Diameter Changes of Retinal Vessels During Hypoxia

NCT ID: NCT01689090

Last Updated: 2018-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2016-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus Type 1 Diabetic Maculopathy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Hypoxia

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.

Group Type EXPERIMENTAL

COX inhibitor

Intervention Type OTHER

Administration of 1 drop voltaren 45 minutes before recordings of diameter changes of retinal vessels are initiated

L-NG-monomethyl arginine citrate

Intervention Type OTHER

Intravenous administration of L-NMMA during recordings of diameter changes of retinal vessels

COX inhibitor + L-NG-monomethyl arginine citrate

Intervention Type OTHER

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

Normoxia

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.

Group Type EXPERIMENTAL

COX inhibitor

Intervention Type OTHER

Administration of 1 drop voltaren 45 minutes before recordings of diameter changes of retinal vessels are initiated

L-NG-monomethyl arginine citrate

Intervention Type OTHER

Intravenous administration of L-NMMA during recordings of diameter changes of retinal vessels

COX inhibitor + L-NG-monomethyl arginine citrate

Intervention Type OTHER

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

Interventions

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COX inhibitor

Administration of 1 drop voltaren 45 minutes before recordings of diameter changes of retinal vessels are initiated

Intervention Type OTHER

L-NG-monomethyl arginine citrate

Intravenous administration of L-NMMA during recordings of diameter changes of retinal vessels

Intervention Type OTHER

COX inhibitor + L-NG-monomethyl arginine citrate

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

Intervention Type OTHER

Other Intervention Names

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Eye drops voltaren 1 mg/ml L-NMMA

Eligibility Criteria

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Inclusion Criteria

* Diabetes type 1 without retinopathy
* Diabetic retinopathy

Exclusion Criteria

* 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Line Pedersen, MD

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Locations

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Department of Ophthalmology, Aarhus University Hospital

Aarhus, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 28752370 (View on PubMed)

Petersen 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.

Reference Type DERIVED
PMID: 27270566 (View on PubMed)

Other Identifiers

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HypNOCOX

Identifier Type: -

Identifier Source: org_study_id

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