Type 1 DiabetesNCT04280315
Investigation of the Skin Barrier in Patients With Type 1 Diabetes
An observational study of Type 1 Diabetes, run by Jannet Svensson at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes
- How many people
- 98 participants
- Where
- 2 sitesDenmark
- Study dates
- 18 Feb 2020to 14 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- Diagnosed with type 1 diabetes, more than 6 months ago
- 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
Who cannot join
- 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:
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Steno Diabetes Center Copenhagen
Gentofte Municipality, Capital Region, 2820
Department of Pediatrics, Herlev Hospital
Herlev, Capital Region, 2730
About this study
Official title: Investigation of the Skin Barrier in Patients With Type 1 Diabetes - a Case-control Study
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.
Read the detailed description
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
- Conditions
- Type 1 Diabetes
- Keywords
- Dermatology, Skin Barrier Function
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
TEWL
Transepidermal Water Loss measured by an Aquaflux AF1000
Measured: Baseline
Secondary outcomes (5)
Skin barrier properties described with Tape Strips
Tape strips will be analyzed according to Natural Moisturizing Factors
Measured: Baseline
Filaggrin mutation Status
Filaggrin DNA status regarding common SNPs in DNA
Measured: Baseline
Skin pH
Measured with DermaUnit SSC3 Skin pH-Meter
Measured: Baseline
Skin hydration
Measured with DermaUnit SSC3 Corneometer
Measured: Baseline
Sebum content in skin
Measured with DermaUnit SSC3 Sebumeter
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start18 Feb 2020
- Primary completion14 Jun 2021
- Study completion14 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jannet Svensson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jannet Svensson, Copenhagen University Hospital at Herlev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04280315
- Sponsor's protocol ID
- SkinBarrier_30092019
- Status last verified
- Feb 2022
- First submitted
- 14 Feb 2020
- Last updated
- 3 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Skin Barrier in Patients With Type 1 Diabetes - a Case-control Study
- ClinicalTrials.gov ID
- NCT04280315
- Acronym / sponsor ID
- SkinBarrier_30092019
- Conditions
- Type 1 Diabetes
- Keywords
- Dermatology, Skin Barrier Function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Jannet SvenssonUniversity, hospital or other
- Study start
- 18 Feb 2020 (actual)
- Primary completion
- 14 Jun 2021 (actual)
- Study completion
- 14 Jun 2021 (actual)
- First posted
- 21 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- Diagnosed with type 1 diabetes, more than 6 months ago
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
TEWL
Time frame: Baseline
Transepidermal Water Loss measured by an Aquaflux AF1000
5 secondary outcomes
Skin barrier properties described with Tape Strips
Time frame: Baseline
Filaggrin mutation Status
Time frame: Baseline
Skin pH
Time frame: Baseline
Skin hydration
Time frame: Baseline
Sebum content in skin
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2022.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes, run by Jannet Svensson at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TEWL (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2022.