Investigation of the Skin Barrier in Patients With Type 1 Diabetes
Investigation of the Skin Barrier in Patients With Type 1 Diabetes - a Case-control Study
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Region Hovedstaden
-
Gentofte, Region Hovedstaden, Dinamarca, 2820
- Steno Diabetes Center Copenhagen
-
Herlev, Region Hovedstaden, Dinamarca, 2730
- Department of Pediatrics, Herlev Hospital
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
|
Cases
Cases are patients with type 1 diabetes in three age strata:
|
|
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
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
TEWL
Periodo de tiempo: Baseline
|
Transepidermal Water Loss measured by an Aquaflux AF1000
|
Baseline
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Skin barrier properties described with Tape Strips
Periodo de tiempo: Baseline
|
Tape strips will be analyzed according to Natural Moisturizing Factors
|
Baseline
|
|
Filaggrin mutation Status
Periodo de tiempo: Baseline
|
Filaggrin DNA status regarding common SNPs in DNA
|
Baseline
|
|
Skin pH
Periodo de tiempo: Baseline
|
Measured with DermaUnit SSC3 Skin pH-Meter
|
Baseline
|
|
Skin hydration
Periodo de tiempo: Baseline
|
Measured with DermaUnit SSC3 Corneometer
|
Baseline
|
|
Sebum content in skin
Periodo de tiempo: Baseline
|
Measured with DermaUnit SSC3 Sebumeter
|
Baseline
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- SkinBarrier_30092019
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Diabetes tipo 1
-
Oxford Brookes UniversityUniversity of OxfordTerminadoActividad física | Salud Mental Bienestar 1 | Función Cognitiva 1, Social | Academic Attainment | Fitness TestingReino Unido
-
Merck Sharp & Dohme LLCReclutamientoCáncer de pulmón de células no pequeñas | Tumores sólidos | Muerte celular programada-1 (PD1, PD-1) | Ligando 1 de muerte celular programada 1 (PDL1, PD-L1) | Ligando 2 de muerte celular programada 1 (PDL2, PD-L2)Japón
-
Rambam Health Care CampusIsrael Science FoundationTerminado
-
Alvotech Swiss AGTerminado
-
PfizerTerminado
-
SanionaTerminado
-
Calliditas Therapeutics ABEurofins Optimed; York Bioanalytical SolutionTerminado
-
Calliditas Therapeutics ABTerminado
-
Reproductive Medicine Associates of New JerseyTerminadoCada paciente es a la vez caso y control | 1 embrión será biopsiado y 1 embrión noEstados Unidos
-
CinnagenTerminadoBioequivalencia | Fase 1Irán (República Islámica de