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

This study has been completed.
Sponsor:
Collaborator:
Velux Fonden
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00337298
First received: June 14, 2006
Last updated: June 22, 2009
Last verified: June 2009

June 14, 2006
June 22, 2009
July 2006
February 2009   (final data collection date for primary outcome measure)
Vessel diameter changes in arbitrary units as measured with the Retinal Vessel Analyzer [ Time Frame: 120,240,360,480,600,720 and at 840secs ] [ Designated as safety issue: No ]
vesseldiameters in arbitrary units
Complete list of historical versions of study NCT00337298 on ClinicalTrials.gov Archive Site
  • Blood pressure (mmHG) [ Time Frame: 120,240,360,600,720,840 secs ] [ Designated as safety issue: No ]
  • 24 hour ambulatory blood pressure (mmHg) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
bloodpressure
Not Provided
Not Provided
 
The Effect of Amlodipine and Lisinopril on Retinal Autoregulation in Type 1 Diabetes
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Type 1 Diabetes
  • Diabetic Retinopathy
  • Eye Diseases
  • Diabetes Complications
  • 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.
Experimental: 1
Crossover design. Arm is same all the way
Interventions:
  • Drug: Amlodipine
  • Drug: Lisinopril
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
February 2009
February 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 35 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00337298
Jmehl01
No
Toke Bek/Professor, Aarhus University Hospital
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)
University of Aarhus
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP