Tissue Sodium in Patients With Psoriasis

NCT ID: NCT04095130

Last Updated: 2019-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

56 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-01

Study Completion Date

2019-09-17

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Psoriasis Vulgaris Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Healthy subjects

those without a condition

23Na Magnetic resonance imaging

Intervention Type DIAGNOSTIC_TEST

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

Psoriasis patients

those with a condition

23Na Magnetic resonance imaging

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

23Na Magnetic resonance imaging

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

German Heart Center

OTHER

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr. Lajos Marko

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Experimental and Clinical Research Center, Clinical Research Unit

Berlin, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 23339169 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23467095 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ChariteU-ECRC-TSS1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Research in Skin Inflammation
NCT00026741 COMPLETED
Effects of Topical SLPI on Skin Wounds
NCT00005569 COMPLETED PHASE1
Longitudinal Spatial Frequency Domain Imaging Study
NCT05672992 ACTIVE_NOT_RECRUITING NA