The Early Warning System for the Diabetic Encephalopathy
12 luglio 2022 aggiornato da: 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.
Panoramica dello studio
Stato
Reclutamento
Descrizione dettagliata
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 di studio
Osservativo
Iscrizione (Anticipato)
300
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Guangbin Cui, professor
- Email: cgbtd@126.com
Luoghi di studio
-
-
Shaanxi
-
Xi'an, Shaanxi, Cina, 710032
- Reclutamento
- Tangdu Hospital
-
Contatto:
- Ying Yu, master
- Numero di telefono: 029-18191260958
- Email: yqlmn@126.com
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 40 anni a 65 anni (Adulto, Adulto più anziano)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione di probabilità
Popolazione di studio
prodromal diabetes and early diabetes
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
|---|
|
healthy control group
fasting plasma glucose(FPG)<6.11mmol/L，and
2-h plasma glucose(2hPG)<7.77mmol/L；
|
|
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
|
|
diabetes group
fasting plasma glucose(FPG)>7.0mmol/L,
or 2-h plasma glucose(2hPG)>11.1mmol/L
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
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.
Lasso di tempo: 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).
|
subjects will be assessed six times (once half a year, up to 2.5 years )
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
evaluation of obesity and the changes in the state of obesity at 2.5 years
Lasso di tempo: 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.
|
subjects will be assessed six times (once half a year, up to 2.5 years)
|
|
metabolic characteristics and their changes at 2.5 years
Lasso di tempo: 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.
|
subjects will be assessed six times (once half a year, up to 2.5 years)
|
|
Mental health and the changes in the scores of the scales at 2.5 years
Lasso di tempo: 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.
|
subjects will be assessed six times (once half a year, up to 2.5 years)
|
|
Lifestyle and its changes at 2.5 years
Lasso di tempo: 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.
|
subjects will be assessed six times (once half a year, up to 2.5 years)
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Cattedra di studio: Guangbin Cui, professor, Tang-Du Hospital
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 aprile 2015
Completamento primario (Anticipato)
1 novembre 2025
Completamento dello studio (Anticipato)
1 dicembre 2026
Date di iscrizione allo studio
Primo inviato
2 aprile 2015
Primo inviato che soddisfa i criteri di controllo qualità
14 aprile 2015
Primo Inserito (Stima)
17 aprile 2015
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
13 luglio 2022
Ultimo aggiornamento inviato che soddisfa i criteri QC
12 luglio 2022
Ultimo verificato
1 luglio 2022
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- TDLL-2014086
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .