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The Early Warning System for the Diabetic Encephalopathy

12 juli 2022 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Förväntat)

300

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Kina
    • Shaanxi
      • Xi'an, Shaanxi, Kina, 710032
        • Rekrytering
        • Tangdu Hospital
        • Kontakt:
          • Ying Yu, master
          • Telefonnummer: 029-18191260958
          • E-post: yqlmn@126.com

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

40 år till 65 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Testmetod

Sannolikhetsprov

Studera befolkning

prodromal diabetes and early diabetes

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
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.
Tidsram: 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 )

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
evaluation of obesity and the changes in the state of obesity at 2.5 years
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Tang-Du Hospital

Utredare

  • Studiestol: Guangbin Cui, professor, Tang-Du Hospital

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 april 2015

Primärt slutförande (Förväntat)

1 november 2025

Avslutad studie (Förväntat)

1 december 2026

Studieregistreringsdatum

Först inskickad

2 april 2015

Först inskickad som uppfyllde QC-kriterierna

14 april 2015

Första postat (Uppskatta)

17 april 2015

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

13 juli 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

12 juli 2022

Senast verifierad

1 juli 2022

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • TDLL-2014086

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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