The Early Warning System for the Diabetic Encephalopathy
12 juillet 2022 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Description détaillée
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.
Type d'étude
Observationnel
Inscription (Anticipé)
300
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Guangbin Cui, professor
- E-mail: cgbtd@126.com
Lieux d'étude
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Shaanxi
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Xi'an, Shaanxi, Chine, 710032
- Recrutement
- Tangdu Hospital
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Contact:
- Ying Yu, master
- Numéro de téléphone: 029-18191260958
- E-mail: yqlmn@126.com
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
40 ans à 65 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon de probabilité
Population étudiée
prodromal diabetes and early diabetes
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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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.
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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evaluation of obesity and the changes in the state of obesity at 2.5 years
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chaise d'étude: Guangbin Cui, professor, Tang-Du Hospital
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 avril 2015
Achèvement primaire (Anticipé)
1 novembre 2025
Achèvement de l'étude (Anticipé)
1 décembre 2026
Dates d'inscription aux études
Première soumission
2 avril 2015
Première soumission répondant aux critères de contrôle qualité
14 avril 2015
Première publication (Estimation)
17 avril 2015
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
13 juillet 2022
Dernière mise à jour soumise répondant aux critères de contrôle qualité
12 juillet 2022
Dernière vérification
1 juillet 2022
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- TDLL-2014086
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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