The Effect of Antihypertensive Drugs on the Retina in Type 1 Diabetes
Information source: University of Aarhus
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 1 Diabetes
Intervention: Amlodipine (Drug); Lisinopril (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: University of Aarhus Official(s) and/or principal investigator(s):
Toke Bek, MD, PhD, Principal Investigator, Affiliation: Aarhus university hospital, Dep. of ophthalmology
Per L Poulsen, MD, PhD, Principal Investigator, Affiliation: Aarhus University hospital, Dep. of endocrinology (M)
Overall contact:
Jesper MJ Mehlsen, MD, Phone: 89493250, Email: jmehl@akhphd.au.dk
Summary
The purpose of this study is to compare the effect of two antihypertensive drugs on retinal
vesseldiameter in young diabetics. We use the retinal vessel analyzer (RVA) to investigate
how the drugs affect vesseldiameter, when the subjects are exposed to an increase in
bloodpressure, induced by isometric muscle contraction. We also examine the effect of
flickering lights on retinal vessel diameter using the RVA.
Clinical Details
Official title: The Effect of Antihypertensive Drugs on Retinal Vessel Autoregulation in Young People With Type 1 Diabetes
Study design: Other, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Pharmacodynamics Study
Primary outcome: Vesseldiameter changes in arbitrary units as measured with th Retinal Vessel Analyzer
Secondary outcome: bloodpressure (mmHG)
Detailed description:
Diabetes is a leading course of blindness in the western part of the world. Diabetics develop
diabetic retinopathy which can progress to blindness. Diabetic retinopathy is associated with
an increase of bloodflow 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 diabetics. Somehow this is thought to be related to the development and
occurrence of the retinopathy.
We achieve app. 20% increase in bloodpressure when people lift a 2kg handweight for 3
minutes. In normal healthy subjects the retinal vessel will contract during this increase,
but trials have shown that the vessels of diabetics dilate. When the retina is exposed to
flickering lights, the metabolism increases and the vessels in normal 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) influences the
vesseldiameter response in subjects exposed to increased bloodpressure vs increased retinal
metabolism.
Eligibility
Minimum age: 18 Years.
Maximum age: 35 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Type 1 diabetic
- 18-35 years of age
- Simplex retinopathy at last screening
- 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
Locations and Contacts
Jesper MJ Mehlsen, MD, Phone: 89493250, Email: jmehl@akhphd.au.dk
Aarhus university hospital, Aarhus 8000, Denmark; Recruiting
Jesper MJ Mehlsen, MD, Phone: 89493250, Email: jmehl@akhphd.au.dk
Jesper MJ Mehlsen, MD, Sub-Investigator
Toke Bek, MD, PhD, Principal Investigator
Additional Information
Starting date: July 2006
Ending date: August 2009
Last updated: September 1, 2008
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