The Early Warning System for the Diabetic Encephalopathy
12 de julho de 2022 atualizado por: Tang-Du Hospital
The Early Warning System for the Central Nervous System Micro-structure Alterations During Early Diabetes Based on the Multi-mode MRIs
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.
Visão geral do estudo
Status
Recrutamento
Descrição detalhada
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.
Tipo de estudo
Observacional
Inscrição (Antecipado)
300
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Guangbin Cui, professor
- E-mail: cgbtd@126.com
Locais de estudo
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Shaanxi
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Xi'an, Shaanxi, China, 710032
- Recrutamento
- Tangdu Hospital
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Contato:
- Ying Yu, master
- Número de telefone: 029-18191260958
- E-mail: yqlmn@126.com
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
40 anos a 65 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra de Probabilidade
População do estudo
prodromal diabetes and early diabetes
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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healthy control group
fasting plasma glucose(FPG)<6.11mmol/L，and
2-h plasma glucose(2hPG)<7.77mmol/L；
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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
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diabetes group
fasting plasma glucose(FPG)>7.0mmol/L,
or 2-h plasma glucose(2hPG)>11.1mmol/L
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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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.
Prazo: subjects will be assessed six times (once half a year, up to 2.5 years )
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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).
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subjects will be assessed six times (once half a year, up to 2.5 years )
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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evaluation of obesity and the changes in the state of obesity at 2.5 years
Prazo: subjects will be assessed six times (once half a year, up to 2.5 years)
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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.
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subjects will be assessed six times (once half a year, up to 2.5 years)
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metabolic characteristics and their changes at 2.5 years
Prazo: subjects will be assessed six times (once half a year, up to 2.5 years)
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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.
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subjects will be assessed six times (once half a year, up to 2.5 years)
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Mental health and the changes in the scores of the scales at 2.5 years
Prazo: subjects will be assessed six times (once half a year, up to 2.5 years)
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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.
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subjects will be assessed six times (once half a year, up to 2.5 years)
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Lifestyle and its changes at 2.5 years
Prazo: subjects will be assessed six times (once half a year, up to 2.5 years)
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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.
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subjects will be assessed six times (once half a year, up to 2.5 years)
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Cadeira de estudo: Guangbin Cui, professor, Tang-Du Hospital
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
- 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.
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de abril de 2015
Conclusão Primária (Antecipado)
1 de novembro de 2025
Conclusão do estudo (Antecipado)
1 de dezembro de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
2 de abril de 2015
Enviado pela primeira vez que atendeu aos critérios de CQ
14 de abril de 2015
Primeira postagem (Estimativa)
17 de abril de 2015
Atualizações de registro de estudo
Última Atualização Postada (Real)
13 de julho de 2022
Última atualização enviada que atendeu aos critérios de controle de qualidade
12 de julho de 2022
Última verificação
1 de julho de 2022
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- TDLL-2014086
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