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The Early Warning System for the Diabetic Encephalopathy

12. juli 2022 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

300

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

40 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

prodromal diabetes and early diabetes

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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.
Tidsramme: 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 )

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
evaluation of obesity and the changes in the state of obesity at 2.5 years
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Tang-Du Hospital

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. april 2015

Primær færdiggørelse (Forventet)

1. november 2025

Studieafslutning (Forventet)

1. december 2026

Datoer for studieregistrering

Først indsendt

2. april 2015

Først indsendt, der opfyldte QC-kriterier

14. april 2015

Først opslået (Skøn)

17. april 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. juli 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. juli 2022

Sidst verificeret

1. juli 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • TDLL-2014086

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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