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

NCT06912321 | Recruiting

• 1 other identifier: KY20240419-04-KS-01
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes; Insulin Resistance; Cognitive Impairment

Keywords

Type 2 Diabetes; Insulin Resistance; Papez circuit; Multimodal magnetic resonance imaging; Machine learning

Outcome Measures

Primary Outcomes (18)

• Baseline brain structural MRI scan

  To calculate the volumes of whole brain and target brain regions

  Within 1 week after neuropsychological tests

• Baseline brain functional MRI scan

  To evaluate Papez loop cross-scale network variation

  Within 1 week after neuropsychological tests

• Baseline brain diffusion tensor MRI scan

  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

  Within 1 week after neuropsychological tests

• Baseline brain arterial spin labeling MRI scan

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

  Within 1 week after neuropsychological tests

• Baseline neuropsychological performance

  Montreal Cognitive Assessment，MoCA：It includes 11 examination items in 8 cognitive domains with a total score of 30 points

  Day 1 of entry study

• Baseline neuropsychological performance

  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

  Day 1 of entry study

• Baseline neuropsychological performance

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

  Day 1 of entry study

• Baseline neuropsychological performance

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

  Day 1 of entry study

• Baseline neuropsychological performance

  Trail making testTMT：includes two parts, A and B

  Day 1 of entry study

• Baseline neuropsychological performance

  Auditory Verbal Learning Test， VALT

  Day 1 of entry study

• Baseline neuropsychological performance

  Digit span test,DST

  Day 1 of entry study

• Baseline neuropsychological performance

  Digit Symbol Substitution Test, DSST

  Day 1 of entry study

• Baseline peripheral blood neuropathology biomarkers level

  Fasting blood glucose（mmol/L）

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

• Baseline peripheral blood neuropathology biomarkers level

  C-peptide（nmol/l）

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

• Baseline peripheral blood neuropathology biomarkers level

  HbA1c（mmol/mol）

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

• Baseline peripheral blood neuropathology biomarkers level

  blood lipid（mmol/L）

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

• Baseline peripheral blood neuropathology biomarkers level

  postprandial blood glucose（mmol/L）

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

• Baseline peripheral blood neuropathology biomarkers level

  postprandial C-peptide（nmol/l）

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

Secondary Outcomes (19)

• Longitudinal changes of brain structural MRI scan

  36 months, 72 months

• Longitudinal changes of brain functional MRI scan

  36 months, 72 months

• Longitudinal changes of brain diffusion tensor MRI scan

  36 months, 72 months

• Longitudinal changes of brain arterial spin labeling MRI scan

  36 months, 72 months

• Longitudinal changes of neuropsychological performance

  36 months, 72 months

Study Arms (2)

Type 2 Diabetes

These patients must have a definite diagnosis of type 2 diabetes mellitus (T2DM) according to the American Diabetes Association (ADA) standards

Other: No Intervention: Observational Cohort

Healthy control

These participants have normal glucose tolerance and normal cognition

Other: No Intervention: Observational Cohort

Interventions

No Intervention: Observational Cohort OTHER

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

Healthy control; Type 2 Diabetes

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

T2DM patients will be recruited from the outpatient and inpatient units of the endocrinology department of the investigator's hospital. Healthy control will be recruited in the community

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University

Nanjing, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Wenqing Xia, PHD

  Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China

  STUDY CHAIR

Central Study Contacts

Wenqing Xia, PHD

CONTACT

+8617749597285; wen_qing_xia@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: April 4, 2025
• Study Start: May 1, 2024
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: April 4, 2025

Record last verified: 2025-02

Locations

CN (1)