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

June 22, 2009 updated by: University of Aarhus

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Vessel diameter changes in arbitrary units as measured with the Retinal Vessel Analyzer
Time Frame: 120,240,360,480,600,720 and at 840secs
120,240,360,480,600,720 and at 840secs

Secondary Outcome Measures

Outcome Measure
Time Frame
Blood pressure (mmHG)
Time Frame: 120,240,360,600,720,840 secs
120,240,360,600,720,840 secs
24 hour ambulatory blood pressure (mmHg)
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Velux Fonden

Investigators

  • 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)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

June 14, 2006

First Submitted That Met QC Criteria

June 14, 2006

First Posted (Estimate)

June 15, 2006

Study Record Updates

Last Update Posted (Estimate)

June 23, 2009

Last Update Submitted That Met QC Criteria

June 22, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Jmehl01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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