The Early Warning System for the Diabetic Encephalopathy

Tang-Du Hospital

Status: Enrolling

Conditions: Mild Cognitive Impairment; Diabetes Mellitus Type 2; Metabolic Syndrome X

Study type: Observational

Funder types: Other

Identifiers

NCT02420470

TDLL-2014086

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 40 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

300 participants in 3 patient groups

healthy control group

Description:

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

prodromal diabetes group

Description:

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

diabetes group

Description:

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