Diabetes Mellitus, Type 1NCT00432029
Correlation of Flicker Induced and Flow Mediated Vasodilatation in Patients With Endothelial Dysfunction and Healthy Volunteers.
A study testing Forearm blood flow measurement, Flow mediated dilation (FMD) and Zeiss Retinal Vessel Analyzer (RVA), Stimulation with Flicker-light in people with Diabetes Mellitus, Type 1 and Hypertension, run by Medical University of Vienna at 1 site in Austria.
Trial summary
A couple of studies have shown that illuminating the eye with diffuse flickering light is accompanied by an increase of retinal vessel diameters, optic nerve head blood flow and retinal blood flow. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 1, Hypertension, Hypercholesterolemia
- What is being tested?
- Forearm blood flow measurement, Flow mediated dilation (FMD) and Zeiss Retinal Vessel Analyzer (RVA), Stimulation with Flicker-light
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteAustria
- Study dates
- Dec 2006to Jan 2008
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with diabetic retinopathy:
- Men and women aged > 18 years.
- Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant.
- Inclusion criteria of patients are insulin dependent diabetes mellitus (IDDM) with non or mild non-proliferative diabetic retinopathy. Patients with no signs of diabetic retinopathy (level 1) or patients with one or more microaneurysms (level 2) will be included. Level of diabetic retinopathy will be assessed according to the criteria defined in the AREDS-study.(1991)
- serum cholesterol < 250 mg/dl (treated or untreated)
- Patients with mild hypertension and/or hypercholesterinemia:
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- Men and women aged > 18 years.
- mild essential hypertension defined as a blood pressure meeting the criterion of hypertension grade 1 of the World Health Organisation blood pressure classification
- systolic blood pressure between 140 and 159 mmHg and diastolic blood pressure between 90 and 99 mmHg and/or
- serum cholesterol > 250 mg/dl
- blood pressure will be measured at two different occasion in a sitting positions
- Healthy subjects:
- Men and women aged > 18 years.
- Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
- normal ocular findings
- serum cholesterol < 200 mg/dl
- systolic blood pressure between 110mmHg and 140mmHg
- diastolic blood pressure < 90 mmHg
Who cannot join
- Abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
- Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- Blood donation during the previous 3 weeks
- other ocular pathologies than diabetic retinopathy level 1 or 2
- History or family history of epilepsy
- Ametropy greater or equal than 3 dpt
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- systolic blood pressure < 100mmHg
- diastolic blood pressure < 75mmHg
- pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, 1090
About this study
Official title: Correlation of Flicker Induced and Flow Mediated Vasodilatation in Patients With Endothelial Dysfunction and Healthy Volunteers
A couple of studies have shown that illuminating the eye with diffuse flickering light is accompanied by an increase of retinal vessel diameters, optic nerve head blood flow and retinal blood flow. We have recently used this visual stimulation technique as a new and powerful tool for the non-invasive investigation of vascular reactivity. Additionally, we could show that this response is diminished in patients with vascular pathologies and that the response is dependent on nitric oxide, indicating that flicker induced vasodilatation may reflect endothelial dysfunction and may be a new approach to test endothelial function in vivo.
One of the most widely used method for the assessment of endothelial function is flow mediated dilatation (FMD). FMD has been shown to give a reliable estimate of vascular function in vivo. In the present study, we set out to compare the standard method for the evaluation of endothelial function, FMD, to flicker induced vasodilatation in the retina.
- Being tested
- Forearm blood flow measurement, Flow mediated dilation (FMD), Zeiss Retinal Vessel Analyzer (RVA), Stimulation with Flicker-light
- Keywords
- Flicker induced vasodilatation, Flow mediated vasodilatation, Forearm blood flow, Retinal vessel diameter, Endothelial dysfunction
- Medical subject headings
- Diabetes Mellitus, Type 1, Hypertension, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forearm blood flow measurement, Flow mediated dilation (FMD)Procedure or surgery
Forearm blood flow measurement: baseline 1 min, 3 min after inflation of cuff, 4 min after 0.8mg Nitroglycerin
Zeiss Retinal Vessel Analyzer (RVA), Stimulation with Flicker-lightDevice
Stimulation with Flicker-light: 1 min, measurement without flickering light 4 min after 0.8 mg Nitroglycerin
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | IDDM Receives: Procedure: Forearm blood flow measurement, Flow mediated dilation (FMD); Device: Zeiss Retinal Vessel Analyzer (RVA), Stimulation with Flicker-light |
| 2 | Other | Hypercholesterolemia and/or Hypertension Receives: Procedure: Forearm blood flow measurement, Flow mediated dilation (FMD); Device: Zeiss Retinal Vessel Analyzer (RVA), Stimulation with Flicker-light |
| 3 | Other | age/sex matched healthy control subjects Receives: Procedure: Forearm blood flow measurement, Flow mediated dilation (FMD); Device: Zeiss Retinal Vessel Analyzer (RVA), Stimulation with Flicker-light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal vessel diameters (Retinal vessel analyzer)
Measured: 8 min
Forearm Blood Flow
Measured: 8 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2007 (estimated)
- Study startDec 2006
- Primary completionDec 2007
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Michael Wolzt, MD, Principal investigator, Department of Clinical Pharmacology, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00432029
- Sponsor's protocol ID
- OPHT-180506
- Status last verified
- Jun 2008
- First submitted
- 5 Feb 2007
- Last updated
- 4 Jul 2008
- Results posted
- No
Publications
Pemp B, Garhofer G, Weigert G, Karl K, Resch H, Wolzt M, Schmetterer L. Reduced retinal vessel response to flicker stimulation but not to exogenous nitric oxide in type 1 diabetes. Invest Ophthalmol Vis Sci. 2009 Sep;50(9):4029-32. doi: 10.1167/iovs.08-3260. Epub 2009 Apr 15.
PubMed 19369238
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Flicker Induced and Flow Mediated Vasodilatation in Patients With Endothelial Dysfunction and Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00432029
- Acronym / sponsor ID
- OPHT-180506
- Keywords
- Flicker induced vasodilatation, Flow mediated vasodilatation, Forearm blood flow, Retinal vessel diameter, Endothelial dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 6 Feb 2007 (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.
A couple of studies have shown that illuminating the eye with diffuse flickering light is accompanied by an increase of retinal vessel diameters, optic nerve head blood flow and retinal blood flow. We have recently used this visual stimulation technique as a new and powerful tool for the non-invasive investigation of vascular reactivity. Additionally, we could show that this response is diminished in patients with vascular pathologies and that the response is dependent on nitric oxide, indicating that flicker induced vasodilatation may reflect endothelial dysfunction and may be a new approach to test endothelial function in vivo.
One of the most widely used method for the assessment of endothelial function is flow mediated dilatation (FMD). FMD has been shown to give a reliable estimate of vascular function in vivo. In the present study, we set out to compare the standard method for the evaluation of endothelial function, FMD, to flicker induced vasodilatation in the retina.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Procedure: Forearm blood flow measurement, Flow mediated dilation (FMD), Device: Zeiss Retinal Vessel Analyzer (RVA), Stimulation with Flicker-lightIDDM |
| 2 | Other | Procedure: Forearm blood flow measurement, Flow mediated dilation (FMD), Device: Zeiss Retinal Vessel Analyzer (RVA), Stimulation with Flicker-lightHypercholesterolemia and/or Hypertension |
| 3 | Other | Procedure: Forearm blood flow measurement, Flow mediated dilation (FMD), Device: Zeiss Retinal Vessel Analyzer (RVA), Stimulation with Flicker-lightage/sex matched healthy control subjects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Men and women aged > 18 years.
- Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant.
- Inclusion criteria of patients are insulin dependent diabetes mellitus (IDDM) with non or mild non-proliferative diabetic retinopathy. Patients with no signs of diabetic retinopathy (level 1) or patients with one or more microaneurysms (level 2) will be included. Level of diabetic retinopathy will be assessed according to the criteria defined in the AREDS-study.(1991)
- serum cholesterol < 250 mg/dl (treated or untreated)
- Men and women aged > 18 years.
Key exclusion criteria (9 listed)
- Abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
- Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- Blood donation during the previous 3 weeks
- other ocular pathologies than diabetic retinopathy level 1 or 2
- History or family history of epilepsy
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 |
|---|---|---|
| Forearm blood flow measurement, Flow mediated dilation (FMD)Forearm blood flow measurement: baseline 1 min, 3 min after inflation of cuff, 4 min after 0.8mg Nitroglycerin | Procedure or surgery | 1, 2, 3 |
| Zeiss Retinal Vessel Analyzer (RVA), Stimulation with Flicker-lightStimulation with Flicker-light: 1 min, measurement without flickering light 4 min after 0.8 mg Nitroglycerin | Device | 1, 2, 3 |
Primary outcome
Retinal vessel diameters (Retinal vessel analyzer)
Time frame: 8 min
Forearm Blood Flow
Time frame: 8 min
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 4 Jul 2008.
- Derived from this study: PubMed 19369238Pemp B, Garhofer G, Weigert G, Karl K, Resch H, Wolzt M, Schmetterer L. Reduced retinal vessel response to flicker stimulation but not to exogenous nitric oxide in type 1 diabetes. Invest Ophthalmol Vis Sci. 2009 Sep;50(9):4029-32. doi: 10.1167/iovs.08-3260. Epub 2009 Apr 15.
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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.
Michael Wolzt, MD principal investigator
Department of Clinical Pharmacology, Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Forearm blood flow measurement, Flow mediated dilation (FMD) and Zeiss Retinal Vessel Analyzer (RVA), Stimulation with Flicker-light in people with Diabetes Mellitus, Type 1 and Hypertension, run by Medical University of Vienna at 1 site in Austria.
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 18 inclusion and 9 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 4 Jul 2008. 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 Austria. 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?
Retinal vessel diameters (Retinal vessel analyzer) (time frame: 8 min). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00432029, which also lists 1 linked publication.
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 4 Jul 2008.