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NCT Number: NCT02420470

The Early Warning System for the Diabetic Encephalopathy

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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Key information

Conditions

Diabetes Mellitus Type 2 Cognition Disorders Cognitive Dysfunction Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Mental Disorders Metabolic Diseases Metabolic Syndrome Metabolic Syndrome X Mild Cognitive Impairment Neurocognitive Disorders Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Prodromal Symptoms Signs and Symptoms

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

    Time frame: subjects will be assessed six times (once half a year, up to 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).

Secondary outcomes

  1. evaluation of obesity and the changes in the state of obesity at 2.5 years

    Time frame: subjects will be assessed six times (once half a year, up to 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.

  2. metabolic characteristics and their changes at 2.5 years

    Time frame: subjects will be assessed six times (once half a year, up to 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.

  3. Mental health and the changes in the scores of the scales at 2.5 years

    Time frame: subjects will be assessed six times (once half a year, up to 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.

  4. Lifestyle and its changes at 2.5 years

    Time frame: subjects will be assessed six times (once half a year, up to 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Guangbin Cui, professor

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Tang-Du Hospital

Other

Registry information

Official study title

The Early Warning System for the Central Nervous System Micro-structure Alterations During Early Diabetes Based on the Multi-mode MRIs

Important dates

Study start
2015
Primary completion
2025
Study completion
2026
First posted
Apr 17, 2015
Registry last updated
Jul 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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