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临床试验/NCT05892640
NCT05892640招募中不适用

Effects of Low Salt Dietary Intake on Th17-Mediated Inflammation and Vascular Reactivity in Patients With Psoriasis

Josip Juraj Strossmayer University of Osijek2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
2
主要终点
Microvascular endothelial function

研究概览

简要总结

Psoriasis presents an independent cardiovascular risk factor characterized by chronic low-grade systemic inflammation and oxidative stress which altogether might lead to endothelial dysfunction. It has been reported that increased oxidative stress has a pivotal role in high dietary sodium-induced endothelial dysfunction. Previous studies on sodium accumulation in psoriatic skin lesions and the sodium-induced augmentation in Th17 immune response, raise the question on the complex interplay between sodium and psoriasis, especially in the context of cardiovascular morbidity.

This study aimed to investigate the effect of a 2-week low-salt diet on endothelium-dependent and endothelium-independent cutaneous microvascular vasodilation and Th17-Mediated Inflammation in patients with psoriasis vulgaris.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 69 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with diagnosed psoriasis vulgaris
  • subjects do not use topical corticosteroid therapy for at least 2 weeks before inclusion in the study and 2 weeks during the study
  • subjects do not use systemic or biological therapy for at least 3 months before and 2 weeks during the study.

排除标准

  • age < 18 years
  • existence of other immune-mediated diseases (with the exception of autoimmune thyroid diseases and psoriatic arthritis - people with these comorbidities can be included)
  • malignant diseases
  • current infectious diseases and allergic reactions within 6 weeks before the start of the study

结局指标

主要结局

Microvascular endothelial function

时间窗: 2 weeks

Cutaneous microvascular blood flow will be measured by Laser Doppler Flowmetry in response to vascular occlusion (post occlusive reactive hyperaemia - PORH), in response to iontophoresis of acetylcholine (ACh) and local thermal hyperemia (LTH) before and after LS diet protocol

Frequency of peripheral T helper 17 (Th17) and regulatory lymphocytes (Treg) among parent lymphocytes sub-population

时间窗: 2 weeks

Flow cytometry assessment of the frequencies of peripheral Treg and Th17 lymphocytes before and after LS diet protocol

次要结局

  • Microvascular non-endothelial function(2 weeks)
  • Relative amount of serum- and glucocorticoid-induced kinase 1 (SGK1) in peripheral blood mononuclear cells(2 weeks)
  • Serum Protein Concentration of Pro- and Anti-Inflammatory Cytokines(2 weeks)
  • 24-hour natriuresis(2 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ines Drenjancevic

Vice Dean for Science, Faculty of Medicine Josip Juraj Strossmayer University of Osijek

Josip Juraj Strossmayer University of Osijek

研究点 (2)

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