Status:
UNKNOWN
Microvascular Changes in OCT-angiography in Type 1 Diabetes Mellitus at the Onset of the Disease and After Optimization of Glycemic Control.
Lead Sponsor:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborating Sponsors:
Hospital Arnau de Vilanova
Conditions:
Type 1 Diabetes
Diabetic Retinopathy
Eligibility:
All Genders
18+ years
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04888598
Start Date
June 1 2021
End Date
June 1 2024
Last Update
March 16 2023
Active Locations (2)
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1
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08041
2
Hospital Universitari Arnau de Vilanova
Lleida, Spain, 25198