Clinical trial NCT00712842: Neurovascular Coupling in Patients With Early Stage Diabetes Retinopathy
Official title: Neurovascular Coupling in Patients With Early Stage Diabetes Retinopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Retinopathy
Keywords: Diabetes
ocular blood flow
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2008-07-10
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 50 Patients with Diabetes Type 1 50 Healthy Control Subjects

Brief summary: A variety of studies demonstrate that ocular blood flow is altered in diabetes and retinal perfusion abnormalities have been proposed to contribute to the pathogenesis of diabetic retinopathy.

Various animal and human studies have demonstrated that retinal and optic nerve blood flow increase in response to diffuse luminance flicker. Based on studies with ERG, this effect has been attributed to augmented activity in the retinal ganglion cells and associated axons indicating a coupling mechanism between neuronal activity and retinal blood flow. Whereas a variety of studies describe the effects of flickering light on retinal and optic nerve head blood flow, the knowledge about this coupling in the diabetic retina is sparse.

In view of the fact that neural activity and blood flow are strongly coupled in the human retina, one could hypothesize that neurodegenerative changes in the retina could contribute to the vascular dysregulation and in turn lead to changes of ocular perfusion. The investigators set out to investigate whether the coupling of neural activity and blood flow is impaired in patients with early stage diabetic retinopathy compared to those in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Men and women aged between 20 and 50 years
* Normal findings in the medical history and physical examination 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 retinopathy. Patients with no signs of diabetic retinopathy (level 1) or patients with one or more microaneurysms (level 2) will be included. Duration of Diabetes is between 5 and 20 years
* Men and women will be included in equal parts. A pregnancy test will be performed at screening
* Ametropia of less than 3 diopters and anisometropia of less than 1 diopter

Exclusion Criteria:

* Non insulin dependent diabetes
* Maturity onset diabetes of the young (MODY diabetes)
* Any sign of non diabetes induced vascular pathologies, systemic hypertension (defined as systolic blood pressure \> 150 mm Hg and diastolic blood pressure \> 90 mm Hg.)
* Presence of intraocular pathology other than diabetic retinopathy
* History or family history of epilepsy
* Pregnancy

Primary outcomes:
measure: Intraocular pressure
timeFrame: 90 minutes
measure: Retinal arterial and venous diameter
timeFrame: 90 minutes
measure: Retinal blood velocity
timeFrame: 90 minutes
measure: Pattern ERG
timeFrame: measured once on the study day
Secondary outcomes:
measure: Mean arterial pressure
timeFrame: 90 minutes
measure: Blood glucose
timeFrame: measured once on the study day
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Clinical Pharmacology, Medical University of Vienna
Study officials:
References:
citation: Lasta M, Pemp B, Schmidl D, Boltz A, Kaya S, Palkovits S, Werkmeister R, Howorka K, Popa-Cherecheanu A, Garhofer G, Schmetterer L. Neurovascular dysfunction precedes neural dysfunction in the retina of patients with type 1 diabetes. Invest Ophthalmol Vis Sci. 2013 Jan 30;54(1):842-7. doi: 10.1167/iovs.12-10873.