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.
| Registry | NCT04888598 |
|---|---|
| Status | Unknown |
| Study type | Observational |
| Enrollment | 20 (Estimated) |
| Sponsor | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (Other); collaborators: Hospital Arnau de Vilanova |
| Conditions | Type 1 Diabetes, Diabetic Retinopathy |
| Interventions | Optical Coherence Tomography (OCT) Angiography (Diagnostic test) |
| Dates | start 2021-06-01, primary completion 2023-12-01 (estimated), completion 2024-06-01 (estimated), first posted 2021-05-17, last updated 2023-03-16 |
| Locations | 2 sites in Spain |
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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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Type 1 diabetic patients | Diagnostic Test: Optical Coherence Tomography (OCT) Angiography | Recently diagnosed type 1 diabetes patients |
Sex: All, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| Hospital de la Santa Creu i Sant Pau | Barcelona | Spain | Recruiting |
| Hospital Universitari Arnau de Vilanova | Lleida | Spain | Recruiting |