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

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Status

Enrolling

Conditions

Type 1 Diabetes

Diabetic Retinopathy

Treatments

Diagnostic Test: Optical Coherence Tomography (OCT) Angiography

Study type

Observational

Funder types

Other

Identifiers

NCT04888598

IIBSP-RET-2020-69

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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