An interventional study of Amlodipine and Lisinopril in Type 1 Diabetes, Diabetic Retinopathy and Eye Diseases, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2009-06-23.
Sponsored by University of Aarhus · Not applicable and Interventional
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.
815 studies on the registry are indexed under Retinal Diseases; 105 are open to participants now.
This study's enrollment of 25 is below the median of 60 across 500 interventional studies indexed under Retinal Diseases.
Browse Retinal Diseases studies →University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.
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Exclusion Criteria:
Crossover design. Arm is same all the way
Drug: Amlodipine · Drug: Lisinopril
1 (5mg) tablet daily, given 14 days totally before measure of outcome.
Lisinopril 10 mg given daily for 14 days and then outcome was measured.
Vessel diameter changes in arbitrary units as measured with the Retinal Vessel Analyzer
Time frame: 120,240,360,480,600,720 and at 840secs
Blood pressure (mmHG)
Time frame: 120,240,360,600,720,840 secs
24 hour ambulatory blood pressure (mmHg)
Time frame: 24 hours
This study is completed, as verified in Jun 2009. You cannot join it, but the record below documents what was studied.
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University of Aarhus