| Trial ID: | L3708 |
| Source ID: | NCT06428968
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| Associated Drug: |
160 Units Nasal Insulin Spray
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| Title: |
Investigating the Insulin Resistance in Individuals With Type 2 Diabetes
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| Acronym: |
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| Status: |
RECRUITING
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| Study Results: |
NO
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| Results: |
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| Conditions: |
Type 2 Diabetes
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| Interventions: |
DRUG: 160 units nasal insulin spray
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| Outcome Measures: |
Primary: The difference of changes of brain cerebral blood flow by arterial spin labeling between type 2 diabetes and healthy volunteers., Whole brain cerebral blood flow (CBF) will be recorded by arterial spin labeling (ASL). the changes in CBF (c-CBF) before and after the application of 160 units nasal insulin spray of interventional participants will be calculated. The c-CBF is an index of central insulin response., Baseline|The difference of the level of insulin signaling in Extracellular Vesicles of neuronal origin isolated from blood between type 2 diabetes and healthy volunteers., Phosphorylated insulin receptor substrate 1 and its downstream mediators represent the state of neuronal insulin resistance, whose improvement means better insulin signaling. For individuals with type 2 diabetes mellitus and healthy volunteers, blood samples will be collected and stored at -80℃ at baseline. The NEVs isolation and biomarker measurements will be processed uniformly, and the difference of the level of insulin signaling between two groups will be used for exploring underlying mechanism of disease., Baseline|The difference of the score of the Measurement and Treatment Research to Improve Cognition in Schizophrenia Consensus Cognitive Battery between type 2 diabetes and healthy volunteers., The cognitive function of interventional participants will be assessed using the Measurement and Treatment Research to Improve Cognition in Schizophrenia Consensus Cognitive Battery. Evaluator convert raw scores to scale scores, then to normalized T scores. T scores of seven domains and composite score are further calculated. The difference of T scores between two groups will be used for evaluating cognitive function. (higher score means better function)., Baseline|The difference of c-fMRI between type 2 diabetes and healthy volunteers., The resting-state functional MRI(fMRI) will be conducted at fasting state and after the application of 160 units nasal insulin spray. For every participants, the changes in fMRI (c-fMRI) under the application of nasal insulin spray will be analysed. The c-fMRI between type 2 diabetes and healthy volunteers may reflect the underlying mechanism of disease., Baseline | Secondary: The difference of Diffusion Tensor Imaging scanned by MRI between type 2 diabetes and healthy volunteers, Diffusion Tensor Imaging (DTI) will be performed using diffusion-weighted echo planar imaging sequences. The analysis of DTI will be conducted to investigate the difference of brain structure and morphology between type 2 diabetes and healthy volunteers., Baseline
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| Sponsor/Collaborators: |
Sponsor: Central South University
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
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| Enrollment: |
30
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SCREENING
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| Start Date: |
2024-09-06
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| Completion Date: |
2025-06-30
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| Results First Posted: |
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| Last Update Posted: |
2024-09-19
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| Locations: |
Department of Psychiatry, National Clinical Research Center for Mental Disorders, and National Center for Mental Disorders, The Second Xiangya Hospital of Central South University, Changsha, Hunan, 410011, China
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| URL: |
https://clinicaltrials.gov/show/NCT06428968
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