Type 1 Diabetes Clinical Trial
Official title:
Lack of Effect of Antihypertensive Treatment With Amlodipine and Lisinopril on Retinal Autoregulation in Patients With Type 1 Diabetes and Mild Diabetic Retinopathy. A Prospective Randomized Clinical Trial.
The purpose of this study is to compare the effect of two antihypertensive drugs on retinal vessel diameter in young type 1 diabetics. The retinal vessel analyzer (RVA) was used to investigate how the drugs affected vessel diameter, when the subjects were exposed to an increase in blood pressure, induced by isometric muscle contraction and when they were stimulated by flickering light.
Diabetes is a leading cause of blindness in the western part of the world. Diabetic patients
develop diabetic retinopathy which can progress to blindness. Diabetic retinopathy is
associated with an increase of blood flow in the retinal vessels, ischaemia in the periphery
and macular oedema. It has been shown in previous trials, that the pressure and metabolic
autoregulation is disturbed in patients with diabetes, and it is believed to contribute to
the development of diabetic retinopathy.
In healthy subjects the retinal arterioles will contract during an increase in blood
pressure, but trials have shown that this response is impaired in diabetics. When the retina
is exposed to flickering lights, the metabolism increase and the arterioles in healthy
subjects dilates. In diabetics this dilation is impaired. In this trial we want to
investigate if an ACE-inhibitor (lisinopril) or calcium channel blocker (amlodipine)
influence this response in subjects exposed to increased blood pressure vs increased retinal
metabolism.
;
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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