Clinical trial NCT02420470: The Early Warning System for the Diabetic Encephalopathy
Official title: The Early Warning System for the Central Nervous System Micro-structure Alterations During Early Diabetes Based on the Multi-mode MRIs
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes Mellitus Type 2
Mild Cognitive Impairment
Metabolic Syndrome X
Keywords: diabetes
neural and vessel alteration
prodromal stage
Lead sponsor: Tang-Du Hospital
Sponsor class: OTHER
First posted: 2015-04-17
Enrollment: 300
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: prodromal diabetes and early diabetes

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Functional and structural connectivity relationships of multiple brain regions and biomarkers of brain alterations, and the changes in relationships and biomarkers at 2.5 years.
timeFrame: subjects will be assessed six times (once half a year, up to 2.5 years )
Secondary outcomes:
measure: evaluation of obesity and the changes in the state of obesity at 2.5 years
timeFrame: subjects will be assessed six times (once half a year, up to 2.5 years)
measure: metabolic characteristics and their changes at 2.5 years
timeFrame: subjects will be assessed six times (once half a year, up to 2.5 years)
measure: Mental health and the changes in the scores of the scales at 2.5 years
timeFrame: subjects will be assessed six times (once half a year, up to 2.5 years)
measure: Lifestyle and its changes at 2.5 years
timeFrame: subjects will be assessed six times (once half a year, up to 2.5 years)
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Tangdu Hospital
state: Shaanxi
Study officials:
affiliation: Tang-Du Hospital
name: Guangbin Cui, professor
role: STUDY_CHAIR
References:
citation: Hu B, Yan LF, Sun Q, Yu Y, Zhang J, Dai YJ, Yang Y, Hu YC, Nan HY, Zhang X, Heng CN, Hou JF, Liu QQ, Shao CH, Li F, Zhou KX, Guo H, Cui GB, Wang W. Disturbed neurovascular coupling in type 2 diabetes mellitus patients: Evidence from a comprehensive fMRI analysis. Neuroimage Clin. 2019;22:101802. doi: 10.1016/j.nicl.2019.101802. Epub 2019 Mar 27.
citation: Sun Q, Chen GQ, Wang XB, Yu Y, Hu YC, Yan LF, Zhang X, Yang Y, Zhang J, Liu B, Wang CC, Ma Y, Wang W, Han Y, Cui GB. Alterations of White Matter Integrity and Hippocampal Functional Connectivity in Type 2 Diabetes Without Mild Cognitive Impairment. Front Neuroanat. 2018 Mar 20;12:21. doi: 10.3389/fnana.2018.00021. eCollection 2018.
citation: Yu Y, Sun Q, Yan LF, Hu YC, Nan HY, Yang Y, Liu ZC, Wang W, Cui GB. Multimodal MRI for early diabetic mild cognitive impairment: study protocol of a prospective diagnostic trial. BMC Med Imaging. 2016 Aug 24;16(1):50. doi: 10.1186/s12880-016-0152-x.