The Effect of the Glycemic Variability on Macular Retinal Microcirculation and Cognitive Functions in Patient With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Macular capillary density in the external deep capillary network
研究概览
简要总结
Revadiab is case-control study aimed to demonstrate that retinal capillary density is altered in patients with type 1 diabetes with glycemic variability compared to those with comparable glycemic control without glycemic variability. An OCT angiography will be used to precisely evaluate retinal capillary density.
A secondary objective will be to evaluate if glycemic variability is associated with cognitive dysfunction, using a neuro psychologic evaluation.
详细描述
HbA1c doesn't explain all the microvascular complications of diabetes, especially microvascular complications. Glycemic variability is associated with increased oxidative stress, free radicals and endothelial dysfunction; it contributes to the pathogenesis of diabetic complications.
The relationship between glycemic variability and microangiopathic complications especially retinal but also neurological, needs to be studied.
The principal objective of Revadiab study is to demonstrate a correlation between glycemic variability and macular retinal microcirculation in patient with type 1 diabetes.
The secondary objective is to search a correlation between glycemic variability and :
- Alteration of cognitive functions.
- Severity of peripheral diabetic retinopathy and retinal neuronal damage.
- Other micro and macro angiopathic complications.
- Oxidative stress and inflammation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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 ≥ 18 years
- •Type 1 diabetes (T1D)
- •Using Free FreeStyle
- •Diabete evolving for 10 years or more
- •Case: Patients with glycemic variability, defined by a coefficient of variation (CV) > 36%, calculated from continuous glucose measurements data by Free Style Libre® (Abbott)
- •Controls: Patients without glycemic variability, defined by a coefficient of variation (CV) ≤ 36%, calculated from Free Style Libre® data and matched to patients in the Case group for HbA1c (+/- 0.5%)
排除标准
- •Type 2 diabetic patient
- •Corticotherapy
- •Comorbidity like cancer
- •Antecedent of vitreoretinal pathology
- •Antecedent of vitreoretinal surgery
- •Important cataract, with an important opacity that prevents a reliable evaluation of capillary density in OCT angio
- •Pregnant or lactating woman
结局指标
主要结局
Macular capillary density in the external deep capillary network
时间窗: 3 months
Macular capillary density in the external deep capillary network measured by OCT-Angiography (no later than 3 months after inclusion)
次要结局
- Markers of inflammation(3 months)
- Haemorrhage, retina tractional detachment, neovascular glaucoma(3 months)
- Renal function evaluation(3 months)
- Number of severe hypoglycemia(3 months)
- Layer thickness reduction of the ganglion cells(3 months)
- Occurrence of neovascular complications(3 months)
- Evaluation of peripheral neuropathy(3 months)
- Oxidative stress markers(3 months)
- Macular capillary density in the deep capillary and deep capillary network(3 months)
- Macular edema presence(3 months)
- Diabetic retinopathy stage(3 months)
- Development of pre-retinal neovascular vessels and/or pre-papillary(3 months)
- Ischemic cardiopathy(3 months)
- Area of the central avascular zone(3 months)