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Diameter Changes of Retinal Vessels During Hypoxia

Primary Purpose

Diabetes Mellitus Type 1, Diabetic Maculopathy

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

COX inhibitor

L-NG-monomethyl arginine citrate

COX inhibitor + L-NG-monomethyl arginine citrate

About this trial

This is an interventional basic science trial for Diabetes Mellitus Type 1

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Department of Ophthalmology, Aarhus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Hypoxia

Normoxia

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Diameter changes of retinal vessels

Comparing the differences of diameter changes occuring during each of the interventions.

Secondary Outcome Measures

Full Information

NCT ID

NCT01689090

First Posted

September 17, 2012

Last Updated

October 11, 2018

Sponsor

University of Aarhus

1. Study Identification

Unique Protocol Identification Number

NCT01689090

Brief Title

Diameter Changes of Retinal Vessels During Hypoxia

Official Title

Diameter Changes of Retinal Vessels During Hypoxia

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Completed

Study Start Date

November 2012 (undefined)

Primary Completion Date

March 2016 (Actual)

Study Completion Date

March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Aarhus

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus Type 1, Diabetic Maculopathy

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

58 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Hypoxia

Arm Type

Experimental

Arm Description

Arm Title

Normoxia

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

COX inhibitor

Other Intervention Name(s)

Eye drops voltaren 1 mg/ml

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

L-NG-monomethyl arginine citrate

Other Intervention Name(s)

L-NMMA

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

COX inhibitor + L-NG-monomethyl arginine citrate

Intervention Description

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

Primary Outcome Measure Information:

Title

Diameter changes of retinal vessels

Description

Comparing the differences of diameter changes occuring during each of the interventions.

Time Frame

Examination day 1 and 2

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Line Pedersen, MD

Organizational Affiliation

Aarhus University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Ophthalmology, Aarhus University Hospital

City

Aarhus

ZIP/Postal Code

8000

Country

Denmark

12. IPD Sharing Statement

Citations:

PubMed Identifier

28752370

Citation

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.

Results Reference

derived

PubMed Identifier

27270566

Citation

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.

Results Reference

derived

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Diameter Changes of Retinal Vessels During Hypoxia

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