Dynamic Parameters of Glucose Control in Relation to Biomarkers in Serum and Intraocular Fluid in Patients With Diabetes
1 other identifier
observational
213
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2022
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2022
CompletedFirst Submitted
Initial submission to the registry
February 7, 2023
CompletedFirst Posted
Study publicly available on registry
July 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
CompletedJuly 13, 2023
July 1, 2023
3.8 years
February 7, 2023
July 6, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (3)
miRNA expression differences
Year 2025
Glycemic variability
Year 2025
Mean sensor glucose concentration
Year 2025
Study Arms (3)
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.
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.
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.
Interventions
Pars plana vitrectomy or cataract surgery.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Charles University, Czech Republiclead
- Czech Health Research Councilcollaborator
Study Sites (1)
General University Hospital in Prague
Prague, 12808, Czechia
Related Publications (10)
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.
PMID: 18299315BACKGROUNDSoupal 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.
PMID: 24401008BACKGROUNDZoppini 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.
PMID: 18571393BACKGROUNDTakao 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.
PMID: 21035886BACKGROUNDVujosevic 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.
PMID: 32113513BACKGROUNDMeister 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.
PMID: 14970398BACKGROUNDMartinez 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.
PMID: 31290435BACKGROUNDBoss 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.
PMID: 29084332BACKGROUNDWu 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.
PMID: 28680705BACKGROUNDMastropasqua 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.
PMID: 30410092BACKGROUND
Biospecimen
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.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martin Prázný, Prof.
Charles University and General University Hospital in Prague
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof.
Study Record Dates
First Submitted
February 7, 2023
First Posted
July 13, 2023
Study Start
April 1, 2022
Primary Completion
December 31, 2025
Study Completion
June 1, 2026
Last Updated
July 13, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share