Skip to content

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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05944640
Enrollment
213
Registered
2023-07-13
Start date
2022-04-01
Completion date
2026-06-01
Last updated
2023-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Complications

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

PROCEDUREIntraocular surgery

Pars plana vitrectomy or cataract surgery.

Sponsors

Czech Health Research Council
CollaboratorUNKNOWN
Charles University, Czech Republic
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
miRNAYear 2025miRNA expression measuer by real-time PCR method in plasma and vitreous samples (units: threshold cycle)
TIRYear 2025Percentage of time in target ranges

Secondary

MeasureTime frameDescription
miRNA expression differencesYear 2025miRNA expression differences analysis between diabetic patients with and without diabetic retinopathy (units: fold change)
Glycemic variabilityYear 2025Expressed as the standard deviation
Mean sensor glucose concentrationYear 2025Measured by rtCGM

Countries

Czechia

Contacts

Primary ContactMartin Prázný, Prof.
mpra@lf1.cuni.cz+420737122570
Backup ContactPetra Svozílková, Prof.
petra.svozilkova@lf1.cuni.cz+420604801153

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026