Tissue Sodium in Patients With Psoriasis (TSS1)
Tissue Sodium Accumulation in Patients With Psoriasis: a Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Berlin, Germany, 13125
- Experimental and Clinical Research Center, Clinical Research Unit
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Healthy patients recruited locally (invitation to volunteer sent to workers of the Charié University Clinic and the Max Delbrück Center for Molecular Medicine).
Psoriasis patients are recruited who are treated at the Department of Dermatology, Venerology and Allergology, Charité Medical Faculty, Berlin, Germany, Immanuel Krankenhaus Berlin, Medical Centre for Rheumatology and Clinical Immunology, Berlin, Germany and the Helios Clinic Berlin-Buch, Berlin, Germany.
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Healthy subjects
those without a condition
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Measurement of skin sodium content by non-invasive 23Na Magnetic resonance imaging.
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Psoriasis patients
those with a condition
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Measurement of skin sodium content by non-invasive 23Na Magnetic resonance imaging.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Non-invasive sodium measurement in the skin
Time Frame: 4 years
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Sodium measured in the skin by 23Na-MRI is higher in psoriasis patients vs. matched healthy individuals.
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4 years
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Collaborators and Investigators
Collaborators
Publications and helpful links
General Publications
- Kopp C, Linz P, Dahlmann A, Hammon M, Jantsch J, Muller 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ChariteU-ECRC-TSS1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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