NCT07602348

Brief 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 (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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
0mo left

Started Mar 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Mar 2024May 2026

Study Start

First participant enrolled

March 1, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2026

Completed
28 days until next milestone

First Posted

Study publicly available on registry

May 22, 2026

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Expected
Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

1.9 years

First QC Date

April 24, 2026

Last Update Submit

May 18, 2026

Conditions

Diabetic RetinopathyGLP-1SGLT 2 InhibitorsEndothelial DysfunctionMicrovascular CirculationRetinal Vascular Diseases

Keywords

diabetic retinopathyRetinal Vascular DiseasesGLP-1SGLT 2 inhibitorsMicrovascular Circulationtype 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • 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.

    Changes from baseline to 12-month follow-up.

Secondary Outcomes (4)

  • Changes in Retinal Thickness Parameters

    Changes from baseline to 12-month follow-up.

  • Change in Retinal Microvascular Parameters

    Changes from baseline to 12-month follow-up.

  • Changes in Endothelial Glycocalyx function

    Changes from baseline to 12-month follow-up.

  • Change in Arterial Stiffness

    Changes from baseline to 12-month follow-up.

Study Arms (2)

GLP-1RAs

Subjects will take GLP-1RAs

SGLT2-i

Subjects will take SGLT2-i

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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).

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Athens, Attica, 12462, Greece

Location

MeSH Terms

Conditions

Diabetic RetinopathyDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Ophthalmology

Study Record Dates

First Submitted

April 24, 2026

First Posted

May 22, 2026

Study Start

March 1, 2024

Primary Completion

January 30, 2026

Study Completion (Estimated)

May 31, 2026

Last Updated

May 22, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)