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

This study is currently recruiting participants.
Verified November 2012 by Glostrup University Hospital, Copenhagen
Sponsor:
Information provided by (Responsible Party):
Oliver Niels Klefter, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier:
NCT01721811
First received: October 31, 2012
Last updated: November 2, 2012
Last verified: November 2012
History of Changes
  Purpose

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 Intervention
Healthy Individuals
Patients With Diabetes.
 Other: Hyperoxia
Other: Glucose

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Retinal Function in Relation to Transient or Chronic Challenges to Retinal Metabolism

Resource links provided by NLM:

Drug Information available for: Dextrose
U.S. FDA Resources

Further study details as provided by Glostrup University Hospital, Copenhagen:

Primary Outcome Measures:
  • Retinal vessel diameters during hyperoxia [ Time Frame: Before hyperoxia, after 15 minutes of hyperoxia, 30 minutes after ending hyperoxia ] [ Designated as safety issue: No ]
    Measurement of retinal vessel diameters before, during and after hyperoxic stimulation.

  • Retinal perfusion velocities during hyperoxia [ Time Frame: Before hyperoxia, after 15 minutes of hyperoxia, 30 minutes after ending hyperoxia ] [ Designated as safety issue: No ]
    Measurement of retinal perfusion velocities before, during and after hyperoxic stimulation.

  • Retinal oximetry during hyperoxia [ Time Frame: Before hyperoxia, after 15 minutes of hyperoxia, 30 minutes after ending hyperoxia ] [ Designated as safety issue: No ]
    Measurement of retinal oximetry status before, during and after hyperoxic stimulation.

  • Retinal vessel diameters during hyperglycemia [ Time Frame: Before glucose ingestion, every 30 minutes for 3 hours following oral glucose load ] [ Designated as safety issue: No ]
    Measurement of retinal vessel diameters before, during and after hyperglycemic stimulation.

  • Retinal perfusion during hyperglycemia [ Time Frame: Before glucose ingestion, every 30 minutes for 3 hours following oral glucose load ] [ Designated as safety issue: No ]
    Measurement of retinal perfusion velocities before, during and after hyperglycemic stimulation.

  • Retinal oximetry during hyperglycemia [ Time Frame: Before glucose ingestion, every 30 minutes for 3 hours following oral glucose load ] [ Designated as safety issue: No ]
    Measurement of retinal oximetry status before, during and after hyperglycemic stimulation.


Estimated Enrollment: 120
Study Start Date: October 2012
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Oliver Niels Klefter, MD, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier: NCT01721811     History of Changes
Other Study ID Numbers: Klefter2
Study First Received: October 31, 2012
Last Updated: November 2, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

ClinicalTrials.gov processed this record on May 16, 2013