Microvascular Changes in OCT-angiography in Type 1 Diabetes Mellitus at the Onset of the Disease and After Optimization of Glycemic Control.

Type 1 Diabetes Clinical Trial

Official title:

Study of the Microvascular Changes in the Retina Measured by Optical Coherence Tomography (OCT) - Angiography in Patients With Type 1 Diabetes Mellitus at the Onset of the Disease and After Optimization of Glycemic Control.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04888598
• Other study ID #: IIBSP-RET-2020-69
• Status: Recruiting
• Start date: June 1, 2021
• Est. completion date: June 2024

Study information

• Verified date: March 2023
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: Ignacio Salvador, MD
• Phone: +34 93 553 74 90
• Email: isalvador[@]santpau.cat
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objective of the study is to evaluate the differences in the retinal microcirculation measured by OCT-Angiography in patients with type 1 diabetes between the diagnosis of the disease and after 3 months of insulin treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with Type 1 Diabetes at diagnosis of the disease (less than 7 days after diagnosis)

• Age equal to or greater than 18 years

• Signature of the informed consent by the patient / legal guardian.

Exclusion Criteria:

• Metabolic situation of ketosis or ketoacidosis, according to clinical criteria established in the protocol of the Endocrinology and Nutrition Service. The patient will be a candidate once the ketonemia is absent (value <1 mmol / L).

• Previous diagnosis of dyslipidemia and any previous lipid-lowering treatment

• Previous diagnosis of hypertension and any previous hypotensive treatment

• Previous diagnosis of any form of cardiovascular disease, including heart failure.

• Previous kidney disease, and presence of advanced kidney failure (estimated glomerular filtration rate <60 ml / min)

• Presence of diabetic retinopathy identifiable by conventional eye fundus or retinography, or other concomitant retinal vascular pathology (hypertensive retinopathy, venous occlusion, arterial obstruction, etc.)

• History or presence of retinal pathology that may alter its structure and / or the validity of the measurements (retinal detachment, epiretinal membrane, high myopia -understood as an axial length greater than or equal to 26mm measured by "IOL Master" biometry-, neovascular membrane, choroidal tumors, etc.)

• History of posterior uveitis or retinal vasculitis

• Glaucoma and neuro-ophthalmological pathology that can alter the neuroretinal structures.

• Refractive media opacity that prevents a correct acquisition of images and, therefore, their evaluation

• Dementia or intellectual disability that prevent proper collaboration when acquiring images

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetic Retinopathy
• Type 1 Diabetes

Intervention

Diagnostic Test:
• Optical Coherence Tomography (OCT) Angiography
Measurement of retinal vessel density and distribution in the macula using new generation OCT device

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital Universitari Arnau de Vilanova	Lleida

Sponsors (2)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	Hospital Arnau de Vilanova

Country where clinical trial is conducted

Spain, 

References & Publications (5)

Dimitrova G, Chihara E, Takahashi H, Amano H, Okazaki K. Quantitative Retinal Optical Coherence Tomography Angiography in Patients With Diabetes Without Diabetic Retinopathy. Invest Ophthalmol Vis Sci. 2017 Jan 1;58(1):190-196. doi: 10.1167/iovs.16-20531. — View Citation

Garg S, Davis R. Diabetic Retinopathy Screening Update. Clinical Diabetes. 2009;27(4):140-145. doi:10.2337/diaclin.27.4.140

Rodrigues TM, Marques JP, Soares M, Simao S, Melo P, Martins A, Figueira J, Murta JN, Silva R. Macular OCT-angiography parameters to predict the clinical stage of nonproliferative diabetic retinopathy: an exploratory analysis. Eye (Lond). 2019 Aug;33(8):1240-1247. doi: 10.1038/s41433-019-0401-7. Epub 2019 Mar 22. — View Citation

van Hecke MV, Dekker JM, Stehouwer CD, Polak BC, Fuller JH, Sjolie AK, Kofinis A, Rottiers R, Porta M, Chaturvedi N; EURODIAB prospective complications study. Diabetic retinopathy is associated with mortality and cardiovascular disease incidence: the EURODIAB prospective complications study. Diabetes Care. 2005 Jun;28(6):1383-9. doi: 10.2337/diacare.28.6.1383. — View Citation

Yau JW, Rogers SL, Kawasaki R, Lamoureux EL, Kowalski JW, Bek T, Chen SJ, Dekker JM, Fletcher A, Grauslund J, Haffner S, Hamman RF, Ikram MK, Kayama T, Klein BE, Klein R, Krishnaiah S, Mayurasakorn K, O'Hare JP, Orchard TJ, Porta M, Rema M, Roy MS, Sharma T, Shaw J, Taylor H, Tielsch JM, Varma R, Wang JJ, Wang N, West S, Xu L, Yasuda M, Zhang X, Mitchell P, Wong TY; Meta-Analysis for Eye Disease (META-EYE) Study Group. Global prevalence and major risk factors of diabetic retinopathy. Diabetes Care. 2012 Mar;35(3):556-64. doi: 10.2337/dc11-1909. Epub 2012 Feb 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vessel density	Density of retinal vessels and perfusion in the macula	3 months
Secondary	Vessel density	Density of retinal vessels and perfusion in the macula	6 months