NCT04888598招募中不适用
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 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Vessel density
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Vessel density
时间窗: 3 months
Density of retinal vessels and perfusion in the macula
次要结局
- Vessel density(6 months)
研究者
研究点 (2)
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