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Investigation of the Skin Barrier in Patients With Type 1 Diabetes

2. februar 2022 opdateret af: Jannet Svensson

Investigation of the Skin Barrier in Patients With Type 1 Diabetes - a Case-control Study

This study is a case-control study comparing the skin barrier between 50 T1D patients with healthy controls in 3 age-strata including both pediatric and adult patients.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

The skin is a crucial barrier against external allergens and irritants. Therefore the function of the skin barrier is central regarding evolvement of eczema. In patients with type 1 diabetes (T1D) using insulin pumps and/or glucose sensor, eczema is unfortunately a frequent reaction. The skin consists of three layers: epidermis, dermis and subcutaneous fat, whereas epidermis is most determining regarding skin barrier. Epidermis can further be subdivided, where stratum corneum (SC) is the outer part, which means most regarding vulnerability towards external allergens.

The function of the skin barrier can be investigated by non-invasive methods using transepidermal water loss (TEWL), which shows the water vapour flux from the skin. Besides SC can be determined using the tape strip method, where few SC cells are peeled off and thereby can be analyzed with mass-spectrometry. Natural moisturizing factors (NMF) is though one of the very important functionalities of the SC, which are determined by the amount of 2-pyrrolidone-5-carboxylic acid (PCA). Besides, the lipid distribution, presence of antimicrobial peptide and cytokine response give as well important information regarding the skin barrier.

Dermatological manifestations of T1D are quite frequent and have been shown to be related to glycemic control, placing dermatological manifestations as a precursor of other microvascular complications11. There is a lack of studies regarding skin barrier function in patients with T1D, and especially in a pediatric study population. Therefore, this case-control study will be conducted investigating skin barrier function in pediatric patients with T1D compared to healthy controls in order to both meet this lack of knowledge, but as well to improve the prevention of skin problems to devices used in T1D-treatment.

The examination program of just one visit per participant consists of:

  • TEWL-measure at forearm and buttock
  • Buccal swab regarding filaggrin gene status
  • Microbiological swab from the skin at forearm and buttock
  • 2X11 tape strips from the skin at foream and buttock to be analyzed for NMF, Lipid, Cytokines, Antimicrobial peptide and Dermal Topographical Index as well as protein content using SquameScan
  • Measure of skin PH, hydration and sebum content at forearm and buttock
  • Capillary Blood Glucose
  • Survey regarding atopic and dermatological symptoms

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

98

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Danmark
    • Region Hovedstaden
      • Gentofte, Region Hovedstaden, Danmark, 2820
        • Steno Diabetes Center Copenhagen
      • Herlev, Region Hovedstaden, Danmark, 2730
        • Department of Pediatrics, Herlev Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

2 år og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Study Population are included from the Pediatric department in the diabetes group for patients and primarily in the neurogroup for controls. Adult cases are included from Steno Diabetes Center Copenhagen and adult controls as parents to patients included.

Beskrivelse

Cases:

Inclusion Criteria:

  • Diagnosed with type 1 diabetes, more than 6 months ago

Exclusion Criteria:

  • Skin lesions at both buttocks and forearms so investigation can not be done
  • Known skin diseases with decreased barrier function like atopic dermatitis, psoriasis and allergic contact dermatitis
  • Active infectious disease
  • Use of immunosuppressive medication e.g. steroids
  • Lack of language competence in Danish

Controls:

Inclusion Criteria:

  • Diagnosed with Tourettes or Headache OR sibling for patients in the 1813-clinic at Pediatric Emergency Toom OR Hospitalized patients at Pediatric department OR Parents to alle these

Exclusion Criteria are equal to exclusion criteria in cases

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Cases

Cases are patients with type 1 diabetes in three age strata:

  • 20 participants in the age of 2-10 years
  • 20 participants in the age of 11-20 years
  • 10 participants with more than 30 years of diabetes duration
Controls
Controls are age and sexmatched with the cases and are recruited from the neuropediatric clinic at Herlev Hospital as well as relatives and parents of patients in the whole Pediatric Department

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
TEWL
Tidsramme: Baseline
Transepidermal Water Loss measured by an Aquaflux AF1000
Baseline

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Skin barrier properties described with Tape Strips
Tidsramme: Baseline
Tape strips will be analyzed according to Natural Moisturizing Factors
Baseline
Filaggrin mutation Status
Tidsramme: Baseline
Filaggrin DNA status regarding common SNPs in DNA
Baseline
Skin pH
Tidsramme: Baseline
Measured with DermaUnit SSC3 Skin pH-Meter
Baseline
Skin hydration
Tidsramme: Baseline
Measured with DermaUnit SSC3 Corneometer
Baseline
Sebum content in skin
Tidsramme: Baseline
Measured with DermaUnit SSC3 Sebumeter
Baseline

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Jannet Svensson

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

18. februar 2020

Primær færdiggørelse (Faktiske)

14. juni 2021

Studieafslutning (Faktiske)

14. juni 2021

Datoer for studieregistrering

Først indsendt

14. februar 2020

Først indsendt, der opfyldte QC-kriterier

19. februar 2020

Først opslået (Faktiske)

21. februar 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. februar 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. februar 2022

Sidst verificeret

1. februar 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SkinBarrier_30092019

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Betingelser

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Sponsor / samarbejdspartnere

Placeringer

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