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Status unknownNCT01721811Updated Mar 11, 2015

Retinal Function in Relation to Transient or Chronic Challenges to Retinal Metabolism

An interventional study of Hyperoxia and Glucose in Healthy Individuals and Patients With Diabetes., sponsored by Glostrup University Hospital, Copenhagen. Status unknown at 1 site in Denmark. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-03-11.

Sponsored by Glostrup University Hospital, Copenhagen · Not applicable and Interventional

The sponsor has not verified this record recently (last verified Mar 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

The aim of the study is to investigate how the retina adapts to different metabolic challenges, e.g. chronic systemic hypoxia, hyperglycemia, special training conditions or diets as well as transient changes in the content of oxygen and glucose in the blood.

02

Conditions studied

  • Healthy Individuals
  • Patients With Diabetes.
03

In context

Lead sponsor

Glostrup University Hospital, Copenhagen is the lead sponsor of 104 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Healthy individuals

Inclusion Criteria:

  • Healthy volunteers.
  • No known systemic or ocular disease.

Exclusion Criteria:

  • Any systemic or ocular disease.

Patients with diabetes

Inclusion criteria:

  • Diabetes mellitus
  • No intraocular disease other than conditions attributable to diabetes.

Exclusion criteria:

  • Intraocular disease other than conditions attributable to diabetes.
  • Systemic conditions which might contraindicate hyperoxic stimulation.
05

Study design

Phase
Not applicable
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    Healthy

    Healthy study participanats

    Other: Hyperoxia · Other: Glucose

  • Experimental
    Diabetes

    Patients with diabetes

    Other: Hyperoxia · Other: Glucose

Interventions

  • OtherHyperoxia

    Also known as: Hyperoxia is achieved by short-term pure oxygen breathing.

  • OtherGlucose

    Also known as: Standardised oral glucose load.

06

What researchers measure

Primary outcomes

  1. Retinal vessel diameters during hyperoxia

    Measurement of retinal vessel diameters before, during and after hyperoxic stimulation.

    Time frame: Before hyperoxia, after 15 minutes of hyperoxia, 30 minutes after ending hyperoxia

  2. Retinal perfusion velocities during hyperoxia

    Measurement of retinal perfusion velocities before, during and after hyperoxic stimulation.

    Time frame: Before hyperoxia, after 15 minutes of hyperoxia, 30 minutes after ending hyperoxia

  3. Retinal oximetry during hyperoxia

    Measurement of retinal oximetry status before, during and after hyperoxic stimulation.

    Time frame: Before hyperoxia, after 15 minutes of hyperoxia, 30 minutes after ending hyperoxia

  4. Retinal vessel diameters during hyperglycemia

    Measurement of retinal vessel diameters before, during and after hyperglycemic stimulation.

    Time frame: Before glucose ingestion, every 30 minutes for 3 hours following oral glucose load

  5. Retinal perfusion during hyperglycemia

    Measurement of retinal perfusion velocities before, during and after hyperglycemic stimulation.

    Time frame: Before glucose ingestion, every 30 minutes for 3 hours following oral glucose load

  6. Retinal oximetry during hyperglycemia

    Measurement of retinal oximetry status before, during and after hyperglycemic stimulation.

    Time frame: Before glucose ingestion, every 30 minutes for 3 hours following oral glucose load

07

Study locations

1 of 1 sites recruiting
  • Department of Ophthalmology, Glostrup University Hospital
    Glostrup, 2600, Denmark
    • Oliver Klefter, MD · Contact · +45 38 63 48 18
    • Michael Larsen, Professor, DMSci · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 11, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01721811
Lead sponsor
Glostrup University Hospital, Copenhagen
Responsible party
Oliver Niels Klefter (MD, Glostrup University Hospital, Copenhagen) — Principal investigator
First posted
Nov 6, 2012
Start date
Oct 2012
Primary completion
Dec 2015 (estimated)
Last update
Mar 11, 2015

Study contacts

Oliver Klefter, MD
Contact
+45 38 63 48 18
Oliver Klefter, MD
principal investigator · Glostrup UH
Michael Larsen, Professor, DMSci
study director · Glostrup UH

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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