Clinical trial NCT04888598: Microvascular Changes in OCT-angiography in Type 1 Diabetes Mellitus at the Onset of the Disease and After Optimization of Glycemic Control.
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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type 1 Diabetes
Diabetic Retinopathy
Keywords: OCT-A
OCT Angiography
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
Collaborators: name: Hospital Arnau de Vilanova
First posted: 2021-05-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with type 1 diabetes who meet all the inclusion criteria and none of the exclusion criteria

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Vessel density
timeFrame: 3 months
Secondary outcomes:
measure: Vessel density
timeFrame: 6 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Lleida
country: Spain
facility: Hospital Universitari Arnau de Vilanova
Study officials:
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Ignacio Salvador, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: Garg S, Davis R. Diabetic Retinopathy Screening Update. Clinical Diabetes. 2009;27(4):140-145. doi:10.2337/diaclin.27.4.140
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.
citation: 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.
citation: 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.