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Assessment of Retinal-Angio Findings In Patients With Diabetes Type II Treated With Novel Antidiabetic Therapies (ARIADNE)

18. mai 2026 oppdatert av: Irini Chatziralli, University of Athens

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.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

40

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Hellas
    • Attica
      • Athens, Attica, Hellas, 12462
        • 2nd Department of Ophthalmology, Attikon University Hospital, National and Kapodistrian University of Athens

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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).

Beskrivelse

Inclusion Criteria:

  1. Individuals aged ≥18 years.
  2. Male and/or female patients with T2DM diagnosed according to the criteria established by the EASD and the ADA.
  3. Patients receiving only metformin as antidiabetic treatment.
  4. Patients who have not previously received SGLT2 inhibitors or GLP-1 receptor agonists.
  5. Patients who are able to provide informed consent for participation in the study.

Exclusion Criteria:

  1. Patients who are pregnant or breastfeeding.
  2. History of multiple severe hypoglycaemic episodes during the past two years.
  3. History of ketoacidosis or metabolic acidosis.
  4. Active intraocular inflammation in either eye, such as infectious conjunctivitis, keratitis, scleritis, endophthalmitis, or autoimmune uveitis.
  5. Patients who have undergone panretinal photocoagulation within the last 6 months.
  6. Patients who have received intravitreal anti-vascular endothelial growth factor (anti-VEGF) therapy or corticosteroids within the last 6 months.
  7. Patients who have undergone cataract surgery or vitrectomy within the last 6 months.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
GLP-1RAs
Subjects will take GLP-1RAs
SGLT2-i
Subjects will take SGLT2-i

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Changes in Ocular Parameters
Tidsramme: 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.
Changes from baseline to 12-month follow-up.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Changes in Retinal Thickness Parameters
Tidsramme: 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).
Changes from baseline to 12-month follow-up.
Change in Retinal Microvascular Parameters
Tidsramme: 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).
Changes from baseline to 12-month follow-up.
Changes in Endothelial Glycocalyx function
Tidsramme: 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.
Changes from baseline to 12-month follow-up.
Change in Arterial Stiffness
Tidsramme: 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).
Changes from baseline to 12-month follow-up.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Athens

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. mars 2024

Primær fullføring (Faktiske)

30. januar 2026

Studiet fullført (Antatt)

31. mai 2026

Datoer for studieregistrering

Først innsendt

24. april 2026

Først innsendt som oppfylte QC-kriteriene

18. mai 2026

Først lagt ut (Faktiske)

22. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

18. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 137-16/02/2024

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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