The Early Warning System for the Diabetic Encephalopathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-30

Study Completion Date

2026-12-31

Brief Summary

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Diabetes( mainly type II diabetes )lead to the central nervous system (CNS) function impairment, especially the mild cognitive impairment that increased the risk of progression to dementia.The primary objectives are defined according to a hierarchical design: i) to tailor and apply multi-parametric, functional MRI techniques to identify cerebral abnormalities (cerebral biomarkers) in type 2 diabetes mellitus and prodromal diabetes mellitus ; ii) to assess whether these cerebral biomarkers are associated with cognitive decrements;iii) to follow up with the putative prediabetic condition patients to verify whether they can transform into diabetes.

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Detailed Description

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Diabetes ( mainly type II diabetes ) lead to the central nervous system (CNS) function impairment, especially the mild cognitive impairment (MCI) that increased the risk of progression to dementia. It was regarded that neurodegeneration contributes to the diabetic MCI, however, recent research suggested that CNS microvascular alterations are the mechanism for early diabetic MCI. But there still lacks an early warning system for the CNS micro-structure alterations during early diabetes. Latest neuroimaging techniques enable the measurement of brain blood flow, local neural activity，and the nuclei deposition of iron to reflect CNS micro-structure alterations. But these techniques are complicated and can not fully reflect the alterations with one single technique.We previous observed that 44.4% of diabetic patients demonstrate MCI and established the comprehensive protocols of measuring brain blood flow, local neural activity and the nuclei deposition of iron simultaneously based on the multimodal MRI technique so as to reflect the microstructure alterations reliably and validly. Therefore, we intend to integrate psychological measurement and clinical biochemical examination, and to establish the early warning system for the central nervous system micro-structure alterations during early diabetes based on the multi-modal MRI technique. The reliability and validity of this system will be tested in the diabetic rat model. The early warning system will likely assist in screening patients with diabetic microstructure alterations, to perform early intervention so as to prevent or delay the progression from diabetic MCI to dementia.

Conditions

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Diabetes Mellitus Type 2 Mild Cognitive Impairment Metabolic Syndrome X

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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healthy control group

fasting plasma glucose(FPG)\<6.11mmol/L，and 2-h plasma glucose(2hPG)\<7.77mmol/L；

No interventions assigned to this group

prodromal diabetes group

IFG：fasting plasma glucose(FPG) ≥5.6mmol/L (100mg/dl)，and\<7.0mmol/L (126mg/dl)，oral glucose tolerance test(OGTT) 2-h plasma glucose(2hPG) \<7.8 mmol/L ；IGT：oral glucose tolerance test(OGTT) 2-h plasma glucose(2hPG) ≥7.8mmol/L (140mg/dl)，and\<11.1mmol/L (200mg/dl)，fasting plasma glucose(FPG)\< 5.6mmol/L

No interventions assigned to this group

diabetes group

fasting plasma glucose(FPG)\>7.0mmol/L, or 2-h plasma glucose(2hPG)\>11.1mmol/L

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* without dementia
* Inform Consent Form
* Education time more than 6 years
* blood glucose matches the group standard

Exclusion Criteria

* Pregnant woman
* suffer from serious brain disease
* Magnetic resonance contraindications
* lack of compliance
* image quality is too poor to deal with

Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes