Diabetes Mellitus, Type 1NCT00718614
Choroidal Blood Flow Changes During Dark/Light Transitions in Patients With Insulin-dependent Diabetes Mellitus (IDDM)
A study testing Light will be switched from 0.5µW/cm2/sr to 115µW/cm2/sr. in people with Diabetes Mellitus, Type 1 and Diabetic Retinopathy, run by Medical University of Vienna at 1 site in Austria.
Trial summary
There is evidence from a variety of animal studies that choroidal blood flow is under neural control. Recent results in humans indicate that a light/dark transition is associated with a short lasting reduction in choroidal blood flow. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 1, Diabetic Retinopathy
- What is being tested?
- Light will be switched from 0.5µW/cm2/sr to 115µW/cm2/sr.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteAustria
- Study dates
- Jun 2007to Jul 2007
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For healthy control subjects:
- Men and women aged over 18 years, matched in regard to age, sex and smoking status
- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
- Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant
- Normal ophthalmic findings, Ametropia < 3 dpt for healthy control subjects
- For patients with IDDM:
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- Men and women aged over 18 years
- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
- Long standing IDDM > 10 years
- Mild or moderate to severe non-proliferative diabetic retinopathy (defined according to the MAHC)
- Ametropia < 3 dpt
Who cannot join
- Any of the following will exclude a healthy subject from the study:
- Regular use of vasoactive medication with may interfere with the study procedure, 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
- Any of the following will exclude a patient with IDDM from the study:
- Evidence of any relevant retinal or choroidal disease (Glaucoma, age related macula degeneration, cataract, history of central retinal artery obstruction or central retinal vein thrombosis)
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- Ophthalmological surgery (history of photo laser coagulation, including argon laser trabeculoplasty (ALT), trabeculectomy, deep sclerectomy)
- History of intravitreal injection with anti-proliferative therapy
- Need for dialysis
- Non-treated systemic hypertension (SPB>150, DBP>95)
- Evidence of coronary heart disease, cardiomyopathy, stenocardia, congestive heart failure, peripheral occlusive vascular disease, cardiac autonomic neuropathy
- Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- Blood donation during the previous 3 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Choroidal Blood Flow Changes During Dark/Light Transitions in Patients With IDDM
There is evidence from a variety of animal studies that choroidal blood flow is under neural control. Recent results in humans indicate that a light/dark transition is associated with a short lasting reduction in choroidal blood flow. Several observations indicate that the changes in choroidal perfusion are triggered at least in part by neural mechanisms. Particularly, we have shown that during unilateral dark/light transition both eyes react with choroidal vasoconstriction strongly indicating a neural mechanism for blood flow regulation. Investigation of changes in choroidal blood flow during light/dark transition may represent an interesting approach to study neural dysregulation at the level of the eye in patients with IDDM. Accordingly, the hypothesis of reduced choroidal blood flow responses to a light/dark transition in patient with IDDM will be tested. This response in choroidal blood flow will be correlated to parameters of diabetic neuropathy and diabetic retinopathy.
- Conditions
- Diabetes Mellitus, Type 1, Diabetic Retinopathy
- Being tested
- Light will be switched from 0.5µW/cm2/sr to 115µW/cm2/sr.
- Keywords
- Choroidal blood flow, Laser Doppler flowmetry, Diabetic Retinopathy, Diabetic Neuropathy
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetic Retinopathy, Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Light will be switched from 0.5µW/cm2/sr to 115µW/cm2/sr.Procedure or surgery
Light will be switched from 0.5µW/cm2/sr to 115µW/cm2/sr.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Patients with long standing IDDM (>10 years) and no diabetic retinopathy Receives: Procedure: Light will be switched from 0.5µW/cm2/sr to 115µW/cm2/sr. |
| 2 | Other | Patients with long standing IDDM (>10 years) and mild non-proliferative diabetic retinopathy Receives: Procedure: Light will be switched from 0.5µW/cm2/sr to 115µW/cm2/sr. |
| 3 | Other | Patients with long standing IDDM (>10 years) and moderate to severe non-proliferative diabetic retinopathy Receives: Procedure: Light will be switched from 0.5µW/cm2/sr to 115µW/cm2/sr. |
| 4 | Other | healthy volunteers, matched for age and sex Receives: Procedure: Light will be switched from 0.5µW/cm2/sr to 115µW/cm2/sr. |
What is being measured
The primary outcome is the main question the study is designed to answer.
fundus pulsation amplitude
Measured: 3 hours
choroidal blood flow
Measured: 3 hours
Secondary outcomes (3)
Nerve conduction velocity
Measured: measured before intervention
Pupil diameter during infra-red pupillometry
Measured: measured before intervention
heart rate variability
Measured: measured before intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2008 (estimated)
- Study startJun 2007
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
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
- NCT00718614
- Sponsor's protocol ID
- OPHT-300505-2
- Status last verified
- Nov 2014
- First submitted
- 7 Jul 2008
- Last updated
- 25 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Choroidal Blood Flow Changes During Dark/Light Transitions in Patients With IDDM
- ClinicalTrials.gov ID
- NCT00718614
- Acronym / sponsor ID
- OPHT-300505-2
- Conditions
- Diabetes Mellitus, Type 1, Diabetic Retinopathy
- Keywords
- Choroidal blood flow, Laser Doppler flowmetry, Diabetic Retinopathy, Diabetic Neuropathy
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 18 Jul 2008 (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.
There is evidence from a variety of animal studies that choroidal blood flow is under neural control. Recent results in humans indicate that a light/dark transition is associated with a short lasting reduction in choroidal blood flow. Several observations indicate that the changes in choroidal perfusion are triggered at least in part by neural mechanisms. Particularly, we have shown that during unilateral dark/light transition both eyes react with choroidal vasoconstriction strongly indicating a neural mechanism for blood flow regulation. Investigation of changes in choroidal blood flow during light/dark transition may represent an interesting approach to study neural dysregulation at the level of the eye in patients with IDDM. Accordingly, the hypothesis of reduced choroidal blood flow responses to a light/dark transition in patient with IDDM will be tested. This response in choroidal blood flow will be correlated to parameters of diabetic neuropathy and diabetic retinopathy.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Procedure: Light will be switched from 0.5µW/cm2/sr to 115µW/cm2/sr.Patients with long standing IDDM (>10 years) and no diabetic retinopathy |
| 2 | Other | Procedure: Light will be switched from 0.5µW/cm2/sr to 115µW/cm2/sr.Patients with long standing IDDM (>10 years) and mild non-proliferative diabetic retinopathy |
| 3 | Other | Procedure: Light will be switched from 0.5µW/cm2/sr to 115µW/cm2/sr.Patients with long standing IDDM (>10 years) and moderate to severe non-proliferative diabetic retinopathy |
| 4 | Other | Procedure: Light will be switched from 0.5µW/cm2/sr to 115µW/cm2/sr.healthy volunteers, matched for age and sex |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Men and women aged over 18 years, matched in regard to age, sex and smoking status
- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
- Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant
- Normal ophthalmic findings, Ametropia < 3 dpt for healthy control subjects
- Men and women aged over 18 years
Key exclusion criteria (13 listed)
- Regular use of vasoactive medication with may interfere with the study procedure, 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
- Evidence of any relevant retinal or choroidal disease (Glaucoma, age related macula degeneration, cataract, history of central retinal artery obstruction or central retinal vein thrombosis)
- Ophthalmological surgery (history of photo laser coagulation, including argon laser trabeculoplasty (ALT), trabeculectomy, deep sclerectomy)
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 |
|---|---|---|
| Light will be switched from 0.5µW/cm2/sr to 115µW/cm2/sr.Light will be switched from 0.5µW/cm2/sr to 115µW/cm2/sr. | Procedure or surgery | 1, 2, 3, 4 |
Primary outcome
fundus pulsation amplitude
Time frame: 3 hours
choroidal blood flow
Time frame: 3 hours
3 secondary outcomes
Nerve conduction velocity
Time frame: measured before intervention
Pupil diameter during infra-red pupillometry
Time frame: measured before intervention
heart rate variability
Time frame: measured before intervention
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2014.
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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 Light will be switched from 0.5µW/cm2/sr to 115µW/cm2/sr. in people with Diabetes Mellitus, Type 1 and Diabetic Retinopathy, 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 11 inclusion and 13 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: stopped early, as of the sponsor's last update on 25 Nov 2014. 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 was stopped early. Results are not available in the source record.
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?
fundus pulsation amplitude (time frame: 3 hours). 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?
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 25 Nov 2014; AzTrials last refreshed its copy on 4 Nov 2026.