Tissue Sodium in Patients With Psoriasis (TSS1)

September 18, 2019 updated by: Dr. Lajos Marko, Charite University, Berlin, Germany

Tissue Sodium Accumulation in Patients With Psoriasis: a Pilot Study

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.

Study Overview

Status

Completed

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

Observational

Enrollment (Actual)

56

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 13125
        • Experimental and Clinical Research Center, Clinical Research Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy subjects
those without a condition
Diagnostic test: 23Na Magnetic resonance imaging
Measurement of skin sodium content by non-invasive 23Na Magnetic resonance imaging.
Psoriasis patients
those with a condition
Diagnostic test: 23Na Magnetic resonance imaging
Measurement of skin sodium content by non-invasive 23Na Magnetic resonance imaging.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

German Heart Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2015

Primary Completion (Actual)

March 16, 2018

Study Completion (Actual)

September 17, 2019

Study Registration Dates

First Submitted

September 17, 2019

First Submitted That Met QC Criteria

September 18, 2019

First Posted (Actual)

September 19, 2019

Study Record Updates

Last Update Posted (Actual)

September 19, 2019

Last Update Submitted That Met QC Criteria

September 18, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ChariteU-ECRC-TSS1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Planned to share all IPD that underlie results in a publication.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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