Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00337298
Status:
COMPLETED
Last Update Posted:
2009-06-23
First Post:
2006-06-14
Brief Title:
The Effect of Amlodipine and Lisinopril on Retinal Autoregulation in Type 1 Diabetes
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2009-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None