Type 1 DiabetesNCT00337298
The Effect of Amlodipine and Lisinopril on Retinal Autoregulation in Type 1 Diabetes
A study testing Amlodipine and Lisinopril in people with Type 1 Diabetes and Diabetic Retinopathy, run by University of Aarhus at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Type 1 Diabetes, Diabetic Retinopathy, Eye Diseases
- What is being tested?
- Amlodipine and Lisinopril
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteDenmark
- Study dates
- Jul 2006to Feb 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- Pregnancy
- Systolic Bloodpressure above 160 mmHg
- Diastolic bloodpressure above 100 mmHg
- Retinopathy grade higher than simplex retinopathy
- Prior retinal laser photocoagulation
Trial locations and contacts
1 site in 1 country.
About this 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.
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.
Read the 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.
- Being tested
- Amlodipine, Lisinopril
- Keywords
- Diabetes, Retinopathy, Blood Pressure, Amlodipine, Lisinopril
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetic Retinopathy, Eye Diseases, Diabetes Complications, Diabetes Mellitus, Retinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmlodipineDrug
1 (5mg) tablet daily, given 14 days totally before measure of outcome.
LisinoprilDrug
Lisinopril 10 mg given daily for 14 days and then outcome was measured.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Crossover design. Arm is same all the way Receives: Drug: Amlodipine; Drug: Lisinopril |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vessel diameter changes in arbitrary units as measured with the Retinal Vessel Analyzer
Measured: 120,240,360,480,600,720 and at 840secs
Secondary outcomes (2)
Blood pressure (mmHG)
Measured: 120,240,360,600,720,840 secs
24 hour ambulatory blood pressure (mmHg)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2006 (estimated)
- Study startJul 2006
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Velux Fonden
- Investigators
- Toke Bek, MD, PhD, Principal investigator, Aarhus university hospital, Dep. of ophthalmologyPer L Poulsen, MD, PhD, Principal investigator, Aarhus University hospital, Dep. of endocrinology (M)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00337298
- Sponsor's protocol ID
- Jmehl01
- Status last verified
- Jun 2009
- First submitted
- 14 Jun 2006
- Last updated
- 23 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00337298
- Acronym / sponsor ID
- Jmehl01
- Keywords
- Diabetes, Retinopathy, Blood Pressure, Amlodipine, Lisinopril
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Velux Fonden
- Study start
- Jul 2006
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 15 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Amlodipine, Drug: LisinoprilCrossover design. Arm is same all the way |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- Pregnancy
- Systolic Bloodpressure above 160 mmHg
- Diastolic bloodpressure above 100 mmHg
- Retinopathy grade higher than simplex retinopathy
- Prior retinal laser photocoagulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amlodipine1 (5mg) tablet daily, given 14 days totally before measure of outcome. | Drug | 1 |
| LisinoprilLisinopril 10 mg given daily for 14 days and then outcome was measured. | Drug | 1 |
Primary outcome
Vessel diameter changes in arbitrary units as measured with the Retinal Vessel Analyzer
Time frame: 120,240,360,480,600,720 and at 840secs
2 secondary outcomes
Blood pressure (mmHG)
Time frame: 120,240,360,600,720,840 secs
24 hour ambulatory blood pressure (mmHg)
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Toke Bek, MD, PhD principal investigator
Aarhus university hospital, Dep. of ophthalmology
Per L Poulsen, MD, PhD principal investigator
Aarhus University hospital, Dep. of endocrinology (M)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amlodipine and Lisinopril in people with Type 1 Diabetes and Diabetic Retinopathy, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2009.