The Early Warning System for the Diabetic Encephalopathy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-65
SponsorTang-Du Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
without dementia
Inform Consent Form
Education time more than 6 years
blood glucose matches the group standard
Disqualifiers
Pregnant woman
suffer from serious brain disease
Magnetic resonance contraindications
lack of compliance
Trial population
prodromal diabetes and early diabetes
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
300 Participants
are grouped into 3 trial groupsGroup A: healthy control group
Group B: prodromal diabetes group
Group C: diabetes group
Trial outcomes
Primary outcomes
1
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.
Differences in macro-structural and micro-structural between patients,prodromal group and healthy controls will be evaluated. These MRI measures include volumetric characteristics (e.g. hyper-intensities, white matter lesions, atrophy, cerebral microbleeds), quantitative measures (e.g. T2 relaxation times, mean diffusivity, fractional anisotropy, mean kurtosis), functional characteristics (e.g. activated regions, cerebral blood flow), network properties (e.g. functional and structural connectivity, graph-theoretical measures).
Time frame
subjects will be assessed six times (once half a year, up to 2.5 years )Secondary outcomes
1
evaluation of obesity and the changes in the state of obesity at 2.5 years
Simple evaluation of obesity will include: Body mass index will be calculated as the weight (kg) divided by the square of the height (m). Waist circumference (WC) will be taken as the minimum circumference between the umbilicus and xiphoid process and measured to the nearest 0.5 cm.
Time frame
subjects will be assessed six times (once half a year, up to 2.5 years)2
metabolic characteristics and their changes at 2.5 years
Simple metabolic characteristics will include: oral glucose tolerance test, C peptide releasing test and insulin releasing test will be assessed;homeostasis model assessment of insulin resistance，insulin secretion of homeostasis model assessment and homeostasis model assessment-β will be calculated. what's more, cardiovascular risk factors(e.g. albumin, creatinin, total cholesterol, LDL- and HDL-cholesterol, triglycerides, HbA1c) will be assessed.
Time frame
subjects will be assessed six times (once half a year, up to 2.5 years)3
Mental health and the changes in the scores of the scales at 2.5 years
To evaluate the mental health, a series of psychiatric evaluation scale(e.g. mini-mental state examination, Montreal Cognitive Assessment，Hamilton anxiety scale, self-rating depression scale, frontal assessment battery) will be assessed.
Time frame
subjects will be assessed six times (once half a year, up to 2.5 years)4
Lifestyle and its changes at 2.5 years
Lifestyle specifics, including alcohol consumption, smoking behavior and mobility and exercise habit will be obtained. At the same time, quality of life will be obtained through a questionnaire.
Time frame
subjects will be assessed six times (once half a year, up to 2.5 years)Sponsors and contacts
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Source ClinicalTrials.gov