Type I DiabetesNCT01843114
Measurement of Total Retinal Blood Flow in Patients With Diabetes and Healthy Subjects
A study testing FDOCT and Dynamic Vessel Analyzer in people with Type I Diabetes, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The prevalence of diabetes and diabetes-associated complications is still increasing. Several major long-term complications of diabetes such as cardiovascular disease, chronic renal failure, diabetic retinopathy and others relate to the damage of blood vessels. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type I Diabetes
- What is being tested?
- FDOCT and Dynamic Vessel Analyzer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteAustria
- Study dates
- 12 Jan 2015to 1 Mar 2017
- 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
- Men and women aged over 18 years
- Non-smokers
- Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
- Normal ophthalmic findings, ametropia < 6 Dpt.
- Men and women aged over 18 years
- Non-smokers
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- Previously diagnosed type I diabetes
- No or mild non-proliferative diabetic retinopathy
- Normal ophthalmic findings except mild diabetic retinopathy, ametropia < 6 Dpt.
Who cannot join
- Any of the following will exclude a healthy subject from the study:
- Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- Presence or history of a severe medical condition as judged by the clinical investigator
- Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study (except oral contraceptive)
- Arterial hypertension (defined as either systolic blood pressure >145 mmHg or diastolic blood pressure >90 mmHg)
- Blood donation during the previous three weeks
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- Presence of any abnormalities preventing reliable measurements in the study eye as judged by the investigator
- Best corrected visual acuity < 0.8 Snellen
- Ametropia >= 6 Dpt
- Pregnancy, planned pregnancy or lactating
- Any of the following will exclude a patient with diabetes from the study:
- Participation in a clinical trial in the 3 weeks preceding the screening visit
- Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- Presence or history of a severe medical condition, except diabetes, as judged by the clinical investigator
- Arterial hypertension (defined as either systolic blood pressure >145 mmHg or diastolic blood pressure >90 mmHg)
- Blood donation during the previous three weeks
- Moderate to severe non-proliferative or proliferative diabetic retinopathy
- Previous laser photocoagulation treatment
- Presence of any abnormalities preventing reliable measurements in the study eye as judged by the investigator
- Best corrected visual acuity < 0.8 Snellen
- Ametropia >= 6 Dpt
- Pregnancy, planned pregnancy or lactating
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Clinical Pharmacology
Vienna, State of Vienna, 1090
About this study
The prevalence of diabetes and diabetes-associated complications is still increasing. Several major long-term complications of diabetes such as cardiovascular disease, chronic renal failure, diabetic retinopathy and others relate to the damage of blood vessels. Given that the eye provides the unique possibility in the human body to directly visualize blood vessels, much interest has been directed towards studying the ocular circulation. Although data of large epidemiological studies indicate that changes in retinal vessel caliber reflect other diabetes related factors, such as fasting glucose levels, there is still conflicting evidence on blood flow alterations in patients with diabetes. This is also related to the fact that up to now, methodological difficulties aggravate the assessment of blood flow changes in the retina in larger groups of patients. In the present study we propose to overcome this problem by using a technique called bi-directional Fourier Domain Doppler Optical Coherence Tomography (FDOCT), which we have developed in the recent years to measure retinal blood velocities. This technique allows for the non-invasive investigation of blood flow changes in human retina and will help us to better understand diabetes related vascular changes. The present study will use this technique to assess retinal blood flow changes in patients with diabetes and healthy subjects.
- Conditions
- Type I Diabetes
- Being tested
- FDOCT, Dynamic Vessel Analyzer
- Keywords
- Retinal blood flow, Retinal vessel diameter, Fourier Domain Optical Coherence Tomography, Retinal blood velocities
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDOCTDevice
Also called Fourier Domain Color Doppler Optical Coherence Tomography
Measurement of retinal blood velocities
Dynamic Vessel AnalyzerOther
Measurement of retinal vessel diameters
| Study group | Role | What they receive |
|---|---|---|
| Patients with Type I Diabetes | Other | 24 patients with type I diabetes with no or mild non-proliferative retinopathy Receives: Device: FDOCT; Other: Dynamic Vessel Analyzer |
| Healthy subjects | Other | 24 healthy age-and sex- matched control subjects Receives: Device: FDOCT; Other: Dynamic Vessel Analyzer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total retinal blood flow
Measurement of total retinal blood flow using the Dynamic Vessel Analyzer and Optical Coherence Tomography
Measured: 1 day
Secondary outcomes (2)
Retinal vessel diameter
Measurement of retinal vessel diameter using the Dynamic Vessel Analyzer
Measured: 1 day
Retinal blood velocities
Measurement of retinal blood flow velocities using Fourier Domain Optical Coherence Tomography
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2013 (estimated)
- Study start12 Jan 2015
- Primary completion26 Aug 2016
- Study completion1 Mar 2017
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 Type I DiabetesStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerhard Garhofer, Medical University of Vienna
- Investigators
- Gerhard Garhoefer, MD, Principal investigator, Department of Clinical Pharmacology, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01843114
- Sponsor's protocol ID
- OPHT-280113
- Status last verified
- Mar 2017
- First submitted
- 26 Apr 2013
- Last updated
- 21 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fondi K, Wozniak PA, Howorka K, Bata AM, Aschinger GC, Popa-Cherecheanu A, Witkowska KJ, Hommer A, Schmidl D, Werkmeister RM, Garhofer G, Schmetterer L. Retinal oxygen extraction in individuals with type 1 diabetes with no or mild diabetic retinopathy. Diabetologia. 2017 Aug;60(8):1534-1540. doi: 10.1007/s00125-017-4309-0. Epub 2017 May 25.
PubMed 28547132
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Total Retinal Blood Flow in Patients With Diabetes and Healthy Subjects
- ClinicalTrials.gov ID
- NCT01843114
- Acronym / sponsor ID
- OPHT-280113
- Conditions
- Type I Diabetes
- Keywords
- Retinal blood flow, Retinal vessel diameter, Fourier Domain Optical Coherence Tomography, Retinal blood velocities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 12 Jan 2015 (actual)
- Primary completion
- 26 Aug 2016 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 30 Apr 2013 (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 prevalence of diabetes and diabetes-associated complications is still increasing. Several major long-term complications of diabetes such as cardiovascular disease, chronic renal failure, diabetic retinopathy and others relate to the damage of blood vessels. Given that the eye provides the unique possibility in the human body to directly visualize blood vessels, much interest has been directed towards studying the ocular circulation. Although data of large epidemiological studies indicate that changes in retinal vessel caliber reflect other diabetes related factors, such as fasting glucose levels, there is still conflicting evidence on blood flow alterations in patients with diabetes. This is also related to the fact that up to now, methodological difficulties aggravate the assessment of blood flow changes in the retina in larger groups of patients. In the present study we propose to overcome this problem by using a technique called bi-directional Fourier Domain Doppler Optical Coherence Tomography (FDOCT), which we have developed in the recent years to measure retinal blood velocities. This technique allows for the non-invasive investigation of blood flow changes in human retina and will help us to better understand diabetes related vascular changes. The present study will use this technique to assess retinal blood flow changes in patients with diabetes and healthy subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Type I Diabetes | Other | Device: FDOCT, Other: Dynamic Vessel Analyzer24 patients with type I diabetes with no or mild non-proliferative retinopathy |
| Healthy subjects | Other | Device: FDOCT, Other: Dynamic Vessel Analyzer24 healthy age-and sex- matched control subjects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Men and women aged over 18 years
- Non-smokers
- Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
- Normal ophthalmic findings, ametropia < 6 Dpt.
- Men and women aged over 18 years
Key exclusion criteria (22 listed)
- Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- Presence or history of a severe medical condition as judged by the clinical investigator
- Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study (except oral contraceptive)
- Arterial hypertension (defined as either systolic blood pressure >145 mmHg or diastolic blood pressure >90 mmHg)
- Blood donation during the previous three weeks
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 |
|---|---|---|
| FDOCTAlso: Fourier Domain Color Doppler Optical Coherence TomographyMeasurement of retinal blood velocities | Device | Healthy subjects, Patients with Type I Diabetes |
| Dynamic Vessel AnalyzerMeasurement of retinal vessel diameters | Other | Healthy subjects, Patients with Type I Diabetes |
Primary outcome
Total retinal blood flow
Time frame: 1 day
Measurement of total retinal blood flow using the Dynamic Vessel Analyzer and Optical Coherence Tomography
2 secondary outcomes
Retinal vessel diameter
Time frame: 1 day
Retinal blood velocities
Time frame: 1 day
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 21 Mar 2017.
- Derived from this study: PubMed 28547132Fondi K, Wozniak PA, Howorka K, Bata AM, Aschinger GC, Popa-Cherecheanu A, Witkowska KJ, Hommer A, Schmidl D, Werkmeister RM, Garhofer G, Schmetterer L. Retinal oxygen extraction in individuals with type 1 diabetes with no or mild diabetic retinopathy. Diabetologia. 2017 Aug;60(8):1534-1540. doi: 10.1007/s00125-017-4309-0. Epub 2017 May 25.
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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.
Gerhard Garhoefer, 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 FDOCT and Dynamic Vessel Analyzer in people with Type I Diabetes, 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 9 inclusion and 22 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 21 Mar 2017. 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?
Total retinal blood flow (time frame: 1 day). 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 NCT01843114, 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 21 Mar 2017.