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

Not Applicable

• Conditions: Patients With Diabetes.; Healthy Individuals
• Interventions: Other: Hyperoxia; Other: Glucose

• Registration Number: NCT01721811
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-31
• Study First Submitted QC: 2012-11-02
• Study First Posted: 2012-11-06
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-10
• Last Update Posted: 2015-03-11
• Primary Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy	Glucose	Healthy study participanats
Healthy	Hyperoxia	Healthy study participanats
Diabetes	Hyperoxia	Patients with diabetes
Diabetes	Glucose	Patients with diabetes

Primary Outcome Measures

Name	Time	Method
Retinal vessel diameters during hyperoxia	Before hyperoxia, after 15 minutes of hyperoxia, 30 minutes after ending hyperoxia	Measurement of retinal vessel diameters before, during and after hyperoxic stimulation.
Retinal perfusion velocities during hyperoxia	Before hyperoxia, after 15 minutes of hyperoxia, 30 minutes after ending hyperoxia	Measurement of retinal perfusion velocities before, during and after hyperoxic stimulation.
Retinal oximetry during hyperoxia	Before hyperoxia, after 15 minutes of hyperoxia, 30 minutes after ending hyperoxia	Measurement of retinal oximetry status before, during and after hyperoxic stimulation.
Retinal vessel diameters during hyperglycemia	Before glucose ingestion, every 30 minutes for 3 hours following oral glucose load	Measurement of retinal vessel diameters before, during and after hyperglycemic stimulation.
Retinal perfusion during hyperglycemia	Before glucose ingestion, every 30 minutes for 3 hours following oral glucose load	Measurement of retinal perfusion velocities before, during and after hyperglycemic stimulation.
Retinal oximetry during hyperglycemia	Before glucose ingestion, every 30 minutes for 3 hours following oral glucose load	Measurement of retinal oximetry status before, during and after hyperglycemic stimulation.

Trial Locations

Locations (1)

Department of Ophthalmology, Glostrup University Hospital; 🇩🇰 Glostrup, Denmark