Diabetes Mellitus Type 1NCT01689090
Diameter Changes of Retinal Vessels During Hypoxia
A study testing COX inhibitor, L-NG-monomethyl arginine citrate and COX inhibitor + L-NG-monomethyl arginine citrate in people with Diabetes Mellitus Type 1 and Diabetic Maculopathy, run by University of Aarhus at 1 site in Denmark.
Trial summary
The primary objective is to study if an inhibition of nitric oxide and/or prostaglandins affect the diameter changes of retinal vessels observed during hypoxia. Diameter changes are studied using the Dynamic Vessel Analyzer. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus Type 1, Diabetic Maculopathy
- What is being tested?
- COX inhibitor, L-NG-monomethyl arginine citrate and COX inhibitor + L-NG-monomethyl arginine citrate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2012to Mar 2016
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diabetes type 1 without retinopathy
- Diabetic retinopathy
Who cannot join
- Cardio-vascular disease
- Lung disease
- Pregnancy
- Previous ocular disease other than retinal branch vein occlusion
- Previous treatment with medications influencing on the intraocular pressure or the metabolism of nitric oxide or prostaglandins
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Ophthalmology, Aarhus University Hospital
Aarhus, 8000
About this study
The primary objective is to study if an inhibition of nitric oxide and/or prostaglandins affect the diameter changes of retinal vessels observed during hypoxia. Diameter changes are studied using the Dynamic Vessel Analyzer.
- Conditions
- Diabetes Mellitus Type 1, Diabetic Maculopathy
- Being tested
- COX inhibitor, L-NG-monomethyl arginine citrate, COX inhibitor + L-NG-monomethyl arginine citrate
- 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.
COX inhibitorOther
Also called Eye drops voltaren 1 mg/ml
Administration of 1 drop voltaren 45 minutes before recordings of diameter changes of retinal vessels are initiated
L-NG-monomethyl arginine citrateOther
Also called L-NMMA
Intravenous administration of L-NMMA during recordings of diameter changes of retinal vessels
COX inhibitor + L-NG-monomethyl arginine citrateOther
Combination of interventions. Administration of an eye drop voltaren and 45 minutes later infusion with L-NMMA is started and recording of diameter changes of retinal vessels is performed
| Study group | Role | What they receive |
|---|---|---|
| Hypoxia | Experimental | Inhaling hypoxic gas mixture to induce hypoxemia during recordings of diameter changes of retinal vessels. Recording are performed during hypoxia alone and in combination with the associated interventions at two examination days. Receives: Other: COX inhibitor; Other: L-NG-monomethyl arginine citrate; Other: COX inhibitor + L-NG-monomethyl arginine citrate |
| Normoxia | Experimental | Breathing atmospheric air during recordings of diameter changes of retinal vessels. Recording are performed during normoxia alone and in combination with the associated interventions at two examination days. Receives: Other: COX inhibitor; Other: L-NG-monomethyl arginine citrate; Other: COX inhibitor + L-NG-monomethyl arginine citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diameter changes of retinal vessels
Comparing the differences of diameter changes occuring during each of the interventions.
Measured: Examination day 1 and 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2012 (estimated)
- Study startNov 2012
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus Type 1Studies of the same condition, open and under way.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Line Pedersen, MD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01689090
- Sponsor's protocol ID
- HypNOCOX
- Status last verified
- Aug 2015
- First submitted
- 17 Sep 2012
- Last updated
- 16 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Petersen L, Bek T. Post-hypoxic constriction of retinal arterioles is impaired during nitric oxide and cyclo-oxygenase inhibition and in diabetic patients without retinopathy. Graefes Arch Clin Exp Ophthalmol. 2017 Oct;255(10):1965-1971. doi: 10.1007/s00417-017-3746-2. Epub 2017 Jul 27.
PubMed 28752370Petersen L, Bek T. The diameter response of retinal arterioles in diabetic maculopathy is reduced during hypoxia and is unaffected by the inhibition of cyclo-oxygenase and nitric oxide synthesis. Graefes Arch Clin Exp Ophthalmol. 2016 Dec;254(12):2339-2346. doi: 10.1007/s00417-016-3399-6. Epub 2016 Jun 7.
PubMed 27270566
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diameter Changes of Retinal Vessels During Hypoxia
- ClinicalTrials.gov ID
- NCT01689090
- Acronym / sponsor ID
- HypNOCOX
- Conditions
- Diabetes Mellitus Type 1, Diabetic Maculopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 20 Sep 2012 (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 primary objective is to study if an inhibition of nitric oxide and/or prostaglandins affect the diameter changes of retinal vessels observed during hypoxia. Diameter changes are studied using the Dynamic Vessel Analyzer.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypoxia | Experimental | Other: COX inhibitor, Other: L-NG-monomethyl arginine citrate, Other: COX inhibitor + L-NG-monomethyl arginine citrateInhaling hypoxic gas mixture to induce hypoxemia during recordings of diameter changes of retinal vessels. Recording are performed during hypoxia alone and in combination with the associated interventions at two examination days. |
| Normoxia | Experimental | Other: COX inhibitor, Other: L-NG-monomethyl arginine citrate, Other: COX inhibitor + L-NG-monomethyl arginine citrateBreathing atmospheric air during recordings of diameter changes of retinal vessels. Recording are performed during normoxia alone and in combination with the associated interventions at two examination days. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diabetes type 1 without retinopathy
- Diabetic retinopathy
Key exclusion criteria (5 listed)
- Cardio-vascular disease
- Lung disease
- Pregnancy
- Previous ocular disease other than retinal branch vein occlusion
- Previous treatment with medications influencing on the intraocular pressure or the metabolism of nitric oxide or prostaglandins
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 |
|---|---|---|
| COX inhibitorAlso: Eye drops voltaren 1 mg/mlAdministration of 1 drop voltaren 45 minutes before recordings of diameter changes of retinal vessels are initiated | Other | Hypoxia, Normoxia |
| L-NG-monomethyl arginine citrateAlso: L-NMMAIntravenous administration of L-NMMA during recordings of diameter changes of retinal vessels | Other | Hypoxia, Normoxia |
| COX inhibitor + L-NG-monomethyl arginine citrateCombination of interventions. Administration of an eye drop voltaren and 45 minutes later infusion with L-NMMA is started and recording of diameter changes of retinal vessels is performed | Other | Hypoxia, Normoxia |
Primary outcome
Diameter changes of retinal vessels
Time frame: Examination day 1 and 2
Comparing the differences of diameter changes occuring during each of the interventions.
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 16 Oct 2018.
- Derived from this study: PubMed 28752370Petersen L, Bek T. Post-hypoxic constriction of retinal arterioles is impaired during nitric oxide and cyclo-oxygenase inhibition and in diabetic patients without retinopathy. Graefes Arch Clin Exp Ophthalmol. 2017 Oct;255(10):1965-1971. doi: 10.1007/s00417-017-3746-2. Epub 2017 Jul 27.
- Derived from this study: PubMed 27270566Petersen L, Bek T. The diameter response of retinal arterioles in diabetic maculopathy is reduced during hypoxia and is unaffected by the inhibition of cyclo-oxygenase and nitric oxide synthesis. Graefes Arch Clin Exp Ophthalmol. 2016 Dec;254(12):2339-2346. doi: 10.1007/s00417-016-3399-6. Epub 2016 Jun 7.
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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.
Line Pedersen, MD principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COX inhibitor, L-NG-monomethyl arginine citrate and COX inhibitor + L-NG-monomethyl arginine citrate in people with Diabetes Mellitus Type 1 and Diabetic Maculopathy, 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 2 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 16 Oct 2018. 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?
Diameter changes of retinal vessels (time frame: Examination day 1 and 2). 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 NCT01689090, which also lists 2 linked publications.
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 16 Oct 2018.