NCT01689090

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 20, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

October 16, 2018

Status Verified

August 1, 2015

Enrollment Period

3.3 years

First QC Date

September 17, 2012

Last Update Submit

October 11, 2018

Conditions

Diabetes Mellitus Type 1Diabetic Maculopathy

Outcome Measures

Primary Outcomes (1)

  • Diameter changes of retinal vessels

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

    Examination day 1 and 2

Study Arms (2)

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.

Other: COX inhibitorOther: L-NG-monomethyl arginine citrateOther: 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.

Other: COX inhibitorOther: L-NG-monomethyl arginine citrateOther: COX inhibitor + L-NG-monomethyl arginine citrate

Interventions

COX inhibitorOTHER

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

Also known as: Eye drops voltaren 1 mg/ml
HypoxiaNormoxia
L-NG-monomethyl arginine citrateOTHER

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

Also known as: L-NMMA
HypoxiaNormoxia
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

HypoxiaNormoxia

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diabetes type 1 without retinopathy
  • Diabetic retinopathy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology, Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Related Publications (2)

  • 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.

    PMID: 28752370DERIVED

  • 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.

    PMID: 27270566DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Cyclooxygenase Inhibitorsomega-N-Methylarginine

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Enzyme InhibitorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesAnti-Inflammatory Agents, Non-SteroidalAnalgesics, Non-NarcoticAnalgesicsSensory System AgentsPeripheral Nervous System AgentsPhysiological Effects of DrugsAnti-Inflammatory AgentsTherapeutic UsesAntirheumatic AgentsArginineAmino Acids, BasicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DiaminoAmino Acids, Essential

Study Officials

  • Line Pedersen, MD

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2012

First Posted

September 20, 2012

Study Start

November 1, 2012

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

October 16, 2018

Record last verified: 2015-08

Locations

DK(1)