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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00337298
Recruitment Status : Completed
First Posted : June 15, 2006
Last Update Posted : June 23, 2009
Velux Fonden
Information provided by:
University of Aarhus

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Diabetic Retinopathy Eye Diseases Diabetes Complications Drug: Amlodipine Drug: Lisinopril Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: 1
Crossover design. Arm is same all the way
Drug: Amlodipine
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.

Primary Outcome Measures :
  1. Vessel diameter changes in arbitrary units as measured with the Retinal Vessel Analyzer [ Time Frame: 120,240,360,480,600,720 and at 840secs ]

Secondary Outcome Measures :
  1. Blood pressure (mmHG) [ Time Frame: 120,240,360,600,720,840 secs ]
  2. 24 hour ambulatory blood pressure (mmHg) [ Time Frame: 24 hours ]

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00337298

Aarhus university hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Velux Fonden
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)

Responsible Party: Toke Bek/Professor, Aarhus University Hospital Identifier: NCT00337298     History of Changes
Other Study ID Numbers: Jmehl01
First Posted: June 15, 2006    Key Record Dates
Last Update Posted: June 23, 2009
Last Verified: June 2009

Keywords provided by University of Aarhus:
Blood Pressure

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetes Complications
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Cardiotonic Agents
Protective Agents
Physiological Effects of Drugs