Diabetes Complications
Conditions
Keywords
biomarkers, retinopathy, miRNA, diabetes mellitus, glucose variability
Brief summary
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.
Detailed description
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.
Interventions
Pars plana vitrectomy or cataract surgery.
Sponsors
Study design
Eligibility
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| miRNA | Year 2025 | miRNA expression measuer by real-time PCR method in plasma and vitreous samples (units: threshold cycle) |
| TIR | Year 2025 | Percentage of time in target ranges |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| miRNA expression differences | Year 2025 | miRNA expression differences analysis between diabetic patients with and without diabetic retinopathy (units: fold change) |
| Glycemic variability | Year 2025 | Expressed as the standard deviation |
| Mean sensor glucose concentration | Year 2025 | Measured by rtCGM |
Countries
Czechia