Investigation of the Skin Barrier in Patients With Type 1 Diabetes
NCT ID: NCT04280315
Last Updated: 2022-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
98 participants
OBSERVATIONAL
2020-02-18
2021-06-14
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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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
No interventions assigned to this group
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
No interventions assigned to this group
Eligibility Criteria
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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
* 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:
2 Years
ALL
Yes
Sponsors
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Jannet Svensson
OTHER
Responsible Party
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Jannet Svensson
MD, PhD, Assistant Professor
Locations
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Steno Diabetes Center Copenhagen
Gentofte Municipality, Capital Region, Denmark
Department of Pediatrics, Herlev Hospital
Herlev, Capital Region, Denmark
Countries
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Related Links
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Other Identifiers
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SkinBarrier_30092019
Identifier Type: -
Identifier Source: org_study_id
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