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

NCT01721811 | Unknown

• 1 other identifier: Klefter2
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Individuals; Patients With Diabetes.

Outcome Measures

Primary Outcomes (6)

• Retinal vessel diameters during hyperoxia

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

  Before hyperoxia, after 15 minutes of hyperoxia, 30 minutes after ending hyperoxia

• Retinal perfusion velocities during hyperoxia

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

  Before hyperoxia, after 15 minutes of hyperoxia, 30 minutes after ending hyperoxia

• Retinal oximetry during hyperoxia

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

  Before hyperoxia, after 15 minutes of hyperoxia, 30 minutes after ending hyperoxia

• Retinal vessel diameters during hyperglycemia

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

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

• Retinal perfusion during hyperglycemia

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

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

• Retinal oximetry during hyperglycemia

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

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

Study Arms (2)

Healthy

EXPERIMENTAL

Healthy study participanats

Other: Hyperoxia; Other: Glucose

Diabetes

EXPERIMENTAL

Patients with diabetes

Other: Hyperoxia; Other: Glucose

Interventions

Hyperoxia OTHER

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

Diabetes; Healthy

Glucose OTHER

Also known as: Standardised oral glucose load.

Diabetes; Healthy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Any systemic or ocular disease.
• Patients with diabetes
• Diabetes mellitus
• No intraocular disease other than conditions attributable to diabetes.
• Intraocular disease other than conditions attributable to diabetes.
• Systemic conditions which might contraindicate hyperoxic stimulation.

Sponsors & Collaborators

• Glostrup University Hospital, Copenhagen: lead

Study Sites (1)

Department of Ophthalmology, Glostrup University Hospital

Glostrup Municipality, 2600, Denmark

RECRUITING

MeSH Terms

Interventions

Glucose

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Oliver Klefter, MD

  Glostrup UH

  PRINCIPAL INVESTIGATOR

• Michael Larsen, Professor, DMSci

  Glostrup UH

  STUDY DIRECTOR

Central Study Contacts

Oliver Klefter, MD

CONTACT

+45 38 63 48 18

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 31, 2012
• First Posted: November 6, 2012
• Study Start: October 1, 2012
• Primary Completion: December 1, 2015
• Last Updated: March 11, 2015

Record last verified: 2015-03

Locations

DK (1)