TSS1: Tissue Sodium in Patients With Psoriasis

Sponsor
Charite University, Berlin, Germany (Other)
Overall Status
Completed
CT.gov ID
NCT04095130
Collaborator
German Heart Center (Other)
56
1
50.6
1.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: 23Na Magnetic resonance imaging

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 Design

Study Type:
Observational
Actual Enrollment :
56 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Tissue Sodium Accumulation in Patients With Psoriasis: a Pilot Study
Actual Study Start Date :
Jul 1, 2015
Actual Primary Completion Date :
Mar 16, 2018
Actual Study Completion Date :
Sep 17, 2019

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Experimental and Clinical Research Center, Clinical Research Unit Berlin Germany 13125

Sponsors and Collaborators

  • Charite University, Berlin, Germany
  • German Heart Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Dr. Lajos Marko, Principal Investigator, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT04095130
Other Study ID Numbers:
  • ChariteU-ECRC-TSS1
First Posted:
Sep 19, 2019
Last Update Posted:
Sep 19, 2019
Last Verified:
Sep 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dr. Lajos Marko, Principal Investigator, Charite University, Berlin, Germany
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 19, 2019