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OpenTrials
Completed

NCT Number: NCT04095130

Tissue Sodium in Patients With Psoriasis

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Experimental and Clinical Research Center, Clinical Research Unit

Berlin, 13125, Germany

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

23Na Magnetic resonance imaging

Diagnostic Test

Measurement of skin sodium content by non-invasive 23Na Magnetic resonance imaging.

Primary outcomes

  1. Non-invasive sodium measurement in the skin

    Time frame: 4 years

    Sodium measured in the skin by 23Na-MRI is higher in psoriasis patients vs. matched healthy individuals.

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • German Heart Center

Registry information

Official study title

Tissue Sodium Accumulation in Patients With Psoriasis: a Pilot Study

Acronym: TSS1

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Sep 19, 2019
Registry last updated
Sep 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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