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

Recruiting

• Conditions: Type 1 Diabetes; Diabetic Retinopathy
• Interventions: Diagnostic Test: Optical Coherence Tomography (OCT) Angiography

• Registration Number: NCT04888598
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-12
• Study First Submitted QC: 2021-05-12
• Study First Posted: 2021-05-17
• Study Start: 2021-06-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-15
• Last Update Posted: 2023-03-16
• Primary Completion: 2023-12
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Type 1 diabetic patients	Optical Coherence Tomography (OCT) Angiography	Recently diagnosed type 1 diabetes patients

Primary Outcome Measures

Name	Time	Method
Vessel density	3 months	Density of retinal vessels and perfusion in the macula

Secondary Outcome Measures

Name	Time	Method
Vessel density	6 months	Density of retinal vessels and perfusion in the macula

Trial Locations

Locations (2)

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain

Hospital Universitari Arnau de Vilanova; 🇪🇸 Lleida, Spain