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NCT Number: NCT06912321

Characteristics of Papez Loop Neural Network in T2DM （Type 2 Diabetes Mellitus）

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.

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Key information

Conditions

Type 2 Diabetes Cognition Disorders Cognitive Dysfunction Cognitive Impairment Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Mental Disorders Metabolic Diseases Neurocognitive Disorders Nutritional and Metabolic Diseases

Age range

45 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University

Nanjing, Jiangsu, 210000, China

Location status: Recruiting

Location contact

Wenqing Xia, PHD

CONTACT

[email protected]

+8617749597285

About this study

T2DM patients may have multidimensional cognitive impairment, which is related to the damage of key brain regions in Papez's circuit. The purpose of this study is to establish a prediction model for the occurrence, development, and severity of cognitive impairment by using machine learning of Papez circuit neural network in T2DM patients. This will allow for early intelligent assessment with high accuracy and efficiency, and assist in clinical personalized treatment and early intervention. The research center has 1 principal investigator, 4 sub-investigators, and 1 nurse. Participants will include 200 patients with type 2 diabetes recruited from outpatient and inpatient departments. Additionally, 200 healthy controls will be recruited from the community. Each subject will undergo clinical information collection, biochemical measurements including fasting blood glucose, C-peptide, HbA1c, blood lipid, postprandial blood glucose, and postprandial C-peptide, multimodal MRI scans, and cognitive assessments at baseline and each follow-up visit. The study duration is 6 years, with a follow-up every 36 months. At the end of the study, all assessments will be performed again for all recruited subjects.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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%;
  • right-handed, aged 45-70 years, with ≥8 years of education;
  • no contraindications to MRI scanning such as electronic and metal device implantation;
  • The visual acuity or corrected visual acuity and binaural hearing can meet the needs of the evaluation, and can cooperate to complete the examination.
  • 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

  • patients with acute metabolic complications or a history of severe hypoglycemia;
  • 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;
  • one month before the laboratory examination, with a record and surgical trauma infection;

Treatment and study plan

No Intervention: Observational Cohort

Other

No intervention：all participants did not receive any intervention measures throughout the study

Primary outcomes

  1. Baseline brain structural MRI scan

    Time frame: Within 1 week after neuropsychological tests

    To calculate the volumes of whole brain and target brain regions

  2. Baseline brain functional MRI scan

    Time frame: Within 1 week after neuropsychological tests

    To evaluate Papez loop cross-scale network variation

  3. Baseline brain diffusion tensor MRI scan

    Time frame: 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

  4. Baseline brain arterial spin labeling MRI scan

    Time frame: Within 1 week after neuropsychological tests

    To calculate the blood perfusion in the whole brain and Papez circuit

  5. Baseline neuropsychological performance

    Time frame: 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

  6. Baseline neuropsychological performance

    Time frame: 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

  7. Baseline neuropsychological performance

    Time frame: Day 1 of entry study

    Complex Figure Test, CFT: The total score is 36 points, including position score and shape score

  8. Baseline neuropsychological performance

    Time frame: Day 1 of entry study

    Verbalfluencytest, VFT: includes semantic fluency test, speech fluency test, and action fluency test

  9. Baseline neuropsychological performance

    Time frame: Day 1 of entry study

    Trail making testTMT：includes two parts, A and B

  10. Baseline neuropsychological performance

    Time frame: Day 1 of entry study

    Auditory Verbal Learning Test， VALT

  11. Baseline neuropsychological performance

    Time frame: Day 1 of entry study

    Digit span test,DST

  12. Baseline neuropsychological performance

    Time frame: Day 1 of entry study

    Digit Symbol Substitution Test, DSST

  13. Baseline peripheral blood neuropathology biomarkers level

    Time frame: Blood samples will be collected on day 1 of the entry study

    Fasting blood glucose（mmol/L）

  14. Baseline peripheral blood neuropathology biomarkers level

    Time frame: Blood samples will be collected on day 1 of the entry study

    C-peptide（nmol/l）

  15. Baseline peripheral blood neuropathology biomarkers level

    Time frame: Blood samples will be collected on day 1 of the entry study

    HbA1c（mmol/mol）

  16. Baseline peripheral blood neuropathology biomarkers level

    Time frame: Blood samples will be collected on day 1 of the entry study

    blood lipid（mmol/L）

  17. Baseline peripheral blood neuropathology biomarkers level

    Time frame: Blood samples will be collected on day 1 of the entry study

    postprandial blood glucose（mmol/L）

  18. Baseline peripheral blood neuropathology biomarkers level

    Time frame: Blood samples will be collected on day 1 of the entry study

    postprandial C-peptide（nmol/l）

Secondary outcomes

  1. Longitudinal changes of brain structural MRI scan

    Time frame: 36 months, 72 months

    Compare the changes of the volumes of whole brain and target brain regions from baseline to each follow-up time points

  2. Longitudinal changes of brain functional MRI scan

    Time frame: 36 months, 72 months

    Compare the changes of the Papez circuit cross-scale network variation from baseline to each follow-up time points

  3. Longitudinal changes of brain diffusion tensor MRI scan

    Time frame: 36 months, 72 months

    Compare the changes of the Papez circuit structural network from baseline to each follow-up time points

  4. Longitudinal changes of brain arterial spin labeling MRI scan

    Time frame: 36 months, 72 months

    Compare the changes of blood perfusion in the whole brain and Papez circuit from baseline to each follow-up time points

  5. Longitudinal changes of neuropsychological performance

    Time frame: 36 months, 72 months

    Compare the Montreal Cognitive Assessment(MoCA) change from the baseline to each follow-up time points

  6. Longitudinal changes of neuropsychological performance

    Time frame: 36 months, 72 months

    Compare the Mini-mental State Examination (MMSE) change from the baseline to each follow-up time points

  7. Longitudinal changes of neuropsychological performance

    Time frame: 36 months, 72 months

    Compare the Complex Figure Test (CFT) change from the baseline to each follow-up time points

  8. Longitudinal changes of neuropsychological performance

    Time frame: 36 months, 72 months

    Compare the Verbalfluencytest (VFT) change from the baseline to each follow-up time points

  9. Longitudinal changes of neuropsychological performance

    Time frame: 36 months, 72 months

    Compare the Trail making test (TMT) change from the baseline to each follow-up time points; includes two parts, A and B

  10. Longitudinal changes of neuropsychological performance

    Time frame: 36 months, 72 months

    Compare the Auditory Verbal Learning Test (VALT) change from the baseline to each follow-up time points

  11. Longitudinal changes of neuropsychological performance

    Time frame: 36 months, 72 months

    Compare the Digit span test (DST) change from the baseline to each follow-up time points

  12. Longitudinal changes of neuropsychological performance

    Time frame: 36 months, 72 months

    Compare the Digit Symbol Substitution Test (DSST) change from the baseline to each follow-up time points

  13. Longitudinal changes of peripheral blood neuropathology biomarkers leve

    Time frame: 36 months, 72 months

    Compare the fasting blood glucose（mmol/L）changes from baseline to each follow-up time points

  14. Longitudinal changes of peripheral blood neuropathology biomarkers leve

    Time frame: 36 months, 72 months

    Compare the C-peptide（nmol/l）changes from baseline to each follow-up time points

  15. Longitudinal changes of peripheral blood neuropathology biomarkers leve

    Time frame: 36 months, 72 months

    Compare the HbA1c（mmol/mol）changes from baseline to each follow-up time points

  16. Longitudinal changes of peripheral blood neuropathology biomarkers leve

    Time frame: 36 months, 72 months

    Compare the blood lipid（mmol/L）changes from baseline to each follow-up time points

  17. Longitudinal changes of peripheral blood neuropathology biomarkers leve

    Time frame: 36 months, 72 months

    Compare the postprandial blood glucose（mmol/L）changes from baseline to each follow-up time points

  18. Longitudinal changes of peripheral blood neuropathology biomarkers leve

    Time frame: 36 months, 72 months

    Compare the postprandial C-peptide（nmol/l）changes from baseline to each follow-up time points

  19. Machine learning of multimodal MRI data

    Time frame: 72 months

    Multimodal MRI data for machine learning, can be in different levels of calculation and analysis and research on the characteristics of neural network, found a pattern classification and predict unknown data effectively, find out the Papez loop associated with insulin resistance characteristics of neural network

Study contacts

Contact information is provided by the study sponsor or research team.

Wenqing Xia, PHD

CONTACT

[email protected]

+8617749597285

Sponsors and collaborators

Lead sponsor

Nanjing First Hospital, Nanjing Medical University

Other

Registry information

Official study 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

Acronym: T2DM

Important dates

Study start
2024
Primary completion
2030
Study completion
2030
First posted
Apr 4, 2025
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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