Correlation of Flicker Induced and Flow Mediated Vasodilatation in Patients With Endothelial Dysfunction and Healthy Volunteers.
Correlation of Flicker Induced and Flow Mediated Vasodilatation in Patients With Endothelial Dysfunction and Healthy Volunteers
A couple of studies have shown that illuminating the eye with diffuse flickering light is accompanied by an increase of retinal vessel diameters, optic nerve head blood flow and retinal blood flow. We have recently used this visual stimulation technique as a new and powerful tool for the non-invasive investigation of vascular reactivity. Additionally, we could show that this response is diminished in patients with vascular pathologies and that the response is dependent on nitric oxide, indicating that flicker induced vasodilatation may reflect endothelial dysfunction and may be a new approach to test endothelial function in vivo.
One of the most widely used method for the assessment of endothelial function is flow mediated dilatation (FMD). FMD has been shown to give a reliable estimate of vascular function in vivo. In the present study, we set out to compare the standard method for the evaluation of endothelial function, FMD, to flicker induced vasodilatation in the retina.
Panoramica dello studio
Stato
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Vienna, Austria, 1090
- Department of Clinical Pharmacology, Medical University of Vienna
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
Patients with diabetic retinopathy:
- Men and women aged > 18 years.
- Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant.
- Inclusion criteria of patients are insulin dependent diabetes mellitus (IDDM) with non or mild non-proliferative diabetic retinopathy. Patients with no signs of diabetic retinopathy (level 1) or patients with one or more microaneurysms (level 2) will be included. Level of diabetic retinopathy will be assessed according to the criteria defined in the AREDS-study.(1991)
- serum cholesterol < 250 mg/dl (treated or untreated)
Patients with mild hypertension and/or hypercholesterinemia:
- Men and women aged > 18 years.
- mild essential hypertension defined as a blood pressure meeting the criterion of hypertension grade 1 of the World Health Organisation blood pressure classification
- systolic blood pressure between 140 and 159 mmHg and diastolic blood pressure between 90 and 99 mmHg and/or
- serum cholesterol > 250 mg/dl
- blood pressure will be measured at two different occasion in a sitting positions
Healthy subjects:
- Men and women aged > 18 years.
- Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
- normal ocular findings
- serum cholesterol < 200 mg/dl
- systolic blood pressure between 110mmHg and 140mmHg
- diastolic blood pressure < 90 mmHg
Exclusion Criteria:
- 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
- other ocular pathologies than diabetic retinopathy level 1 or 2
- History or family history of epilepsy
- Ametropy greater or equal than 3 dpt
- systolic blood pressure < 100mmHg
- diastolic blood pressure < 75mmHg
- pregnant or lactating women
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Diagnostico
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Altro: 1
IDDM
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Forearm blood flow measurement: baseline 1 min, 3 min after inflation of cuff, 4 min after 0.8mg Nitroglycerin
Stimulation with Flicker-light: 1 min, measurement without flickering light 4 min after 0.8 mg Nitroglycerin
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Altro: 2
Hypercholesterolemia and/or Hypertension
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Forearm blood flow measurement: baseline 1 min, 3 min after inflation of cuff, 4 min after 0.8mg Nitroglycerin
Stimulation with Flicker-light: 1 min, measurement without flickering light 4 min after 0.8 mg Nitroglycerin
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Altro: 3
age/sex matched healthy control subjects
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Forearm blood flow measurement: baseline 1 min, 3 min after inflation of cuff, 4 min after 0.8mg Nitroglycerin
Stimulation with Flicker-light: 1 min, measurement without flickering light 4 min after 0.8 mg Nitroglycerin
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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Retinal vessel diameters (Retinal vessel analyzer)
Lasso di tempo: 8 min
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8 min
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Forearm Blood Flow
Lasso di tempo: 8 min
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8 min
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Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Studiare le date dei record
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Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- OPHT-180506
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