Type 2 DiabetesT2DMNCT06912321
Characteristics of Papez Loop Neural Network in T2DM （Type 2 Diabetes Mellitus）
An observational study of Type 2 Diabetes and Insulin Resistance, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Insulin Resistance, Cognitive Impairment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University
Nanjing, Jiangsu, 210000
Wenqing Xia, PHD, +8617749597285, wen_qing_xia@126.com
About this study
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
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.
Read the detailed description
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.
- Conditions
- Type 2 Diabetes, Insulin Resistance, Cognitive Impairment
- Being tested
- No Intervention: Observational Cohort
- Keywords
- Type 2 Diabetes, Insulin Resistance, Papez circuit, Multimodal magnetic resonance imaging, Machine learning
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
No intervention：all participants did not receive any intervention measures throughout the study
| Study group | Role | What they receive |
|---|---|---|
| Type 2 Diabetes | These patients must have a definite diagnosis of type 2 diabetes mellitus (T2DM) according to the American Diabetes Association (ADA) standards Receives: Other: No Intervention: Observational Cohort | |
| Healthy control | These participants have normal glucose tolerance and normal cognition Receives: Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline brain structural MRI scan
To calculate the volumes of whole brain and target brain regions
Measured: Within 1 week after neuropsychological tests
Baseline brain functional MRI scan
To evaluate Papez loop cross-scale network variation
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Day 1 of entry study
Baseline neuropsychological performance
Complex Figure Test, CFT: The total score is 36 points, including position score and shape score
Measured: Day 1 of entry study
Baseline neuropsychological performance
Verbalfluencytest, VFT: includes semantic fluency test, speech fluency test, and action fluency test
Measured: Day 1 of entry study
Baseline neuropsychological performance
Trail making testTMT：includes two parts, A and B
Measured: Day 1 of entry study
Baseline neuropsychological performance
Auditory Verbal Learning Test， VALT
Measured: Day 1 of entry study
Baseline neuropsychological performance
Digit span test,DST
Measured: Day 1 of entry study
Baseline neuropsychological performance
Digit Symbol Substitution Test, DSST
Measured: Day 1 of entry study
Baseline peripheral blood neuropathology biomarkers level
Fasting blood glucose（mmol/L）
Measured: Blood samples will be collected on day 1 of the entry study
Baseline peripheral blood neuropathology biomarkers level
C-peptide（nmol/l）
Measured: Blood samples will be collected on day 1 of the entry study
Baseline peripheral blood neuropathology biomarkers level
HbA1c（mmol/mol）
Measured: Blood samples will be collected on day 1 of the entry study
Baseline peripheral blood neuropathology biomarkers level
blood lipid（mmol/L）
Measured: Blood samples will be collected on day 1 of the entry study
Baseline peripheral blood neuropathology biomarkers level
postprandial blood glucose（mmol/L）
Measured: Blood samples will be collected on day 1 of the entry study
Baseline peripheral blood neuropathology biomarkers level
postprandial C-peptide（nmol/l）
Measured: Blood samples will be collected on day 1 of the entry study
Secondary outcomes (19)
Longitudinal changes of brain structural MRI scan
Compare the changes of the volumes of whole brain and target brain regions from baseline to each follow-up time points
Measured: 36 months, 72 months
Longitudinal changes of brain functional MRI scan
Compare the changes of the Papez circuit cross-scale network variation from baseline to each follow-up time points
Measured: 36 months, 72 months
Longitudinal changes of brain diffusion tensor MRI scan
Compare the changes of the Papez circuit structural network from baseline to each follow-up time points
Measured: 36 months, 72 months
Longitudinal changes of brain arterial spin labeling MRI scan
Compare the changes of blood perfusion in the whole brain and Papez circuit from baseline to each follow-up time points
Measured: 36 months, 72 months
Longitudinal changes of neuropsychological performance
Compare the Montreal Cognitive Assessment(MoCA) change from the baseline to each follow-up time points
Measured: 36 months, 72 months
Longitudinal changes of neuropsychological performance
Compare the Mini-mental State Examination (MMSE) change from the baseline to each follow-up time points
Measured: 36 months, 72 months
Longitudinal changes of neuropsychological performance
Compare the Complex Figure Test (CFT) change from the baseline to each follow-up time points
Measured: 36 months, 72 months
Longitudinal changes of neuropsychological performance
Compare the Verbalfluencytest (VFT) change from the baseline to each follow-up time points
Measured: 36 months, 72 months
Longitudinal changes of neuropsychological performance
Compare the Trail making test (TMT) change from the baseline to each follow-up time points; includes two parts, A and B
Measured: 36 months, 72 months
Longitudinal changes of neuropsychological performance
Compare the Auditory Verbal Learning Test (VALT) change from the baseline to each follow-up time points
Measured: 36 months, 72 months
Longitudinal changes of neuropsychological performance
Compare the Digit span test (DST) change from the baseline to each follow-up time points
Measured: 36 months, 72 months
Longitudinal changes of neuropsychological performance
Compare the Digit Symbol Substitution Test (DSST) change from the baseline to each follow-up time points
Measured: 36 months, 72 months
Longitudinal changes of peripheral blood neuropathology biomarkers leve
Compare the fasting blood glucose（mmol/L）changes from baseline to each follow-up time points
Measured: 36 months, 72 months
Longitudinal changes of peripheral blood neuropathology biomarkers leve
Compare the C-peptide（nmol/l）changes from baseline to each follow-up time points
Measured: 36 months, 72 months
Longitudinal changes of peripheral blood neuropathology biomarkers leve
Compare the HbA1c（mmol/mol）changes from baseline to each follow-up time points
Measured: 36 months, 72 months
Longitudinal changes of peripheral blood neuropathology biomarkers leve
Compare the blood lipid（mmol/L）changes from baseline to each follow-up time points
Measured: 36 months, 72 months
Longitudinal changes of peripheral blood neuropathology biomarkers leve
Compare the postprandial blood glucose（mmol/L）changes from baseline to each follow-up time points
Measured: 36 months, 72 months
Longitudinal changes of peripheral blood neuropathology biomarkers leve
Compare the postprandial C-peptide（nmol/l）changes from baseline to each follow-up time points
Measured: 36 months, 72 months
Machine learning of multimodal MRI data
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
Measured: 72 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start1 May 2024
- Primary completion1 May 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wenqing Xia, PHD, Study chair, Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06912321
- Sponsor's protocol ID
- KY20240419-04-KS-01
- Acronym
- T2DM
- Status last verified
- Feb 2025
- First submitted
- 23 May 2024
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06912321
- Acronym / sponsor ID
- T2DM / KY20240419-04-KS-01
- Conditions
- Type 2 Diabetes, Insulin Resistance, Cognitive Impairment
- Keywords
- Type 2 Diabetes, Insulin Resistance, Papez circuit, Multimodal magnetic resonance imaging, Machine learning
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 May 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 4 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Type 2 Diabetes | – | Other: No Intervention: Observational CohortThese patients must have a definite diagnosis of type 2 diabetes mellitus (T2DM) according to the American Diabetes Association (ADA) standards |
| Healthy control | – | Other: No Intervention: Observational CohortThese participants have normal glucose tolerance and normal cognition |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention: Observational CohortNo intervention：all participants did not receive any intervention measures throughout the study | Other | Healthy control, Type 2 Diabetes |
Primary outcome
Baseline brain structural MRI scan
Time frame: Within 1 week after neuropsychological tests
To calculate the volumes of whole brain and target brain regions
Baseline brain functional MRI scan
Time frame: Within 1 week after neuropsychological tests
To evaluate Papez loop cross-scale network variation
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
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
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
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
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
Baseline neuropsychological performance
Time frame: Day 1 of entry study
Verbalfluencytest, VFT: includes semantic fluency test, speech fluency test, and action fluency test
Baseline neuropsychological performance
Time frame: Day 1 of entry study
Trail making testTMT：includes two parts, A and B
Baseline neuropsychological performance
Time frame: Day 1 of entry study
Auditory Verbal Learning Test， VALT
Baseline neuropsychological performance
Time frame: Day 1 of entry study
Digit span test,DST
Baseline neuropsychological performance
Time frame: Day 1 of entry study
Digit Symbol Substitution Test, DSST
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）
Baseline peripheral blood neuropathology biomarkers level
Time frame: Blood samples will be collected on day 1 of the entry study
C-peptide（nmol/l）
Baseline peripheral blood neuropathology biomarkers level
Time frame: Blood samples will be collected on day 1 of the entry study
HbA1c（mmol/mol）
Baseline peripheral blood neuropathology biomarkers level
Time frame: Blood samples will be collected on day 1 of the entry study
blood lipid（mmol/L）
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）
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）
19 secondary outcomes
Longitudinal changes of brain structural MRI scan
Time frame: 36 months, 72 months
Longitudinal changes of brain functional MRI scan
Time frame: 36 months, 72 months
Longitudinal changes of brain diffusion tensor MRI scan
Time frame: 36 months, 72 months
Longitudinal changes of brain arterial spin labeling MRI scan
Time frame: 36 months, 72 months
Longitudinal changes of neuropsychological performance
Time frame: 36 months, 72 months
Longitudinal changes of neuropsychological performance
Time frame: 36 months, 72 months
Longitudinal changes of neuropsychological performance
Time frame: 36 months, 72 months
Longitudinal changes of neuropsychological performance
Time frame: 36 months, 72 months
Longitudinal changes of neuropsychological performance
Time frame: 36 months, 72 months
Longitudinal changes of neuropsychological performance
Time frame: 36 months, 72 months
Longitudinal changes of neuropsychological performance
Time frame: 36 months, 72 months
Longitudinal changes of neuropsychological performance
Time frame: 36 months, 72 months
Longitudinal changes of peripheral blood neuropathology biomarkers leve
Time frame: 36 months, 72 months
Longitudinal changes of peripheral blood neuropathology biomarkers leve
Time frame: 36 months, 72 months
Longitudinal changes of peripheral blood neuropathology biomarkers leve
Time frame: 36 months, 72 months
Longitudinal changes of peripheral blood neuropathology biomarkers leve
Time frame: 36 months, 72 months
Longitudinal changes of peripheral blood neuropathology biomarkers leve
Time frame: 36 months, 72 months
Longitudinal changes of peripheral blood neuropathology biomarkers leve
Time frame: 36 months, 72 months
Machine learning of multimodal MRI data
Time frame: 72 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wenqing Xia, PHD study chair
Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes and Insulin Resistance, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenqing Xia, PHD (+8617749597285, wen_qing_xia@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline brain structural MRI scan (time frame: Within 1 week after neuropsychological tests). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.