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The Effect of Amlodipine and Lisinopril on Retinal Autoregulation in Type 1 Diabetes

Information source: University of Aarhus
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 1 Diabetes; Diabetic Retinopathy; Eye Diseases; Diabetes Complications

Intervention: Amlodipine (Drug); Lisinopril (Drug)

Phase: N/A

Status: Completed

Sponsored by: University of Aarhus

Official(s) and/or principal investigator(s):
Toke Bek, MD, PhD, Principal Investigator, Affiliation: Aarhus university hospital, Dep. of ophthalmology
Per L Poulsen, MD, PhD, Principal Investigator, Affiliation: Aarhus University hospital, Dep. of endocrinology (M)


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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Primary outcome: Vessel diameter changes in arbitrary units as measured with the Retinal Vessel Analyzer

Secondary outcome:

Blood pressure (mmHG)

24 hour ambulatory blood pressure (mmHg)

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.


Minimum age: 18 Years. Maximum age: 35 Years. Gender(s): Both.


Inclusion Criteria:

- Type 1 diabetes

- 18-35 years of age

- Simplex retinopathy at last screening (Less than 10 retinal haemorrhages at the

nearest ordinary screening examination)

- normotensive (BP not above 160 mmHg systolic or 100 mmHg diastolic)

Exclusion Criteria:

- Pregnancy

- Systolic Bloodpressure above 160 mmHg

- Diastolic bloodpressure above 100 mmHg

- Retinopathy grade higher than simplex retinopathy

- Prior retinal laser photocoagulation

Locations and Contacts

Aarhus university hospital, Aarhus 8000, Denmark
Additional Information

Starting date: July 2006
Last updated: June 22, 2009

Page last updated: August 23, 2015

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