Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Coupling of Neural Activity and Retinal Blood Flow in Diabetes

19. februar 2020 opdateret af: Gerhard Garhofer, Medical University of Vienna

The prevalence of diabetes is increasing and the management of the disease is nowadays considered a major challenge. Affected patients have increased mortality and morbidity as well as a significant drop in the quality of life. The complications of diabetes can be classified as microvascular (e.g. nephropathy, neuropathy or retinopathy) or macrovascular (e.g. cardiovascular or cerebrovascular).

Several large-scale epidemiologic studies indicating that wider retinal venous caliber is strongly associated with the fasting glucose level as well as with diabetes. Another retinal vascular abnormality that is associated with diabetes is an abnormal retinal vascular response to flicker stimulation. Retinal vessel dilatation in response to stimulation with diffuse flicker light occurs due to a phenomenon called neurovascular coupling. This means that increased activity of neurons is associated with an increased retinal metabolism. This leads to a release of endogenous vasodilator substances and increased blood flow. However, previous studies were limited by the fact that retinal vessel diameters and blood flow were not measured simultaneously.

The present study aims to investigate whether the response of retinal vessel diameters and blood flow velocities to flicker stimulation is altered in patients with diabetes. Both parameters will be measured in real time using Fourier Domain Doppler OCT.

Studieoversigt

Status

Afsluttet

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

1

Kontakter og lokationer

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

Studiesteder

      • Vienna, Østrig, 1090
        • Department of Clinical Pharmacology

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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

24 patients with early insulin dependent diabetes and no or mild non-proliferative retinopathy, non-smokers 24 age and sex matched healthy controls, non-smokers

Beskrivelse

Inclusion Criteria:

  • Men and women aged over 18 years, nonsmokers
  • Normal findings in the medical history (except diabetes) and physical examination unless the investigator considers an abnormality to be clinically irrelevant
  • normal laboratory findings (except diabetes associated parameters) unless the investigator considers the abnormality to be clinically irrelevant
  • normal ophthalmic findings (except mild diabetic retinopathy), Ametropia less than 6 diopters
  • inclusion criterion of patients is type I diabetes with non or mild non-proliferative retinopathy

Exclusion criteria

Any of the following will exclude a healthy subject from the study:

  • Regular use of vasoactive drugs
  • Abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
  • Symptoms of a clinically relevant illness in the 3 weeks before the first study day
  • Blood donation during the previous 3 weeks
  • History or presence of any ocular pathology
  • History or family history of epilepsy
  • Systemic hypertension defined as systolic blood pressure >150mmHg, diastolic blood pressure >90mmHg
  • Pregnancy

Any of the following will exclude a subject with diabetes from the study:

  • Presence of non-insulin dependent diabetes, maturity onset diabetes of the young (MODY diabetes)
  • History or presence of any other diabetes induced vascular pathologies or any other ocular condition other then diabetic retinopathy
  • Best corrected visual acuity <0.8
  • Previous laser photocoagulation treatment
  • Systemic hypertension defined as systolic blood pressure >150mmHg, diastolic blood pressure >90mmHg
  • History or family history of epilepsy
  • Abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
  • Symptoms of a clinically relevant illness in the 3 weeks before the first study day
  • Blood donation during the previous 3 weeks
  • Pregnancy

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
Diabetic retinopathy
Patients with early insulin dependent diabetes and no or mild non-proliferative retinopathy
healthy
healthy control subjects

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Retinal vessel diameters
Tidsramme: 18 months
18 months
Retinal blood flow velocities
Tidsramme: 18 months
18 months

Samarbejdspartnere og efterforskere

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

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 (Faktiske)

6. marts 2013

Primær færdiggørelse (Faktiske)

6. marts 2013

Studieafslutning (Faktiske)

6. marts 2013

Datoer for studieregistrering

Først indsendt

11. april 2011

Først indsendt, der opfyldte QC-kriterier

15. juni 2011

Først opslået (Skøn)

17. juni 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. februar 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. februar 2020

Sidst verificeret

1. februar 2020

Mere information

Begreber relateret til denne undersøgelse

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 .

Kliniske forsøg med Diabetisk retinopati

Abonner