Diabetic RetinopathyDIRMANCT04610749
Diabetic Retinopathy as a Marker of Cognitive Dysfunction and Depression
An observational study of Diabetic Retinopathy and Depression, run by Region of Southern Denmark at 1 site in Denmark.
Trial summary
In recent years damage to the nerve fibers in the retina has been experienced as an early sign of complications resulting from type 2 diabetes. In addition, it has been presented that people with type 2 diabetes are at increased risk of developing brain diseases, such as mild memory impairment and Alzheimer's disease… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Diabetic Retinopathy, Depression, Cognitive Impairment
- How many people
- 148 participants
- Where
- 1 siteDenmark
- Study dates
- 25 Nov 2020to 25 Feb 2022
- Phase
- Observational
- 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 65 years and older
- All sexes
- Older adult
Study population: Patients with type 2 diabetes
Who may be able to join
- Type 2 diabetes
- 65 years and older
- Diabetes duration of at least 5 years
- None to severe non-proliferative DR (NPDR), as determined by the evaluating ophthalmologists using fundus examination by slit-lamp biomicroscopy or fundus imaging.
- Able to provide informed consent
Who cannot join
- Previous history of stroke or neurodegenerative diseases.
- Proliferative DR (PDR), Diabetic Macular Edema (DME) or other eye disorders affecting vision besides these complications of DR.
- Previous laser photocoagulation.
- Other diseases which may induce retinal neurodegeneration (e.g. glaucoma).
- Subjects with a refractive error ≥ ± 6 D.
- Media opacities that preclude retinal imaging.
- Severe systemic illness or personal circumstances that would not make it possible for the patients to fulfil study protocols.
Trial locations and contacts
1 site in 1 country.
About this study
In recent years damage to the nerve fibers in the retina has been experienced as an early sign of complications resulting from type 2 diabetes.
In addition, it has been presented that people with type 2 diabetes are at increased risk of developing brain diseases, such as mild memory impairment and Alzheimer's disease, as well as mental illness in the form of depression.
Read more
The eye corresponds to be a protruding part of the brain which means the brain and the eye share common features.
Currently it is time and cost consuming to asses changes in the brain, but recent research has shown that patient friendly eye examinations can detect nerve loss brain diseases.
Recent studies have shown that depression can also have a physiological component, which can be measured by changes in structures in the retina of the eye.
In this research project, we will conduct a clinical study, to assess whether there is an association between changes in the retina of the eye (e.g. vascular structure, retinal thickness and oxygen saturation) and mild memory impairment and depression respectively in people with type 2 diabetes.
The clinical study will help to clarify the possibility of including patient-friendly eye examinations in the assessment of minimal memory impairment and depression in patients with type 2 diabetes.
200 people with type 2 diabetes will be invited to participate in a clinical cross-sectional study. The Funen Diabetes Database will be used as recruitment tool. Participants will undergo a thorough eye examination as well as neuropsychological examinations for signs of mild memory impairment. They will also complete questionnaires regarding depressive symptoms.
Overall, the research project will help to create awareness in this area among both healthcare professionals and patients. Early risk detection could mean better diabetes care and fewer complications, which will have a major impact on quality of life and contribute to socio-economic gains. Any findings may contribute to the discussion of individualized screening and treatment if some individuals within this group are at increased risk of developing memory impairment or depression.
Read the detailed description
A cross sectional study will be performed to determine correlation between retinal endpoints in persons with type 2 diabetes and cognitive impairment. 200 patients with type 2 diabetes without diabetic retinopathy and non to severe diabetic retinopathy.
Primary objective:
To determine whether structural and/or metabolic retinal markers are able to differentiate people with minimal cognitive impairment (MCI) within persons with type 2 diabetes (T2D).
Secondary objective
- To assess whether retinal metabolism measured by oximetry can identify individuals with MCI among people with T2D.
- To assess whether retinal metabolism measured by oximetry can identify individuals with depressive symptoms among people with T2D.
- To determine whether retinal structural markers can identify people with depressive symptoms among people with T2D.
- Medical subject headings
- Diabetic Retinopathy, Depression, Cognitive Dysfunction
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal metabolism
Measured by retinal oximetry
Measured: 1 day
Secondary outcomes (4)
Retinal neurodegeneration
Measured by Spectral Domain Optical Coherence Tomography
Measured: 1 day
Central Retinal vascular abnormalities
Measured by fundus photography and analyzed with semi automated software
Measured: 1 day
Retinal vascular abnormalities
Measured by Optical Coherence Tomography Angiography
Measured: 1 day
Depressive symptoms
Measured by Geriatric depression scale GDS-15 and Measured by Inventory of depressive symptomatology (Self-report)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start25 Nov 2020
- Primary completion25 Feb 2022
- Study completion25 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic RetinopathyStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frederik Nørregaard Pedersen, Region of Southern Denmark
- Investigators
- Frederik N Pedersen, M.D, Principal investigator, Department of Ophthalmology, OUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04610749
- Sponsor's protocol ID
- S-20200050
- Acronym
- DIRMA
- Status last verified
- Apr 2022
- First submitted
- 22 Oct 2020
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: •Undecided: It is not yet known if there will be a plan to make IPD available
Publications
Pedersen FN, Stokholm L, Lois N, Yang D, Cheung CY, Simo R, Peto T, Pouwer F, Grauslund J. Associations between metabolic and structural retinal parameters and depression in individuals with type 2 diabetes. Int J Retina Vitreous. 2026 Jan 27;12(1):29. doi: 10.1186/s40942-026-00800-x.
PubMed 41593780
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetic Retinopathy as a Marker of Cognitive Dysfunction and Depression
- ClinicalTrials.gov ID
- NCT04610749
- Acronym / sponsor ID
- DIRMA / S-20200050
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Region of Southern DenmarkUniversity, hospital or other
- Study start
- 25 Nov 2020 (actual)
- Primary completion
- 25 Feb 2022 (actual)
- Study completion
- 25 Feb 2022 (actual)
- First posted
- 30 Oct 2020 (actual)
- 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.
In recent years damage to the nerve fibers in the retina has been experienced as an early sign of complications resulting from type 2 diabetes.
In addition, it has been presented that people with type 2 diabetes are at increased risk of developing brain diseases, such as mild memory impairment and Alzheimer's disease, as well as mental illness in the form of depression.
The eye corresponds to be a protruding part of the brain which means the brain and the eye share common features.
Currently it is time and cost consuming to asses changes in the brain, but recent research has shown that patient friendly eye examinations can detect nerve loss brain diseases.
Recent studies have shown that depression can also have a physiological component, which can be measured by changes in structures in the retina of the eye.
In this research project, we will conduct a clinical study, to assess whether there is an association between changes in the retina of the eye (e.g. vascular structure, retinal thickness and oxygen saturation) and mild memory impairment and depression respectively in people with type 2 diabetes.
The clinical study will help to clarify the possibility of including patient-friendly eye examinations in the assessment of minimal memory impairment and depression in patients with type 2 diabetes.
200 people with type 2 diabetes will be invited to participate in a clinical cross-sectional study. The Funen Diabetes Database will be used as recruitment tool. Participants will undergo a thorough eye examination as well as neuropsychological examinations for signs of mild memory impairment. They will also complete questionnaires regarding depressive symptoms.
Overall, the research project will help to create awareness in this area among both healthcare professionals and patients. Early risk detection could mean better diabetes care and fewer complications, which will have a major impact on quality of life and contribute to socio-economic gains. Any findings may contribute to the discussion of individualized screening and treatment if some individuals within this group are at increased risk of developing memory impairment or depression.
Detailed description
A cross sectional study will be performed to determine correlation between retinal endpoints in persons with type 2 diabetes and cognitive impairment. 200 patients with type 2 diabetes without diabetic retinopathy and non to severe diabetic retinopathy.
Primary objective:
To determine whether structural and/or metabolic retinal markers are able to differentiate people with minimal cognitive impairment (MCI) within persons with type 2 diabetes (T2D).
Secondary objective
- To assess whether retinal metabolism measured by oximetry can identify individuals with MCI among people with T2D.
- To assess whether retinal metabolism measured by oximetry can identify individuals with depressive symptoms among people with T2D.
- To determine whether retinal structural markers can identify people with depressive symptoms among people with T2D.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- Patients with type 2 diabetes
Key inclusion criteria (5 listed)
- Type 2 diabetes
- 65 years and older
- Diabetes duration of at least 5 years
- None to severe non-proliferative DR (NPDR), as determined by the evaluating ophthalmologists using fundus examination by slit-lamp biomicroscopy or fundus imaging.
- Able to provide informed consent
Key exclusion criteria (7 listed)
- Previous history of stroke or neurodegenerative diseases.
- Proliferative DR (PDR), Diabetic Macular Edema (DME) or other eye disorders affecting vision besides these complications of DR.
- Previous laser photocoagulation.
- Other diseases which may induce retinal neurodegeneration (e.g. glaucoma).
- Subjects with a refractive error ≥ ± 6 D.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Retinal metabolism
Time frame: 1 day
Measured by retinal oximetry
4 secondary outcomes
Retinal neurodegeneration
Time frame: 1 day
Central Retinal vascular abnormalities
Time frame: 1 day
Retinal vascular abnormalities
Time frame: 1 day
Depressive symptoms
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
- Derived from this study: PubMed 41593780Pedersen FN, Stokholm L, Lois N, Yang D, Cheung CY, Simo R, Peto T, Pouwer F, Grauslund J. Associations between metabolic and structural retinal parameters and depression in individuals with type 2 diabetes. Int J Retina Vitreous. 2026 Jan 27;12(1):29. doi: 10.1186/s40942-026-00800-x.
- Individual participant dataSharing planned: Undecided. •Undecided: It is not yet known if there will be a plan to make IPD available
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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.
Frederik N Pedersen, M.D principal investigator
Department of Ophthalmology, OUH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Retinopathy and Depression, run by Region of Southern Denmark 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 5 inclusion and 7 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: finished, as of the sponsor's last update on 4 Apr 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retinal metabolism (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04610749, which also lists 1 linked publication.
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 4 Apr 2022.