Investigation of the Skin Barrier in Patients With Type 1 Diabetes
1 other identifier
observational
98
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2020
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 14, 2020
CompletedStudy Start
First participant enrolled
February 18, 2020
CompletedFirst Posted
Study publicly available on registry
February 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 14, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 14, 2021
CompletedFebruary 3, 2022
February 1, 2022
1.3 years
February 14, 2020
February 2, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
TEWL
Transepidermal Water Loss measured by an Aquaflux AF1000
Baseline
Secondary Outcomes (5)
Skin barrier properties described with Tape Strips
Baseline
Filaggrin mutation Status
Baseline
Skin pH
Baseline
Skin hydration
Baseline
Sebum content in skin
Baseline
Study Arms (2)
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
Eligibility Criteria
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.
You may qualify if:
- Diagnosed with type 1 diabetes, more than 6 months ago
You may not qualify if:
- 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:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jannet Svenssonlead
Study Sites (2)
Steno Diabetes Center Copenhagen
Gentofte Municipality, Capital Region, 2820, Denmark
Department of Pediatrics, Herlev Hospital
Herlev, Capital Region, 2730, Denmark
Related Links
Biospecimen
Buccal Swab for DNA extraction
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD, PhD, Assistant Professor
Study Record Dates
First Submitted
February 14, 2020
First Posted
February 21, 2020
Study Start
February 18, 2020
Primary Completion
June 14, 2021
Study Completion
June 14, 2021
Last Updated
February 3, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share