Healthy IndividualsNCT01721811
Retinal Function in Relation to Transient or Chronic Challenges to Retinal Metabolism
A study testing Hyperoxia and Glucose in people with Healthy Individuals and Patients With Diabetes., run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Individuals, Patients With Diabetes.
- What is being tested?
- Hyperoxia and Glucose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2012to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers.
- No known systemic or ocular disease.
- Diabetes mellitus
- No intraocular disease other than conditions attributable to diabetes.
Who cannot join
- Any systemic or ocular disease.
- Patients with diabetes
- Intraocular disease other than conditions attributable to diabetes.
- Systemic conditions which might contraindicate hyperoxic stimulation.
Trial locations and contacts
1 site in 1 country.
Oliver Klefter, MD contact
Denmark1 site, 1 recruiting
- Recruiting
Department of Ophthalmology, Glostrup University Hospital
Glostrup Municipality, 2600
Oliver Klefter, MD, +45 38 63 48 18
Michael Larsen, Professor, DMSci
About this study
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.
- Being tested
- Hyperoxia, Glucose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HyperoxiaOther
Also called Hyperoxia is achieved by short-term pure oxygen breathing.
GlucoseOther
Also called Standardised oral glucose load.
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Experimental | Healthy study participanats Receives: Other: Hyperoxia; Other: Glucose |
| Diabetes | Experimental | Patients with diabetes Receives: Other: Hyperoxia; Other: Glucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal vessel diameters during hyperoxia
Measurement of retinal vessel diameters before, during and after hyperoxic stimulation.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Before glucose ingestion, every 30 minutes for 3 hours following oral glucose load
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy IndividualsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oliver Niels Klefter, Glostrup University Hospital, Copenhagen
- Investigators
- Oliver Klefter, MD, Principal investigator, Glostrup UHMichael Larsen, Professor, DMSci, Study director, Glostrup UH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01721811
- Sponsor's protocol ID
- Klefter2
- Status last verified
- Mar 2015
- First submitted
- 31 Oct 2012
- Last updated
- 11 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retinal Function in Relation to Transient or Chronic Challenges to Retinal Metabolism
- ClinicalTrials.gov ID
- NCT01721811
- Acronym / sponsor ID
- Klefter2
- Conditions
- Healthy Individuals, Patients With Diabetes.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Dec 2015 (estimated)
- First posted
- 6 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy | Experimental | Other: Hyperoxia, Other: GlucoseHealthy study participanats |
| Diabetes | Experimental | Other: Hyperoxia, Other: GlucosePatients with diabetes |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy volunteers.
- No known systemic or ocular disease.
- Diabetes mellitus
- No intraocular disease other than conditions attributable to diabetes.
Key exclusion criteria (4 listed)
- Any systemic or ocular disease.
- Patients with diabetes
- Intraocular disease other than conditions attributable to diabetes.
- Systemic conditions which might contraindicate hyperoxic stimulation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HyperoxiaAlso: Hyperoxia is achieved by short-term pure oxygen breathing. | Other | Diabetes, Healthy |
| GlucoseAlso: Standardised oral glucose load. | Other | Diabetes, Healthy |
Primary outcome
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.
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.
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oliver Klefter, MD contact
Oliver Klefter, MD principal investigator
Glostrup UH
Michael Larsen, Professor, DMSci study director
Glostrup UH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperoxia and Glucose in people with Healthy Individuals and Patients With Diabetes., run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Oliver Klefter, MD (+45 38 63 48 18), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retinal vessel diameters during hyperoxia (time frame: Before hyperoxia, after 15 minutes of hyperoxia, 30 minutes after ending hyperoxia). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2015.