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

Tracking Information

First Received Date ^ICMJE

June 14, 2006

Last Updated Date

June 22, 2009

Start Date ^ICMJE

July 2006

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

vesseldiameters in arbitrary units

Change History

Complete list of historical versions of study NCT00337298 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

bloodpressure

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

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.

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 Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Other, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Pharmacodynamics Study

Condition ^ICMJE

Type 1 Diabetes
Diabetic Retinopathy
Eye Diseases
Diabetes Complications

Intervention ^ICMJE

Drug: Amlodipine
Drug: Lisinopril

Study Arms / Comparison Groups

Experimental: Crossover design. Arm is same all the way

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2009

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 35 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT ID ^ICMJE

NCT00337298

Responsible Party

Toke Bek/Professor, Aarhus University Hospital

Study ID Numbers ^ICMJE

Jmehl01

Study Sponsor ^ICMJE

University of Aarhus

Collaborators ^ICMJE

Velux foundation

Investigators ^ICMJE

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)

Information Provided By

University of Aarhus

Verification Date

June 2009

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