Assessment of Retinal-Angio Findings In Patients With Diabetes Type II Treated With Novel Antidiabetic Therapies (ARIADNE)
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Attica
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Athens、Attica、ギリシャ、12462
- 2nd Department of Ophthalmology, Attikon University Hospital, National and Kapodistrian University of Athens
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
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GLP-1RAs
Subjects will take GLP-1RAs
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SGLT2-i
Subjects will take SGLT2-i
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Changes in Ocular Parameters
時間枠：Changes from baseline to 12-month follow-up.
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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.
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Changes from baseline to 12-month follow-up.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Changes in Retinal Thickness Parameters
時間枠：Changes from baseline to 12-month follow-up.
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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).
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Changes from baseline to 12-month follow-up.
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Change in Retinal Microvascular Parameters
時間枠：Changes from baseline to 12-month follow-up.
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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).
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Changes from baseline to 12-month follow-up.
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Changes in Endothelial Glycocalyx function
時間枠：Changes from baseline to 12-month follow-up.
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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.
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Changes from baseline to 12-month follow-up.
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Change in Arterial Stiffness
時間枠：Changes from baseline to 12-month follow-up.
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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).
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Changes from baseline to 12-month follow-up.
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 137-16/02/2024
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