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NCT Number: NCT00337298

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

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetic Angiopathies Diabetic Retinopathy Endocrine System Diseases Eye Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases Retinal Diseases Vascular Diseases

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus university hospital

Aarhus, 8000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amlodipine

Drug

1 (5mg) tablet daily, given 14 days totally before measure of outcome.

Lisinopril

Drug

Lisinopril 10 mg given daily for 14 days and then outcome was measured.

Primary outcomes

  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 outcomes

  1. Blood pressure (mmHG)

    Time frame: 120,240,360,600,720,840 secs

  2. 24 hour ambulatory blood pressure (mmHg)

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Velux Fonden

Registry information

Official study 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.

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Jun 15, 2006
Registry last updated
Jun 23, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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