Measurement of Ocular Blood Flow and Retinal Oxygen Extraction in Diabetic Patients

Обзор

The prevalence of diabetes is increasing, with type 2 diabetes mellitus comprising over 90% of cases. Diabetes mellitus complications, including diabetic retinopathy (DR), impose significant health burdens. GLP-1 receptor agonists (GLP-1RAs) and dual GIP/GLP-1 receptor agonists show promise in improving cardiovascular and kidney outcomes, but their effects on retinal microvasculature and neuroprotection remain unclear. This study investigates the impact of GLP-1RAs (semaglutide, liraglutide) and GIP/GLP-1-dual agonists (tirzepatide) on ocular blood flow and retinal function in DM patients.

Вмешательства

• Устройство • Laser Speckle Flowgraphy (LSFG)
  Laser Speckle Flowgraphy (LSFG)
• Устройство • Optical Coherence Tomography (OCT)
  • Optical Coherence Tomography (OCT)
• Устройство • Optical Coherence Tomography Angiography (OCT-A)
  • Optical Coherence Tomography Angiography (OCT-A)

Первичные конечные точки

• Ocular blood flow (LSFG) [Срок оценки: From enrollment to last study day (=5-11 weeks)]

Вторичные конечные точки (12)

• Retinal vessel diameter [Срок оценки: From enrollment to last study day (=5-11 weeks)]
• Retinal oxygen saturation [Срок оценки: From enrollment to last study day (=5-11 weeks)]
• Retinal oxygen extraction [Срок оценки: From enrollment to last study day (=5-11 weeks)]
• Oxygen and carbon dioxide partial pressure in arterialized blood [Срок оценки: From enrollment to last study day (=5-11 weeks)]
• Central retinal thickness [Срок оценки: From enrollment to last study day (=5-11 weeks)]
• Retinal nerve fiber layer thickness [Срок оценки: From enrollment to last study day (=5-11 weeks)]
• Retinal and choroidal microvasculature [Срок оценки: From enrollment to last study day (=5-11 weeks)]
• Capillary blood glucose level [Срок оценки: From enrollment to last study day (=5-11 weeks)]
• Autonomic and sensomotoric neuropathy measurements [Срок оценки: From enrollment to last study day (=5-11 weeks)]
• Ocular perfusion pressure [Срок оценки: From enrollment to last study day (=5-11 weeks)]
• Intraocular pressure [Срок оценки: From enrollment to last study day (=5-11 weeks)]
• Systemic hemodynamics - Blood pressure [Срок оценки: From enrollment to last study day (=5-11 weeks)]

Критерии участия

Критерии включения

• Men and women aged ≥ 18 years
• Signed informed consent
• Previously diagnosed diabetes mellitus
• Normal ophthalmic findings except diabetic retinopathy, unless the investigator considers an abnormality to be clinically irrelevant
• Planned initiation of therapy with GLP-1 receptor agonist (Semaglutide, Ozempic®; Liraglutide, Victoza®) or GIP/GLP-1 receptor agonist (Tirzepatide, Mounjaro®) by a diabetes specialist

Критерии исключения

• Participation in a clinical trial in the 3 weeks preceding the screening visit
• Symptoms of a clinically relevant illness in the 3 weeks before the first study day
• Presence or history of a severe medical condition, except diabetes, as judged by the clinical investigator
• Abuse of alcoholic beverages
• Blood donation during the previous three weeks
• Presence of any abnormalities preventing reliable measurements in the study eye as judged by the investigator
• Previous laser photocoagulation treatment in the study eye
• Best corrected visual acuity < 0.4 Snellen
• Women of childbearing potential (neither menopausal, nor hysterectomized, nor sterilized) not using effective contraception
• Pregnancy, planned pregnancy or lactation

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Австрия · 1 центр

• Medical University Vienna — Vienna

Идентификаторы

NCT: NCT07536516 · OPHT-25022025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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