Effekten af type 1-diabetes på pan-arteriel vaskulær funktion og insulinfølsomhed hos mennesker (EJB046)
12. januar 2016 opdateret af: Eugene Barrett, University of Virginia
Arteriel vaskulær sygdom er den vigtigste årsag til morbiditet og dødelighed for type 1-diabetespatienter (DM1).
Metabolisk insulinresistens (metIR), selv i fravær af hyperglykæmi, giver en 1,5 til 3 gange øget CVD-risiko i den generelle befolkning.
Metabolisk insulinresistens (MetIR) har gentagne gange vist sig at være udbredt hos voksne og unge med DM1.
MetIR i fedme og DM2 er ledsaget af vaskulær insulinresistens (vasIR), som er karakteriseret ved nedsat vasodilatatorisk virkning af insulin på resistens eller mikrovaskulære kar.
VasIR er ikke blevet systematisk undersøgt i DM1.
Vi antager, at DM1 hos unge voksne svækker både baseline og insulin-responsiv vaskulær funktion i hele den arterielle vaskulatur.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
I vores undersøgelse vil 20 raske kontrolpersoner blive sammenlignet med 20 DM1-patienter (18-40 år).
Vi vil vurdere funktion i conduit (pulsbølgehastighed-PWV, flow-medieret dilatation-FMD og augmentation index-AI), modstand (post-iskæmisk flowhastighed-PIFV) og hjerte- og skeletmuskulatur mikrovaskulære (kontrastforstærket ultralyd-CEU) kar før og efter 2 timer med en euglykæmisk insulinklemme.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
7
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Virginia
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Charlottesville, Virginia, Forenede Stater, 22903
- University of Virginia
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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
18 år til 40 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Type 1 diabetes sund kontrol
Beskrivelse
Inklusionskriterier:
- Alder 18-40
- BMI ≤ 25
- Sund uden kronisk sygdom (kun kontrolgruppe)
- Normale screeninglaboratorier eller ingen klinisk signifikante værdier
- DM1-personer vil have været på insulin i mindst 5 år og HbA1c <9
Ekskluderingskriterier:
- Førstegradsslægtning med type 1 eller 2 diabetes (kun for kontrolgruppe)
- Rygning i øjeblikket eller inden for de seneste 6 måneder
- Medicin, der påvirker vaskulaturen (undtagen ACE eller ARB hos DM1-personer, selvom de skal være ude af disse lægemidler i 2 uger før undersøgelsen).
- Forhøjet LDL-kolesterol > 160
- BP <100/60 eller >160/90
- Pulsoximetri <90 %
- Gravid eller ammende
- Anamnese med kardiovaskulær sygdom, cerebral vaskulær sygdom, perifer vaskulær sygdom, leversygdom
- Tilstedeværelse af en intrakardial eller intrapulmonal shunt (vi screener for dette ved auskultation under den fysiske undersøgelse).
- Kendt overfølsomhed over for perflutren (indeholdt i Definity)
For DM1 gruppe:
- HbA1c ≥ 9
- Mikroalbuminuri
- Retinipati
- Ketoacidose inden for det seneste år.
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 |
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Type 1 diabetiker
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Styring
normal sund kontrol
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Augmentation Index
Tidsramme: baseline
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vaskulær foranstaltning
|
baseline
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Pulsbølgehastighed
Tidsramme: baseline
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vaskulær foranstaltning
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baseline
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Flowmedieret dilatation
Tidsramme: Baseline
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vaskulær foranstaltning
|
Baseline
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Kontrastforstærket ultralyd
Tidsramme: baseline
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vaskulær foranstaltning
|
baseline
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Augmentation Index
Tidsramme: efter 2 timers insulinklemme
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vaskulær foranstaltning
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efter 2 timers insulinklemme
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Pulsbølgehastighed
Tidsramme: efter 2 timers insulinklemme
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vaskulær foranstaltning
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efter 2 timers insulinklemme
|
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Flowmedieret dilatation
Tidsramme: efter 2 timers insulinklemme
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vaskulær foranstaltning
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efter 2 timers insulinklemme
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Kontrastforstærket ultralyd
Tidsramme: efter 2 timers insulinklemme
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vaskulær foranstaltning
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efter 2 timers insulinklemme
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Eugene J. B, MD, PhD, University of Virginia
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
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- Llaurado G, Ceperuelo-Mallafre V, Vilardell C, Simo R, Freixenet N, Vendrell J, Gonzalez-Clemente JM. Arterial stiffness is increased in patients with type 1 diabetes without cardiovascular disease: a potential role of low-grade inflammation. Diabetes Care. 2012 May;35(5):1083-9. doi: 10.2337/dc11-1475. Epub 2012 Feb 22.
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. december 2014
Primær færdiggørelse (Faktiske)
1. juni 2015
Studieafslutning (Faktiske)
1. juni 2015
Datoer for studieregistrering
Først indsendt
1. juli 2015
Først indsendt, der opfyldte QC-kriterier
2. juli 2015
Først opslået (Skøn)
3. juli 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
13. januar 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. januar 2016
Sidst verificeret
1. januar 2016
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 17099
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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