Diabetic RetinopathyARIADNENCT07602348
Assessment of Retinal-Angio Findings In Patients With Diabetes Type II Treated With Novel Antidiabetic Therapies
An observational study of Diabetic Retinopathy and GLP-1, run by University of Athens at 1 site in Greece.
Trial summary
ARIADNE is a prospective observational cohort study of patients with type 2 diabetes mellitus (T2DM) treated with daily metformin and scheduled to initiate treatment with newer antidiabetic agents, such as sodium-glucose cotransporter 2 inhibitors (SGLT2 inhibitors) and glucagon-like peptide-1 receptor agonists… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy, GLP-1, SGLT 2 Inhibitors
- How many people
- 40 participants
- Where
- 1 siteGreece
- Study dates
- 1 Mar 2024to 31 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals with type 2 diabetes mellitus (T2DM), diagnosed according to the criteria established by the EASD and the ADA, with and without diabetic retinopathy, who are receiving metformin therapy. Participants will receive, in addition to metformin, either GLP-1 receptor agonists (GLP-1RAs) or sodium-glucose cotransporter 2 inhibitors (SGLT2 inhibitors).
Who may be able to join
- Individuals aged ≥18 years.
- Male and/or female patients with T2DM diagnosed according to the criteria established by the EASD and the ADA.
- Patients receiving only metformin as antidiabetic treatment.
- Patients who have not previously received SGLT2 inhibitors or GLP-1 receptor agonists.
- Patients who are able to provide informed consent for participation in the study.
Who cannot join
- Patients who are pregnant or breastfeeding.
- History of multiple severe hypoglycaemic episodes during the past two years.
- History of ketoacidosis or metabolic acidosis.
- Active intraocular inflammation in either eye, such as infectious conjunctivitis, keratitis, scleritis, endophthalmitis, or autoimmune uveitis.
- Patients who have undergone panretinal photocoagulation within the last 6 months.
- Patients who have received intravitreal anti-vascular endothelial growth factor (anti-VEGF) therapy or corticosteroids within the last 6 months.
- Patients who have undergone cataract surgery or vitrectomy within the last 6 months.
Trial locations and contacts
1 site in 1 country.
Greece1 site
2nd Department of Ophthalmology, Attikon University Hospital, National and Kapodistrian University of Athens
Athens, Attica, 12462
About this study
Official title: Assessment of Retinal-Angio Findings in Patients With Diabetes Type II Treated With Novel Antidiabetic Therapies
ARIADNE is a prospective observational cohort study of patients with type 2 diabetes mellitus (T2DM) treated with daily metformin and scheduled to initiate treatment with newer antidiabetic agents, such as sodium-glucose cotransporter 2 inhibitors (SGLT2 inhibitors) and glucagon-like peptide-1 receptor agonists (GLP-1RAs). These newer antidiabetic agents have demonstrated significant benefits in improving glycaemic control; however, some studies suggest that their rapid glucose-lowering effects may be associated with transient worsening or progression of retinal complications.
The purpose of this study is to evaluate the efficacy and safety of newer antidiabetic agents on retinal vasculature and visual acuity, and to investigate how these changes are associated with alterations in markers of peripheral endothelial and cardiovascular function.
Read the detailed description
The investigators will study individuals with type 2 diabetes mellitus (T2DM), diagnosed according to the criteria established by the European Association for the Study of Diabetes (EASD) and the American Diabetes Association (ADA), with and without diabetic retinopathy, who are receiving metformin therapy. Participants will receive, in addition to metformin, either glucagon-like peptide-1 receptor agonists (GLP-1RAs) or sodium-glucose cotransporter 2 inhibitors (SGLT2 inhibitors).
At treatment initiation (t0) and 12 months after initiation (t1), blood samples, ocular function, peripheral endothelial function, and cardiovascular function will be evaluated.
This study will include 40 participants:
- 20 participants treated with metformin and GLP-1RAs; ii) 20 participants treated with metformin and SGLT2 inhibitors.
- Conditions
- Diabetic Retinopathy, GLP-1, SGLT 2 Inhibitors, Endothelial Dysfunction, Microvascular Circulation, Retinal Vascular Diseases
- Keywords
- diabetic retinopathy, Retinal Vascular Diseases, GLP-1, SGLT 2 inhibitors, Microvascular Circulation, type 2 Diabetes Mellitus
- Medical subject headings
- Diabetic Retinopathy, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| GLP-1RAs | Subjects will take GLP-1RAs | |
| SGLT2-i | Subjects will take SGLT2-i |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Ocular Parameters
Change in Best-Corrected Visual Acuity (BCVA): Assessment of changes in best-corrected visual acuity (BCVA) using standardized Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts.
Measured: Changes from baseline to 12-month follow-up.
Secondary outcomes (4)
Changes in Retinal Thickness Parameters
Change in Retinal Thickness Parameters Assessed by Optical Coherence Tomography (OCT): Assessment of changes from baseline in central subfield thickness (CST), parafoveal retinal thickness, and perifoveal retinal thickness using spectral-domain optical coherence tomography (SD-OCT), reported in micrometers (µm).
Measured: Changes from baseline to 12-month follow-up.
Change in Retinal Microvascular Parameters
Change in Retinal Microvascular Parameters Assessed by Optical Coherence Tomography Angiography (OCT-A): Evaluation of changes from baseline in retinal vessel density and retinal capillary perfusion using optical coherence tomography angiography (OCT-A), reported as percentage (%), and foveal avascular zone (FAZ) area, reported in square millimeters (mm²).
Measured: Changes from baseline to 12-month follow-up.
Changes in Endothelial Glycocalyx function
Change in Endothelial Glycocalyx Thickness Assessed by Perfused Boundary Region (PBR 5-25): Evaluation of changes from baseline in endothelial glycocalyx thickness using perfused boundary region (PBR 5-25) measurements obtained by sublingual microvascular imaging, reported in micrometers (µm). Increased PBR values will be assessed as markers of endothelial dysfunction and microvascular impairment.
Measured: Changes from baseline to 12-month follow-up.
Change in Arterial Stiffness
Change in Carotid-Femoral Pulse Wave Velocity (cf-PWV): Assessment of changes from baseline in arterial stiffness using carotid-femoral pulse wave velocity (cf-PWV), reported in meters per second (m/s).
Measured: Changes from baseline to 12-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start1 Mar 2024
- Primary completion30 Jan 2026
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irini Chatziralli, University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07602348
- Sponsor's protocol ID
- 137-16/02/2024
- Acronym
- ARIADNE
- Status last verified
- May 2026
- First submitted
- 24 Apr 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Retinal-Angio Findings in Patients With Diabetes Type II Treated With Novel Antidiabetic Therapies
- ClinicalTrials.gov ID
- NCT07602348
- Acronym / sponsor ID
- ARIADNE / 137-16/02/2024
- Conditions
- Diabetic Retinopathy, GLP-1, SGLT 2 Inhibitors, Endothelial Dysfunction, Microvascular Circulation, Retinal Vascular Diseases
- Keywords
- diabetic retinopathy, Retinal Vascular Diseases, GLP-1, SGLT 2 inhibitors, Microvascular Circulation, type 2 Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 22 May 2026 (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.
ARIADNE is a prospective observational cohort study of patients with type 2 diabetes mellitus (T2DM) treated with daily metformin and scheduled to initiate treatment with newer antidiabetic agents, such as sodium-glucose cotransporter 2 inhibitors (SGLT2 inhibitors) and glucagon-like peptide-1 receptor agonists (GLP-1RAs). These newer antidiabetic agents have demonstrated significant benefits in improving glycaemic control; however, some studies suggest that their rapid glucose-lowering effects may be associated with transient worsening or progression of retinal complications.
The purpose of this study is to evaluate the efficacy and safety of newer antidiabetic agents on retinal vasculature and visual acuity, and to investigate how these changes are associated with alterations in markers of peripheral endothelial and cardiovascular function.
Detailed description
The investigators will study individuals with type 2 diabetes mellitus (T2DM), diagnosed according to the criteria established by the European Association for the Study of Diabetes (EASD) and the American Diabetes Association (ADA), with and without diabetic retinopathy, who are receiving metformin therapy. Participants will receive, in addition to metformin, either glucagon-like peptide-1 receptor agonists (GLP-1RAs) or sodium-glucose cotransporter 2 inhibitors (SGLT2 inhibitors).
At treatment initiation (t0) and 12 months after initiation (t1), blood samples, ocular function, peripheral endothelial function, and cardiovascular function will be evaluated.
This study will include 40 participants:
- 20 participants treated with metformin and GLP-1RAs; ii) 20 participants treated with metformin and SGLT2 inhibitors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GLP-1RAs | – | –Subjects will take GLP-1RAs |
| SGLT2-i | – | –Subjects will take SGLT2-i |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with type 2 diabetes mellitus (T2DM), diagnosed according to the criteria established by the EASD and the ADA, with and without diabetic retinopathy, who are receiving metformin therapy. Participants will receive, in addition to metformin, either GLP-1 receptor agonists (GLP-1RAs) or sodium-glucose cotransporter 2 inhibitors (SGLT2 inhibitors).
Key inclusion criteria (5 listed)
- Individuals aged ≥18 years.
- Male and/or female patients with T2DM diagnosed according to the criteria established by the EASD and the ADA.
- Patients receiving only metformin as antidiabetic treatment.
- Patients who have not previously received SGLT2 inhibitors or GLP-1 receptor agonists.
- Patients who are able to provide informed consent for participation in the study.
Key exclusion criteria (7 listed)
- Patients who are pregnant or breastfeeding.
- History of multiple severe hypoglycaemic episodes during the past two years.
- History of ketoacidosis or metabolic acidosis.
- Active intraocular inflammation in either eye, such as infectious conjunctivitis, keratitis, scleritis, endophthalmitis, or autoimmune uveitis.
- Patients who have undergone panretinal photocoagulation within the last 6 months.
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
Changes in Ocular Parameters
Time frame: Changes from baseline to 12-month follow-up.
Change in Best-Corrected Visual Acuity (BCVA): Assessment of changes in best-corrected visual acuity (BCVA) using standardized Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts.
4 secondary outcomes
Changes in Retinal Thickness Parameters
Time frame: Changes from baseline to 12-month follow-up.
Change in Retinal Microvascular Parameters
Time frame: Changes from baseline to 12-month follow-up.
Changes in Endothelial Glycocalyx function
Time frame: Changes from baseline to 12-month follow-up.
Change in Arterial Stiffness
Time frame: Changes from baseline to 12-month follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 GLP-1, run by University of Athens at 1 site in Greece.
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: under way, not looking for participants, as of the sponsor's last update on 22 May 2026. 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 Greece. 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?
This study is still under way. Results are not available in the source record yet.
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?
Changes in Ocular Parameters (time frame: Changes from baseline to 12-month follow-up.). 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 22 May 2026.