Tissue Sodium in Patients With Psoriasis

Completed

• Conditions: Healthy; Psoriasis Vulgaris
• Interventions: Diagnostic Test: 23Na Magnetic resonance imaging

• Registration Number: NCT04095130
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

Sodium can be buffered in the skin, which mechanism is altered during aging and in certain diseases such as hypertension. High salt environment can promote autoimmunity by expanding pathogenic IL-17 producing T helper (Th17) cells. Psoriasis is a relapsing and remitting inflammatory autoimmune disease affecting the skin and joints and involves proinflammatory Th17 cells. Here we tested the hypothesis if psoriatic skin has a higher sodium content in humans.

Detailed Description

The cytokine interleukin-17A (IL-17A) is a crucial player in the pathogenesis of the autoimmune disease of psoriasis. This neutrophil recruiting cytokine is produced by IL-17A producing CD4+ T cells (Th17) and gamma/delta T cells of the skin and evokes an inflammation circuit finally leading to the classical clinical picture of psoriasis with hyper- and parakeratosis, erythema, scaling and neutrophil abscess formation.

Besides genetic factors, lifestyle factors are relevant and decide if an autoimmune disease becomes manifest. It was shown previously that increased salt (sodium chloride, NaCl) concentrations boost the induction of murine and human Th17 cells. However, more - and also clinical - studies are needed to understand the correlation between salt content and IL-17A in autoimmune diseases.

This study investigates the hypothesis if skin sodium content in human psoriasis is increased in order to get further insight into the IL-17A-salt-interplay.

Study Timeline

• Study Start: 2015-07-01
• Primary Completion: 2018-03-16
• Status Verified: 2019-09
• Study Completion: 2019-09-17
• Study First Submitted: 2019-09-17
• Study First Submitted QC: 2019-09-18
• Last Update Submitted: 2019-09-18
• Study First Posted: 2019-09-19
• Last Update Posted: 2019-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• Age: 18-80
• Body mass index (BMI) 18.5- 40 kg/m2
• Glomerular filtration rate >60 ml/min/1.73m2

Exclusion Criteria

• Diagnosed or treated hypertension and/or blood pressure above 140/90 at screening
• Palpable peripheral oedema during phyisical examination at screening
• Any type of diabetes mellitus and/or HgbA1c>6.5% at screening
• Subjects with a thyroid-stimulating hormone >4.2 mU/L at screening
• Psoriasis patients treated with systemic corticosteroids, chemotherapy agent (methothrexate) or with any kind of biologics/biosimilars
• Subjects with acute disease
• Pregnant or lactating women
• Metal or medical device implant in the body
• Tattoo on the lower extremities
• Subjects with a history of drug or alcohol abuse
• Subjects who are legal incapacitated or their circumstances do not enable the patient to fully understand the nature, significance and scope of this study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy subjects	23Na Magnetic resonance imaging	those without a condition
Psoriasis patients	23Na Magnetic resonance imaging	those with a condition

Primary Outcome Measures

Name	Time	Method
Non-invasive sodium measurement in the skin	4 years	Sodium measured in the skin by 23Na-MRI is higher in psoriasis patients vs. matched healthy individuals.

Trial Locations

Locations (1)

Experimental and Clinical Research Center, Clinical Research Unit; 🇩🇪 Berlin, Germany