Dynamic Parameters of Glucose Control in Relation to Biomarkers in Serum and Intraocular Fluid in Patients With Diabetes

Diabetes Complications Clinical Trial

Official title:

Dynamic Parameters of Glucose Control in Relation to Biomarkers in Serum and Intraocular Fluid in Diabetic Patients With Ocular Complications

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05944640
• Other study ID #: NU22-01-00077
• Status: Recruiting
• Start date: April 1, 2022
• Est. completion date: June 1, 2026

Study information

• Verified date: July 2023
• Source: Charles University, Czech Republic
• Contact: Martin Prázný, Prof.
• Phone: +420737122570
• Email: mpra[@]lf1.cuni.cz
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 213
• Est. completion date: June 1, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Diabetes Complications

Intervention

Procedure:
• Intraocular surgery
Pars plana vitrectomy or cataract surgery.

Locations

Country	Name	City	State
Czechia	General University Hospital in Prague	Prague

Sponsors (2)

Lead Sponsor	Collaborator
Charles University, Czech Republic	Czech Health Research Council

Country where clinical trial is conducted

Czechia, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	miRNA	miRNA expression measuer by real-time PCR method in plasma and vitreous samples (units: threshold cycle)	Year 2025
Primary	TIR	Percentage of time in target ranges	Year 2025
Secondary	miRNA expression differences	miRNA expression differences analysis between diabetic patients with and without diabetic retinopathy (units: fold change)	Year 2025
Secondary	Glycemic variability	Expressed as the standard deviation	Year 2025
Secondary	Mean sensor glucose concentration	Measured by rtCGM	Year 2025