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.

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau2 sites in 1 country20 target enrollmentJune 1, 2021

ConditionsType 1 Diabetes Diabetic Retinopathy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Type 1 Diabetes
Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Enrollment: 20
Locations: 2
Primary Endpoint: Vessel density
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 1, 2021

End Date

June 2024

Last Updated

3 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

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

Responsible Party

Sponsor

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