Dynamic Parameters of Glucose Control in Relation to Biomarkers in Serum and Intraocular Fluid in Diabetic Patients With Ocular Complications
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 213
- 试验地点
- 1
- 主要终点
- miRNA
研究概览
简要总结
Our project investigates the new characteristics of diabetic retinopathy using liquid eye biopsy in combination with novel parameters of glucose control obtained with continuous glucose monitoring. This approach will bring new knowledge and implications for future therapies.
详细描述
Diabetic retinopathy is one of the most common causes of blindness in developed countries. The short-term glucose fluctuations have been suggested as a factor contributing to the risk of diabetic complications including ocular complications. We hypothesize that modulatory and other biological abilities of miRNAs and inflammatory chemokines/cytokines have a significant impact on the development and the progression of diabetic retinopathy. Our main goal is to identify the biomarkers that will in time be used for new screening, diagnostic, and treatment strategies for patients with diabetic retinopathy, bring a better prevention and early treatment to them and thus improve their quality of life while saving the cost associated with advanced forms of retinopathy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •type 1 or type 2 diabetes
- •≥ 18 years old
- •treatment with insulin for at least 5 years prior baseline
- •any form of diabetic retinopathy and macular edema
- •HbA1c < 10%
- •written informed consent prior to starting study related activity
排除标准
- •any active intraocular or periocular infectious or non-infectious inflammation in study eye
- •uncontrolled glaucoma
- •history of intraocular inflammation or trauma in study eye
- •intravitreal anti-VEGF therapy in study eye during a 3-month perido prior to baseline
- •use of corticosteroid intravitreal implant in study eye at any time
结局指标
主要结局
miRNA
时间窗: Year 2025
miRNA expression measuer by real-time PCR method in plasma and vitreous samples (units: threshold cycle)
TIR
时间窗: Year 2025
Percentage of time in target ranges
次要结局
- Glycemic variability(Year 2025)
- Mean sensor glucose concentration(Year 2025)
- miRNA expression differences(Year 2025)
研究者
Martin Prázný
Prof.
Charles University, Czech Republic