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

Sponsor:	University of Aarhus
Collaborator:	Velux foundation
Information provided by:	University of Aarhus
ClinicalTrials.gov Identifier:	NCT00337298

Purpose

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.

Condition	Intervention
Type 1 Diabetes Diabetic Retinopathy Eye Diseases Diabetes Complications	Drug: Amlodipine Drug: Lisinopril

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Pharmacodynamics Study
Official 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.

Resource links provided by NLM:

MedlinePlus related topics: Blood Pressure Medicines Diabetes Diabetes Complications Diabetes Type 1 Diabetic Eye Problems Eye Diseases Retinal Disorders

Drug Information available for: Lisinopril Amlodipine Amlodipine besylate

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	25
Study Start Date:	July 2006
Study Completion Date:	February 2009
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.

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.

Eligibility

Ages Eligible for Study:	18 Years to 35 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00337298

Locations

Denmark
Aarhus university hospital
Aarhus, Denmark, 8000

Sponsors and Collaborators

University of Aarhus

Velux foundation

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)

More Information

No publications provided

Responsible Party:	Aarhus University Hospital ( Toke Bek/Professor )
Study ID Numbers:	Jmehl01
Study First Received:	June 14, 2006
Last Updated:	June 22, 2009
ClinicalTrials.gov Identifier:	NCT00337298 History of Changes
Health Authority:	Denmark: Danish Medicines Agency

Keywords provided by University of Aarhus:

Diabetes
Retinopathy
Blood Pressure
Amlodipine
Lisinopril

Additional relevant MeSH terms:

Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Cardiotonic Agents
Physiological Effects of Drugs
Calcium Channel Blockers
Diabetic Angiopathies
Membrane Transport Modulators
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Diseases
Diabetes Complications
Retinal Diseases
Autoimmune Diseases
Metabolic Diseases
Immune System Diseases

Eye Diseases
Lisinopril
Vascular Diseases
Diabetes Mellitus
Endocrine System Diseases
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Protective Agents
Pharmacologic Actions
Protease Inhibitors
Amlodipine
Diabetic Retinopathy
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on November 27, 2009