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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05892640
Other study ID # 215861462341
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 1, 2022
Est. completion date June 30, 2024

Study information

Verified date June 2023
Source Josip Juraj Strossmayer University of Osijek
Contact Ines Drenjancevic, MD, PhD
Phone +38531512800
Email ines.drenjancevic@mefos.hr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date June 30, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 69 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Low-Salt Diet
Low-salt diet (LS diet) according to DASH eating plan, with sodium intake of 1500 mg (3.75 g of salt), within the period of 14 days

Locations

Country Name City State
Croatia University Hospital Osijek Osijek

Sponsors (1)

Lead Sponsor Collaborator
Josip Juraj Strossmayer University of Osijek

Country where clinical trial is conducted

Croatia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Microvascular endothelial function 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 2 weeks
Primary Frequency of peripheral T helper 17 (Th17) and regulatory lymphocytes (Treg) among parent lymphocytes sub-population Flow cytometry assessment of the frequencies of peripheral Treg and Th17 lymphocytes before and after LS diet protocol 2 weeks
Secondary Microvascular non-endothelial function Cutaneous microvascular blood flow will be measured by Laser Doppler Flowmetry in response to iontophoresis of sodium nitroprusside (SNP) before and after LS diet protocol 2 weeks
Secondary Relative amount of serum- and glucocorticoid-induced kinase 1 (SGK1) in peripheral blood mononuclear cells Relative amount of total serum- and glucocorticoid regulated kinase 1 (SGK1) in cultured cells will be measured by commercially available cell-based enzyme-linked immuno-sorbent assay (ELISA) kit before and after LS diet protocol 2 weeks
Secondary Serum Protein Concentration of Pro- and Anti-Inflammatory Cytokines Serum protein concentrations (pg/mL) of pro-inflammatory and anti-inflammatory cytokines will be measured with panel for multiplex protein quantitation before and after LS diet protocol 2 weeks
Secondary 24-hour natriuresis A 24-h urinary sodium excretion will be measured in each participant before and after LS diet protocol in order to assess compliance to the given dietary protocol 2 weeks
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