Medical University (other)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06912321 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: While studies have explored cognitive impairment in diabetes, this specific approach using the Papez circuit and machine learning is relatively novel.

Eligibility 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 this trial is running

Nanjing, Jiangsu

• Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University — Nanjing, Jiangsu, China (RECRUITING)

Study contacts

• Study coordinator: Wenqing Xia, PHD

Conditions: Type 2 Diabetes, Insulin Resistance, Cognitive Impairment, Papez circuit, Multimodal magnetic resonance imaging, Machine learning