The Effect of Amlodipine and Lisinopril on Retinal Autoregulation in Type 1 Diabetes
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| 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 |
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| Original Secondary Outcome Measures ICMJE |
bloodpressure | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) | Experimental: 1
Crossover design. Arm is same all the way
Interventions:
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 25 | ||||||||
| Completion Date | February 2009 | ||||||||
| Primary Completion Date | February 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 35 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Denmark | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00337298 | ||||||||
| Other Study ID Numbers ICMJE | Jmehl01 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Toke Bek/Professor, Aarhus University Hospital | ||||||||
| Study Sponsor ICMJE | University of Aarhus | ||||||||
| Collaborators ICMJE | Velux Fonden | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of Aarhus | ||||||||
| Verification Date | June 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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