The Effect of Dietary Intervention on Endothelial Glycocalyx Integrity and Microvascular Perfusion in Patients With Psoriatic Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Endocalyx effects on endothelial glycocalyx thickness
研究概览
简要总结
The food supplement Endocalyx is considered to support the endothelial glycocalyx integrity by supplying sulfated polysaccharides, anti-oxidant enzymes and additional substrates for glycocalyx synthesis. The investigators will study the effect of Endocalyx on endothelial, vascular and left ventricular myocardial function in patients with psoriatic disease.
详细描述
Sixty patients with psoriatic disease, who are referred to the outpatient psoriasis clinic of the Attikon University Hospital, will be randomized to receive food supplement Endocalyx (4 capsules per day) (n=30) or placebo (n=30) for 4 consecutive months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Caucasian patients with psoriatic disease (plaque-type psoriasis or psoriatic arthritis)
- •Body mass index ≥18.5 Kg/m2
- •If female, patients must be non-pregnant and non-breastfeeding
排除标准
- •History of acute coronary syndrome. Coronary artery disease will be excluded by a clinical history, examination and electrocardiogram.
- •Moderate or severe valve disease
- •Primary cardiomyopathies
- •Chronic obstructive pulmonary disease
- •Chronic kidney disease
- •Liver failure
- •Malignancies
结局指标
主要结局
Endocalyx effects on endothelial glycocalyx thickness
时间窗: four months
Endocalyx effects on endothelial glycocalyx thickness as assessed by perfused boundary region (PBR, micrometers) of the sublingual arterial microvessels using Sidestream Dark Field (SDF) imaging.
次要结局
- Endocalyx effects on coronary microcirculation(four months)
- Endocalyx effects on arterial stiffness(four months)
- Endocalyx effects on left ventricular myocardial function(four months)
研究者
Ignatios Ikonomidis
Professor of Cardiology
University of Athens