Investigation of the Skin Barrier in Patients With Type 1 Diabetes

Study Overview
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Brief Summary
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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.

Detailed Description
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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

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

Conditions
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Type 1 Diabetes

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cases<br>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<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TEWL | Transepidermal Water Loss measured by an Aquaflux AF1000 | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin barrier properties described with Tape Strips | Tape strips will be analyzed according to Natural Moisturizing Factors | Baseline | 
| Filaggrin mutation Status | Filaggrin DNA status regarding common SNPs in DNA | Baseline | 
| Skin pH | Measured with DermaUnit SSC3 Skin pH-Meter | Baseline | 
| Skin hydration | Measured with DermaUnit SSC3 Corneometer | Baseline | 
| Sebum content in skin | Measured with DermaUnit SSC3 Sebumeter | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dermatology, Skin Barrier Function