Measurement of Ocular Blood Flow and Retinal Oxygen Extraction in Diabetic Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Ocular blood flow (LSFG)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Diabetes mellitus GLP1-RA
Measurements of the Ocular Blood Flow and Retinal Oxygen Extraction are performed.
干预措施: • Laser Speckle Flowgraphy (LSFG) (Device)
Diabetes mellitus GLP1-RA
Measurements of the Ocular Blood Flow and Retinal Oxygen Extraction are performed.
干预措施: • Optical Coherence Tomography (OCT) (Device)
Diabetes mellitus GLP1-RA
Measurements of the Ocular Blood Flow and Retinal Oxygen Extraction are performed.
干预措施: • Optical Coherence Tomography Angiography (OCT-A) (Device)
结局指标
主要结局
Ocular blood flow (LSFG)
时间窗: From enrollment to last study day (=5-11 weeks)
Ocular Blood Flow measured by Laser Speckle Flowgraphy (LSFG) in arbitrary units
次要结局
- Retinal vessel diameter(From enrollment to last study day (=5-11 weeks))
- Retinal oxygen saturation(From enrollment to last study day (=5-11 weeks))
- Capillary blood glucose level(From enrollment to last study day (=5-11 weeks))
- Retinal oxygen extraction(From enrollment to last study day (=5-11 weeks))
- Oxygen and carbon dioxide partial pressure in arterialized blood(From enrollment to last study day (=5-11 weeks))
- Central retinal thickness(From enrollment to last study day (=5-11 weeks))
- Retinal nerve fiber layer thickness(From enrollment to last study day (=5-11 weeks))
- Retinal and choroidal microvasculature(From enrollment to last study day (=5-11 weeks))
- Autonomic and sensomotoric neuropathy measurements(From enrollment to last study day (=5-11 weeks))
- Ocular perfusion pressure(From enrollment to last study day (=5-11 weeks))
- Intraocular pressure(From enrollment to last study day (=5-11 weeks))
- Systemic hemodynamics - Blood pressure(From enrollment to last study day (=5-11 weeks))
- Schirmer I Test(From enrollment to last study day (=5-11 weeks))
- Finger sweat sampling(From enrollment to last study day (=5-11 weeks))
- Systemic hemodynamics - Heart rate(From enrollment to last study day (=5-11 weeks))
- Systemic hemodynamics - Oxygen saturation(From enrollment to last study day (=5-11 weeks))
研究者
Doreen Schmidl
Assoc. Prof. Priv. Doz. Dr., PhD
Medical University of Vienna