The Effect of Amlodipine and Lisinopril on Retinal Autoregulation in Type 1 Diabetes
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|ClinicalTrials.gov Identifier: NCT00337298|
Recruitment Status : Completed
First Posted : June 15, 2006
Last Update Posted : June 23, 2009
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Diabetic Retinopathy Eye Diseases Diabetes Complications||Drug: Amlodipine Drug: Lisinopril||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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.|
|Study Start Date :||July 2006|
|Actual Primary Completion Date :||February 2009|
|Actual Study Completion Date :||February 2009|
Crossover design. Arm is same all the way
1 (5mg) tablet daily, given 14 days totally before measure of outcome.Drug: Lisinopril
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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00337298
|Aarhus university hospital|
|Aarhus, Denmark, 8000|
|Principal Investigator:||Toke Bek, MD, PhD||Aarhus university hospital, Dep. of ophthalmology|
|Principal Investigator:||Per L Poulsen, MD, PhD||Aarhus University hospital, Dep. of endocrinology (M)|