Diabetic RetinopathyNCT00880139
Study Investigating the Levels and Effects of Low-grade Inflammation in Diabetic Retinopathy of Type 1 Diabetes
An observational study of Diabetic Retinopathy and Inflammation, run by Medical University of Vienna at 1 site in Austria.
Trial summary
There is much evidence that localized low grade inflammatory processes may contribute to the microvascular complications of type 1 and type 2 diabetes mellitus including sight-threatening diabetic retinopathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy, Inflammation
- What is being tested?
- Blood sampling, Noninvasive measurement of systemic hemodynamics and Visual acuity assessment
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 33 participants
- Where
- 1 siteAustria
- Study dates
- Jun 2009to Sep 2012
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: outpatients
Who may be able to join
- Patients with type 1 diabetes mellitus with duration of > 1 year
- Men and women, age ≥ 18, nonsmokers
- Body mass index between 16 and 30 kg/m²
- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant or diabetes-related
- Mild, moderate or severe non-proliferative diabetic retinopathy
Who cannot join
- Abuse of drugs or alcoholic beverages
- Participation in a clinical trial in the 3 weeks preceding the study
- Treatment with anti-inflammatory drugs in the 3 weeks before the study day
- Symptoms of a clinically relevant illness in the 3 weeks before the study day
- Blood donation or equivalent blood loss in the 3 weeks before the study day
- Other ocular pathologies than non-proliferative diabetic retinopathy
Show all 9Show fewer
- Ametropia > 6 dpt
- History or family history of epilepsy
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Clinical Pharmacology, Medical University of Vienna
Vienna
About this study
Official title: A Cross-sectional Study Investigating the Levels and Effects of Low-grade Inflammation in Diabetic Retinopathy of Type 1 Diabetes
There is much evidence that localized low grade inflammatory processes may contribute to the microvascular complications of type 1 and type 2 diabetes mellitus including sight-threatening diabetic retinopathy. Some biomarkers for inflammation have been found to be elevated in diabetes patients and correlations between those biomarkers and the severity of diabetic complications have been found in the last years. The relation between this low grade inflammation and the microvascular changes observed in diabetic retinopathy is, however, not well characterized.
In the present study patients with different stages of non-proliferative diabetic retinopathy will be included. Several markers of inflammation will be measured from blood samples. These markers will be related to vascular factors including flicker-induced vasodilatation as a marker of endothelial dysfunction and perifoveal leukocyte velocity and density as measured with the blue field entoptic phenomenon. In addition, the ophthalmologic status of the patients will be assessed according to the Modified Airlie House classification.
A multiple regression model will be employed to study the association between the different methods.
- Conditions
- Diabetic Retinopathy, Inflammation
- Being tested
- Blood sampling, Noninvasive measurement of systemic hemodynamics, Visual acuity assessment, Blue field entoptic technique (Blue field stimulator, BFS-2050), Ophthalmic examination and fundus photography
- Keywords
- Diabetes mellitus, type 1, Inflammation, Cytokines, Vascular reactivity
- Medical subject headings
- Diabetic Retinopathy, Inflammation, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingProcedure or surgery
Determination of cytokine plasma levels (ELISA)
Noninvasive measurement of systemic hemodynamicsProcedure or surgery
performed once
Visual acuity assessmentProcedure or surgery
ETDRS charts
Blue field entoptic technique (Blue field stimulator, BFS-2050)Device
Also called Blue field stimulator, BFS-2050
performed once
Ophthalmic examination and fundus photographyProcedure or surgery
7 + 1 standard fields
Retinal Vessel Analyzer (DVA)Device
Also called DVA
Assessment of retinal vessel reactivity to stimulation with flickering light
High resolution optical coherence tomography (OCT)Device
Also called OCT
performed once
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma biomarkers for inflammation (CRP, TNF-α, IL-6, vWF, e-Selektin)
Measured: 1 day
Perifoveal white cell blood flow (Blue field entoptic technique)
Measured: 1 day
Retinal vessel reactivity to flicker stimulation (Retinal Vessel Analyzer)
Measured: 1 day
Arteriolar to venous ratio
Measured: 1 day
Secondary outcomes (5)
Capillary blood glucose
Measured: 1 day
Stage of diabetic retinopathy
Measured: 1 day
Visual acuity
Measured: 1 day
Intraocular pressure
Measured: 1 day
Systolic/diastolic arterial blood pressure, pulse rate
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 posted13 Apr 2009 (estimated)
- Study startJun 2009
- Primary completionAug 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 33 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
- Berthold Pemp, MD, Principal investigator, Department of Clinical Pharmacology, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00880139
- Sponsor's protocol ID
- OPHT-171008
- Status last verified
- Nov 2014
- First submitted
- 18 Dec 2008
- Last updated
- 14 Nov 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-sectional Study Investigating the Levels and Effects of Low-grade Inflammation in Diabetic Retinopathy of Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT00880139
- Acronym / sponsor ID
- OPHT-171008
- Conditions
- Diabetic Retinopathy, Inflammation
- Keywords
- Diabetes mellitus, type 1, Inflammation, Cytokines, Vascular reactivity
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 13 Apr 2009 (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 much evidence that localized low grade inflammatory processes may contribute to the microvascular complications of type 1 and type 2 diabetes mellitus including sight-threatening diabetic retinopathy. Some biomarkers for inflammation have been found to be elevated in diabetes patients and correlations between those biomarkers and the severity of diabetic complications have been found in the last years. The relation between this low grade inflammation and the microvascular changes observed in diabetic retinopathy is, however, not well characterized.
In the present study patients with different stages of non-proliferative diabetic retinopathy will be included. Several markers of inflammation will be measured from blood samples. These markers will be related to vascular factors including flicker-induced vasodilatation as a marker of endothelial dysfunction and perifoveal leukocyte velocity and density as measured with the blue field entoptic phenomenon. In addition, the ophthalmologic status of the patients will be assessed according to the Modified Airlie House classification.
A multiple regression model will be employed to study the association between the different methods.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- outpatients
Key inclusion criteria (5 listed)
- Patients with type 1 diabetes mellitus with duration of > 1 year
- Men and women, age ≥ 18, nonsmokers
- Body mass index between 16 and 30 kg/m²
- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant or diabetes-related
- Mild, moderate or severe non-proliferative diabetic retinopathy
Key exclusion criteria (9 listed)
- Abuse of drugs or alcoholic beverages
- Participation in a clinical trial in the 3 weeks preceding the study
- Treatment with anti-inflammatory drugs in the 3 weeks before the study day
- Symptoms of a clinically relevant illness in the 3 weeks before the study day
- Blood donation or equivalent blood loss in the 3 weeks before the study day
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 |
|---|---|---|
| Blood samplingDetermination of cytokine plasma levels (ELISA) | Procedure or surgery | – |
| Noninvasive measurement of systemic hemodynamicsperformed once | Procedure or surgery | – |
| Visual acuity assessmentETDRS charts | Procedure or surgery | – |
| Blue field entoptic technique (Blue field stimulator, BFS-2050)Also: Blue field stimulator, BFS-2050performed once | Device | – |
| Ophthalmic examination and fundus photography7 + 1 standard fields | Procedure or surgery | – |
| Retinal Vessel Analyzer (DVA)Also: DVAAssessment of retinal vessel reactivity to stimulation with flickering light | Device | – |
| High resolution optical coherence tomography (OCT)Also: OCTperformed once | Device | – |
Primary outcome
Plasma biomarkers for inflammation (CRP, TNF-α, IL-6, vWF, e-Selektin)
Time frame: 1 day
Perifoveal white cell blood flow (Blue field entoptic technique)
Time frame: 1 day
Retinal vessel reactivity to flicker stimulation (Retinal Vessel Analyzer)
Time frame: 1 day
Arteriolar to venous ratio
Time frame: 1 day
5 secondary outcomes
Capillary blood glucose
Time frame: 1 day
Stage of diabetic retinopathy
Time frame: 1 day
Visual acuity
Time frame: 1 day
Intraocular pressure
Time frame: 1 day
Systolic/diastolic arterial blood pressure, pulse rate
Time frame: 1 day
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 14 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.
Berthold Pemp, 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?
An observational study of Diabetic Retinopathy and Inflammation, 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 5 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: stopped early, as of the sponsor's last update on 14 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?
Plasma biomarkers for inflammation (CRP, TNF-α, IL-6, vWF, e-Selektin) (time frame: 1 day). The study lists 4 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 14 Nov 2014.