An observational study in Type 1 Diabetes, sponsored by Jannet Svensson. Completed at 2 sites in Denmark. Open to participants aged 2 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-03.
Sponsored by Jannet Svensson · Observational
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.
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:
3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.
This study's enrollment of 98 is below the median of 125 across 792 observational studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Jannet Svensson is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Cases:
Inclusion Criteria:
Exclusion Criteria:
Controls:
Inclusion Criteria:
Exclusion Criteria are equal to exclusion criteria in cases
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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
TEWL
Transepidermal Water Loss measured by an Aquaflux AF1000
Time frame: Baseline
Skin barrier properties described with Tape Strips
Tape strips will be analyzed according to Natural Moisturizing Factors
Time frame: Baseline
Filaggrin mutation Status
Filaggrin DNA status regarding common SNPs in DNA
Time frame: Baseline
Skin pH
Measured with DermaUnit SSC3 Skin pH-Meter
Time frame: Baseline
Skin hydration
Measured with DermaUnit SSC3 Corneometer
Time frame: Baseline
Sebum content in skin
Measured with DermaUnit SSC3 Sebumeter
Time frame: Baseline
Plan to share: No
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Jannet Svensson