The Early Warning System for the Diabetic Encephalopathy
2022年7月12日 更新者：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.
研究概览
详细说明
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.
研究类型
观察性的
注册 (预期的)
300
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Guangbin Cui, professor
- 邮箱：cgbtd@126.com
学习地点
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Shaanxi
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Xi'an、Shaanxi、中国、710032
- 招聘中
- Tangdu Hospital
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接触：
- Ying Yu, master
- 电话号码：029-18191260958
- 邮箱：yqlmn@126.com
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
40年 至 65年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
取样方法
概率样本
研究人群
prodromal diabetes and early diabetes
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
|---|
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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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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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.
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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evaluation of obesity and the changes in the state of obesity at 2.5 years
大体时间：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
大体时间：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
大体时间：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
大体时间：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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Guangbin Cui, professor、Tang-Du Hospital
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2015年4月1日
初级完成 (预期的)
2025年11月1日
研究完成 (预期的)
2026年12月1日
研究注册日期
首次提交
2015年4月2日
首先提交符合 QC 标准的
2015年4月14日
首次发布 (估计)
2015年4月17日
研究记录更新
最后更新发布 (实际的)
2022年7月13日
上次提交的符合 QC 标准的更新
2022年7月12日
最后验证
2022年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.