NCT00718614|TerminatedDMC
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Sponsor study identifier
interventional
80
1 country
1
Study Start
June 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2007
Actual (reported)Study Completion
July 2007
Actual (reported)There is evidence from a variety of animal studies that choroidal blood flow is under neural control. Recent results in humans indicate that a light/dark transition is associated with a short lasting reduction in choroidal blood flow. Several observations indicate that the changes in choroidal perfusion are triggered at least in part by neural mechanisms. Particularly, we have shown that during unilateral dark/light transition both eyes react with choroidal vasoconstriction strongly indicating a neural mechanism for blood flow regulation. Investigation of changes in choroidal blood flow during light/dark transition may represent an interesting approach to study neural dysregulation at the level of the eye in patients with IDDM. Accordingly, the hypothesis of reduced choroidal blood flow responses to a light/dark transition in patient with IDDM will be tested. This response in choroidal blood flow will be correlated to parameters of diabetic neuropathy and diabetic retinopathy.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2007
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2007
Date type not reportedThis date has not been verified as actual or estimated.
July 2007
Actual (reported)July 2007
Actual (reported)July 7, 2008
Actual (reported)July 18, 2008
Actual (reported)fundus pulsation amplitude
3 hours
choroidal blood flow
3 hours
Nerve conduction velocity
measured before intervention
Pupil diameter during infra-red pupillometry
measured before intervention
heart rate variability
measured before intervention
Patients with long standing IDDM (\>10 years) and no diabetic retinopathy
Patients with long standing IDDM (\>10 years) and mild non-proliferative diabetic retinopathy
Patients with long standing IDDM (\>10 years) and moderate to severe non-proliferative diabetic retinopathy
Light will be switched from 0.5µW/cm2/sr to 115µW/cm2/sr.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Department of Clinical Pharmacology
Vienna, 1090, Austria
Gerhard Garhoefer, MD
Department of Clinical Pharmacology, Medical University of Vienna
First Submitted
July 7, 2008
First Posted
July 18, 2008
Study Start
June 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2007
healthy volunteers, matched for age and sex
Contact the study team to confirm eligibility.
Study Completion
July 2007
Actual (reported)Last Updated
November 25, 2014
Record last verified: 2014-11
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Source: ClinicalTrials.gov.
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