Dynamic Parameters of Glucose Control in Relation to Biomarkers in Serum and Intraocular Fluid in Patients With Diabetes
July 6, 2023 updated by: Martin Prázný, Charles University, Czech Republic
Dynamic Parameters of Glucose Control in Relation to Biomarkers in Serum and Intraocular Fluid in Diabetic Patients With Ocular Complications
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Estimated)
213
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Martin Prázný, Prof.
- Phone Number: +420737122570
- Email: mpra@lf1.cuni.cz
Study Contact Backup
- Name: Petra Svozílková, Prof.
- Phone Number: +420604801153
- Email: petra.svozilkova@lf1.cuni.cz
Study Locations
-
-
-
Prague, Czechia, 12808
- Recruiting
- General University Hospital in Prague
-
Contact:
- Martin Prázný, Prof.
- Phone Number: +420737122570
- Email: mpra@lf1.cuni.cz
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
Pars plana vitrectomy or cataract surgery.
|
|
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.
|
Pars plana vitrectomy or cataract surgery.
|
|
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.
|
Pars plana vitrectomy or cataract surgery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
miRNA
Time Frame: Year 2025
|
miRNA expression measuer by real-time PCR method in plasma and vitreous samples (units: threshold cycle)
|
Year 2025
|
|
TIR
Time Frame: Year 2025
|
Percentage of time in target ranges
|
Year 2025
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
miRNA expression differences
Time Frame: Year 2025
|
miRNA expression differences analysis between diabetic patients with and without diabetic retinopathy (units: fold change)
|
Year 2025
|
|
Glycemic variability
Time Frame: Year 2025
|
Expressed as the standard deviation
|
Year 2025
|
|
Mean sensor glucose concentration
Time Frame: Year 2025
|
Measured by rtCGM
|
Year 2025
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Martin Prázný, Prof., Charles University and General University Hospital in Prague
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2022
Primary Completion (Estimated)
December 31, 2025
Study Completion (Estimated)
June 1, 2026
Study Registration Dates
First Submitted
February 7, 2023
First Submitted That Met QC Criteria
July 6, 2023
First Posted (Actual)
July 13, 2023
Study Record Updates
Last Update Posted (Actual)
July 13, 2023
Last Update Submitted That Met QC Criteria
July 6, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NU22-01-00077
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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