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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-01

Study Completion Date

2024-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Type 1 Diabetes Diabetic Retinopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Type 1 diabetic patients

Recently diagnosed type 1 diabetes patients

Optical Coherence Tomography (OCT) Angiography

Intervention Type DIAGNOSTIC_TEST

Measurement of retinal vessel density and distribution in the macula using new generation OCT device

Interventions

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Optical Coherence Tomography (OCT) Angiography

Measurement of retinal vessel density and distribution in the macula using new generation OCT device

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No