Clinical Trials in China / NCT06912321
Recruiting
Observational
Characteristics of Papez Loop Neural Network in T2DM （Type 2 Diabetes Mellitus）
NCT06912321 · tracked via the Priya Life Science China tracker
Condition(s) studied
Type 2 DiabetesInsulin ResistanceCognitive Impairment
Investigational drug(s) / intervention(s)
No Intervention: Observational Cohort
No Intervention: Observational Cohort: No intervention：all participants did not receive any intervention measures throughout the study
Study summary
This is a cross-sectional and longitudinal study to investigate the characteristic changes in Papez's circuit neural network activity and connectivity based on multimodal MRI, and through follow-up study of the interaction between the internal brain regions of Papez circuit and the function of the external neural network, a prediction model of the characteristic changes of Papez circuit neural network was constructed based on machine learning technology.
Eligibility
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;
Primary outcome measure(s)
- Baseline brain structural MRI scan — Within 1 week after neuropsychological tests
To calculate the volumes of whole brain and target brain regions - Baseline brain functional MRI scan — Within 1 week after neuropsychological tests
To evaluate Papez loop cross-scale network variation - Baseline brain diffusion tensor MRI scan — Within 1 week after neuropsychological tests
To trace and reconstruct the nerve fiber tracts between the Papez circuit related brain regions and between the circuit and the outer brain regions, and to construct a structural connection network according to the characteristics of white matter conduction pathways - Baseline brain arterial spin labeling MRI scan — Within 1 week after neuropsychological tests
To calculate the blood perfusion in the whole brain and Papez circuit - Baseline neuropsychological performance — Day 1 of entry study
Montreal Cognitive Assessment，MoCA：It includes 11 examination items in 8 cognitive domains with a total score of 30 points - Baseline neuropsychological performance — Day 1 of entry study
Mini-mental State Examination，MMSE：The highest score is 30 points, with scores between 27-30 indicating normal and scores below 27 indicating cognitive impairment - Baseline neuropsychological performance — Day 1 of entry study
Complex Figure Test, CFT: The total score is 36 points, including position score and shape score - Baseline neuropsychological performance — Day 1 of entry study
Verbalfluencytest, VFT: includes semantic fluency test, speech fluency test, and action fluency test - Baseline neuropsychological performance — Day 1 of entry study
Trail making testTMT：includes two parts, A and B - Baseline neuropsychological performance — Day 1 of entry study
Auditory Verbal Learning Test， VALT - Baseline neuropsychological performance — Day 1 of entry study
Digit span test,DST - Baseline neuropsychological performance — Day 1 of entry study
Digit Symbol Substitution Test, DSST - Baseline peripheral blood neuropathology biomarkers level — Blood samples will be collected on day 1 of the entry study
Fasting blood glucose（mmol/L） - Baseline peripheral blood neuropathology biomarkers level — Blood samples will be collected on day 1 of the entry study
C-peptide（nmol/l） - Baseline peripheral blood neuropathology biomarkers level — Blood samples will be collected on day 1 of the entry study
HbA1c（mmol/mol） - Baseline peripheral blood neuropathology biomarkers level — Blood samples will be collected on day 1 of the entry study
blood lipid（mmol/L） - Baseline peripheral blood neuropathology biomarkers level — Blood samples will be collected on day 1 of the entry study
postprandial blood glucose（mmol/L） - Baseline peripheral blood neuropathology biomarkers level — Blood samples will be collected on day 1 of the entry study
postprandial C-peptide（nmol/l）
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University | Nanjing | Jiangsu | Recruiting |
More Nanjing First Hospital, Nanjing Medical University trials in China
The Study of Postoperative Delirium and Glymphatic System Function in Cardiac Surgery
Active, not recruiting
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06912321 on ClinicalTrials.gov ↗ ← All trials in China