Tissue Sodium in Patients With Psoriasis

Healthy Clinical Trial

— TSS1  

Official title:

Tissue Sodium Accumulation in Patients With Psoriasis: a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04095130
• Other study ID #: ChariteU-ECRC-TSS1
• Status: Completed
• Start date: July 1, 2015
• Est. completion date: September 17, 2019

Study information

• Verified date: September 2019
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: September 17, 2019
• Est. primary completion date: March 16, 2018
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy
• Psoriasis
• Psoriasis Vulgaris

Intervention

Diagnostic Test:
• 23Na Magnetic resonance imaging
Measurement of skin sodium content by non-invasive 23Na Magnetic resonance imaging.

Locations

Country	Name	City	State
Germany	Experimental and Clinical Research Center, Clinical Research Unit	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	German Heart Center

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Kleinewietfeld M, Manzel A, Titze J, Kvakan H, Yosef N, Linker RA, Muller DN, Hafler DA. Sodium chloride drives autoimmune disease by the induction of pathogenic TH17 cells. Nature. 2013 Apr 25;496(7446):518-22. doi: 10.1038/nature11868. Epub 2013 Mar 6. — View Citation

Kopp C, Linz P, Dahlmann A, Hammon M, Jantsch J, Müller DN, Schmieder RE, Cavallaro A, Eckardt KU, Uder M, Luft FC, Titze J. 23Na magnetic resonance imaging-determined tissue sodium in healthy subjects and hypertensive patients. Hypertension. 2013 Mar;61(3):635-40. doi: 10.1161/HYPERTENSIONAHA.111.00566. Epub 2013 Jan 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-invasive sodium measurement in the skin	Sodium measured in the skin by 23Na-MRI is higher in psoriasis patients vs. matched healthy individuals.	4 years