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| Name | Class |
|---|---|
| Czech Health Research Council | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with DR | Adult patients with T1DM or T2DM with any form of diabetic retinopathy and diabetic macular edema, indicated for ocular surgical procedure as standard of care. Blood samples and samples of intraocular fluids will bee taken during the ocular surgery. |
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| Patients without DR | Adult patients with T1DM or T2DM without any signs of diabetic retinopathy, indicated for ocular surgical procedure from other reasons as standard of care. Blood samples and samples of intraocular fluids will bee taken during the ocular surgery. |
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| Control group | Subjects without diabetes mellitus indicated for ocular surgery from other reasons (cataract, retinal detachment, macular hole, idiopathic epiretinal membrane) as standard of care. Blood samples and samples of intraocular fluids will bee taken during the ocular surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraocular surgery | Procedure | Pars plana vitrectomy or cataract surgery. |
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| Measure | Description | Time Frame |
|---|---|---|
| miRNA | miRNA expression measuer by real-time PCR method in plasma and vitreous samples (units: threshold cycle) | Year 2025 |
| TIR | Percentage of time in target ranges | Year 2025 |
| Measure | Description | Time Frame |
|---|---|---|
| miRNA expression differences | miRNA expression differences analysis between diabetic patients with and without diabetic retinopathy (units: fold change) | Year 2025 |
| Glycemic variability | Expressed as the standard deviation |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with T1DM or T2DM treated with insulin with or without any form of diabetic retinopathy and the matched controls, who are indicated to ocular surgery procedure as standard of care.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Martin Prázný, Prof. | Contact | +420737122570 | mpra@lf1.cuni.cz | |
| Petra Svozílková, Prof. | Contact | +420604801153 | petra.svozilkova@lf1.cuni.cz |
| Name | Affiliation | Role |
|---|---|---|
| Martin Prázný, Prof. | Charles University and General University Hospital in Prague | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General University Hospital in Prague | Recruiting | Prague | 12808 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18299315 | Background | Ceriello A, Esposito K, Piconi L, Ihnat MA, Thorpe JE, Testa R, Boemi M, Giugliano D. Oscillating glucose is more deleterious to endothelial function and oxidative stress than mean glucose in normal and type 2 diabetic patients. Diabetes. 2008 May;57(5):1349-54. doi: 10.2337/db08-0063. Epub 2008 Feb 25. | |
| 24401008 | Background |
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| ID | Term |
|---|---|
| D048909 | Diabetes Complications |
| D012164 | Retinal Diseases |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D004700 | Endocrine System Diseases |
| D005128 | Eye Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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We determined the biomarkers that are present in blood and/or intraocular fluid of patients with ocular complications. MicroRNA (miRNA) and inflammatory chemokines/cytokines (VEGF, IL-6, IL-8, TNF-α, IL-1β and MCP-1) are the candidates. miRNA are small non-coding RNAs, which regulate gene expression at the post-transcriptional level.
| Year 2025 |
| Mean sensor glucose concentration | Measured by rtCGM | Year 2025 |
| Soupal J, Skrha J Jr, Fajmon M, Horova E, Mraz M, Skrha J, Prazny M. Glycemic variability is higher in type 1 diabetes patients with microvascular complications irrespective of glycemic control. Diabetes Technol Ther. 2014 Apr;16(4):198-203. doi: 10.1089/dia.2013.0205. Epub 2014 Jan 8. |
| 18571393 | Background | Zoppini G, Verlato G, Targher G, Casati S, Gusson E, Biasi V, Perrone F, Bonora E, Muggeo M. Is fasting glucose variability a risk factor for retinopathy in people with type 2 diabetes? Nutr Metab Cardiovasc Dis. 2009 Jun;19(5):334-9. doi: 10.1016/j.numecd.2008.02.007. Epub 2008 Jun 20. |
| 21035886 | Background | Takao T, Ide T, Yanagisawa H, Kikuchi M, Kawazu S, Matsuyama Y. The effects of fasting plasma glucose variability and time-dependent glycemic control on the long-term risk of retinopathy in type 2 diabetic patients. Diabetes Res Clin Pract. 2011 Feb;91(2):e40-2. doi: 10.1016/j.diabres.2010.10.009. Epub 2010 Oct 29. |
| 32113513 | Background | Vujosevic S, Aldington SJ, Silva P, Hernandez C, Scanlon P, Peto T, Simo R. Screening for diabetic retinopathy: new perspectives and challenges. Lancet Diabetes Endocrinol. 2020 Apr;8(4):337-347. doi: 10.1016/S2213-8587(19)30411-5. Epub 2020 Feb 27. |
| 14970398 | Background | Meister G, Landthaler M, Dorsett Y, Tuschl T. Sequence-specific inhibition of microRNA- and siRNA-induced RNA silencing. RNA. 2004 Mar;10(3):544-50. doi: 10.1261/rna.5235104. |
| 31290435 | Background | Martinez B, Peplow PV. MicroRNAs as biomarkers of diabetic retinopathy and disease progression. Neural Regen Res. 2019 Nov;14(11):1858-1869. doi: 10.4103/1673-5374.259602. |
| 29084332 | Background | Boss JD, Singh PK, Pandya HK, Tosi J, Kim C, Tewari A, Juzych MS, Abrams GW, Kumar A. Assessment of Neurotrophins and Inflammatory Mediators in Vitreous of Patients With Diabetic Retinopathy. Invest Ophthalmol Vis Sci. 2017 Oct 1;58(12):5594-5603. doi: 10.1167/iovs.17-21973. |
| 28680705 | Background | Wu H, Hwang DK, Song X, Tao Y. Association between Aqueous Cytokines and Diabetic Retinopathy Stage. J Ophthalmol. 2017;2017:9402198. doi: 10.1155/2017/9402198. Epub 2017 Jun 7. |
| 30410092 | Background | Mastropasqua R, D'Aloisio R, Di Nicola M, Di Martino G, Lamolinara A, Di Antonio L, Tognetto D, Toto L. Relationship between aqueous humor cytokine level changes and retinal vascular changes after intravitreal aflibercept for diabetic macular edema. Sci Rep. 2018 Nov 8;8(1):16548. doi: 10.1038/s41598-018-35036-9. |
| D009750 |
| Nutritional and Metabolic Diseases |