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Diabetes ComplicationsNCT05944640

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

An observational study of Diabetes Complications, run by Charles University, Czech Republic at 1 site in Czechia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Complications
What is being tested?
Intraocular surgery
Type of treatment
Surgery or procedure
How many people
213 participants
Where
1 siteCzechia
Study dates
1 Apr 2022to 1 Jun 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Martin Prázný, Prof. contact

+420737122570

mpra@lf1.cuni.cz

Petra Svozílková, Prof. contact

+420604801153

petra.svozilkova@lf1.cuni.cz

Czechia1 site, 1 recruiting

  • General University Hospital in Prague

    Prague, 12808

    Martin Prázný, Prof., +420737122570, mpra@lf1.cuni.cz

    Recruiting

Other trials in Czechia

About this study

Official title: 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.

Read the 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.

Being tested
Intraocular surgery
Keywords
biomarkers, retinopathy, miRNA, diabetes mellitus, glucose variability
Medical subject headings
Diabetes Complications, Retinal Diseases, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intraocular surgeryProcedure or surgery

    Pars plana vitrectomy or cataract surgery.

Study groups in NCT05944640
Study groupRoleWhat they receive
Patients with DRAdult 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.
Receives: Procedure: Intraocular surgery
Patients without DRAdult 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.
Receives: Procedure: Intraocular surgery
Control groupSubjects 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.
Receives: Procedure: Intraocular surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. miRNA

    miRNA expression measuer by real-time PCR method in plasma and vitreous samples (units: threshold cycle)

    Measured: Year 2025

  2. TIR

    Percentage of time in target ranges

    Measured: Year 2025

Secondary outcomes (3)

  1. miRNA expression differences

    miRNA expression differences analysis between diabetic patients with and without diabetic retinopathy (units: fold change)

    Measured: Year 2025

  2. Glycemic variability

    Expressed as the standard deviation

    Measured: Year 2025

  3. Mean sensor glucose concentration

    Measured by rtCGM

    Measured: Year 2025

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2023
  2. Study start1 Apr 2022
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion1 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
213 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05944640
Sponsor's protocol ID
NU22-01-00077
Status last verified
Jul 2023
First submitted
7 Feb 2023
Last updated
13 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 18299315

  • 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.

    PubMed 24401008

  • 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.

    PubMed 18571393

  • 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.

    PubMed 21035886

  • 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.

    PubMed 32113513

  • 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.

    PubMed 14970398

  • 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.

    PubMed 31290435

  • 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.

    PubMed 29084332

  • 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.

    PubMed 28680705

  • 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.

    PubMed 30410092

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Complications, run by Charles University, Czech Republic at 1 site in Czechia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Martin Prázný, Prof. (+420737122570, mpra@lf1.cuni.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

miRNA (time frame: Year 2025). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05944640, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2023.

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