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

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ClinicalTrials.gov Identifier: NCT01721811
Recruitment Status : Unknown
Verified March 2015 by Oliver Niels Klefter, Glostrup University Hospital, Copenhagen.
Recruitment status was:  Recruiting
First Posted : November 6, 2012
Last Update Posted : March 11, 2015
Sponsor:
Information provided by (Responsible Party):
Oliver Niels Klefter, Glostrup University Hospital, Copenhagen

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Individuals Patients With Diabetes. Other: Hyperoxia Other: Glucose Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Retinal Function in Relation to Transient or Chronic Challenges to Retinal Metabolism
Study Start Date : October 2012
Estimated Primary Completion Date : December 2015

Arm Intervention/treatment
Experimental: Healthy
Healthy study participanats
Other: Hyperoxia
Other Name: Hyperoxia is achieved by short-term pure oxygen breathing.
Other: Glucose
Other Name: Standardised oral glucose load.
Experimental: Diabetes
Patients with diabetes
Other: Hyperoxia
Other Name: Hyperoxia is achieved by short-term pure oxygen breathing.
Other: Glucose
Other Name: Standardised oral glucose load.



Primary Outcome Measures :
  1. Retinal vessel diameters during hyperoxia [ Time Frame: Before hyperoxia, after 15 minutes of hyperoxia, 30 minutes after ending hyperoxia ]
    Measurement of retinal vessel diameters before, during and after hyperoxic stimulation.

  2. Retinal perfusion velocities during hyperoxia [ Time Frame: Before hyperoxia, after 15 minutes of hyperoxia, 30 minutes after ending hyperoxia ]
    Measurement of retinal perfusion velocities before, during and after hyperoxic stimulation.

  3. Retinal oximetry during hyperoxia [ Time Frame: Before hyperoxia, after 15 minutes of hyperoxia, 30 minutes after ending hyperoxia ]
    Measurement of retinal oximetry status before, during and after hyperoxic stimulation.

  4. Retinal vessel diameters during hyperglycemia [ Time Frame: Before glucose ingestion, every 30 minutes for 3 hours following oral glucose load ]
    Measurement of retinal vessel diameters before, during and after hyperglycemic stimulation.

  5. Retinal perfusion during hyperglycemia [ Time Frame: Before glucose ingestion, every 30 minutes for 3 hours following oral glucose load ]
    Measurement of retinal perfusion velocities before, during and after hyperglycemic stimulation.

  6. Retinal oximetry during hyperglycemia [ Time Frame: Before glucose ingestion, every 30 minutes for 3 hours following oral glucose load ]
    Measurement of retinal oximetry status before, during and after hyperglycemic stimulation.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01721811


Contacts
Contact: Oliver Klefter, MD +45 38 63 48 18

Locations
Denmark
Department of Ophthalmology, Glostrup University Hospital Recruiting
Glostrup, Denmark, 2600
Contact: Oliver Klefter, MD    +45 38 63 48 18      
Contact: Michael Larsen, Professor, DMSci         
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
Investigators
Principal Investigator: Oliver Klefter, MD Glostrup UH
Study Director: Michael Larsen, Professor, DMSci Glostrup UH

Responsible Party: Oliver Niels Klefter, MD, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier: NCT01721811     History of Changes
Other Study ID Numbers: Klefter2
First Posted: November 6, 2012    Key Record Dates
Last Update Posted: March 11, 2015
Last Verified: March 2015