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Active, Not Recruiting

NCT Number: NCT07602348

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Diabetic Retinopathy Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetic Angiopathies Endocrine System Diseases Endothelial Dysfunction Eye Diseases GLP-1 Glucose Metabolism Disorders Metabolic Diseases Microvascular Circulation Nutritional and Metabolic Diseases Retinal Diseases Retinal Vascular Diseases SGLT 2 Inhibitors Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

2nd Department of Ophthalmology, Attikon University Hospital, National and Kapodistrian University of Athens

Athens, Attica, 12462, Greece

About this study

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:

i) 20 participants treated with metformin and GLP-1RAs; ii) 20 participants treated with metformin and SGLT2 inhibitors.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Changes in Retinal Thickness Parameters

    Time frame: Changes from baseline to 12-month follow-up.

    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).

  2. Change in Retinal Microvascular Parameters

    Time frame: Changes from baseline to 12-month follow-up.

    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).

  3. Changes in Endothelial Glycocalyx function

    Time frame: Changes from baseline to 12-month follow-up.

    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.

  4. Change in Arterial Stiffness

    Time frame: Changes from baseline to 12-month follow-up.

    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).

Sponsors and collaborators

Lead sponsor

University of Athens

Other

Registry information

Acronym: ARIADNE

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 22, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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