Atopic Dermatitis/EczemaAD-IFNCT03003793
Insulin Sensitivity in Patients With Atopic Dermatitis
An observational study of Atopic Dermatitis/Eczema and Type 2 Diabetes, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
Trial summary
The incidence of atopic dermatitis and type 2 diabetes, respectively, has increased over many years. Novel research shows an association between the two conditions. While this relationship at least in theory can be explained by lifestyle factors, there is reason to believe that other pathophysiological mechanisms are… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis/Eczema, Type 2 Diabetes
- What is being tested?
- Hyperinsulinemic euglycemic clamp
- How many people
- 32 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2015to Dec 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with atopic dermatitis are recruited from Department of Dermatology and Allergology at Gentofte Hospital. Control subjects are recruited from the Danish recruitment site "www.forsoegsperson.dk".
Who may be able to join
- Moderate to severe atopic dermatitis for at least 5 years
- BMI < 30 kg/m2
- HbA1c < 42 mmol/mol
Who cannot join
- Diabetes
- Prediabetes
- First-degree relatives with diabetes
- Chronic inflammatory diseases other than atopic dermatitis and asthma
- Pregnancy
- Breast-feeding
- Daily intake of medications that are known to influence the glucose metabolism are not allowed one month before the study (e.g. asthma medicines and hormonal contraception).
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Center for Diabetes Research, Gentofte Hospital, University of Copenhagen
Hellerup, 2900
About this study
The incidence of atopic dermatitis and type 2 diabetes, respectively, has increased over many years. Novel research shows an association between the two conditions. While this relationship at least in theory can be explained by lifestyle factors, there is reason to believe that other pathophysiological mechanisms are involved. Hence, our hypothesis is that patients with atopic dermatitis are insulin resistant due to their chronic inflammatory state. Insulin resistance might play an unknown part in the increased frequency of type 2 diabetes among patients with atopic dermatitis. In the present project, the investigators aim to measure insulin sensitivity by means of the 'golden standard' hyperinsulinaemic euglycaemic clamp in patients suffering from atopic dermatitis compared to a healthy control group (matched case-control study). The project is a close collaboration between The Department of Dermatology and Allergy and Center for Diabetes Research at Gentofte Hospital.
- Conditions
- Atopic Dermatitis/Eczema, Type 2 Diabetes
- Being tested
- Hyperinsulinemic euglycemic clamp
- Medical subject headings
- Dermatitis, Atopic, Eczema, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperinsulinemic euglycemic clampDiagnostic test
Hyperinsulinemic euglycemic clamp to detect insulin sensitivity
| Study group | Role | What they receive |
|---|---|---|
| Control group | Healthy control subjects Receives: Diagnostic Test: Hyperinsulinemic euglycemic clamp | |
| Atopic dermatitis/eczema group | Patients with atopic dermatitis Receives: Diagnostic Test: Hyperinsulinemic euglycemic clamp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Sensitivity Difference Between Patients With Atopic Dermatitis and Controls
The outcome is determined by measuring the glucose necessary to maintain euglycaemia during increased insulin levels generated by continuous insulin infusion (measured as the M-value: the rate of glucose infused is equal to the rate of whole-body glucose disposal or metabolizable glucose (M) and reflects the amount of exogenous glucose necessary to fully compensate for the hyperinsulinemia)
Measured: Baseline, plasma glucose every 5 minutes, insulin/C-peptide, glucagon every 10-15 minutes throughout a 3 hour hyperinsulinaemic euglycaemic clamp
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2016 (estimated)
- Study startNov 2015
- Primary completionSep 2016
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atopic Dermatitis/EczemaStudies 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
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filip Krag Knop, University Hospital, Gentofte, Copenhagen
- Investigators
- Filip K Knop, MD, PhD, Study director, University Hospital, GentofteJacob P Thyssen, MD,PhD,DMSc, Study director, University Hospital, Gentofte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03003793
- Sponsor's protocol ID
- H-15010198
- Acronym
- AD-IF
- Status last verified
- Sep 2019
- First submitted
- 1 Mar 2016
- Last updated
- 18 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin Sensitivity in Patients With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT03003793
- Acronym / sponsor ID
- AD-IF / H-15010198
- Conditions
- Atopic Dermatitis/Eczema, Type 2 Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 28 Dec 2016 (estimated)
- Results
- Posted 18 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The incidence of atopic dermatitis and type 2 diabetes, respectively, has increased over many years. Novel research shows an association between the two conditions. While this relationship at least in theory can be explained by lifestyle factors, there is reason to believe that other pathophysiological mechanisms are involved. Hence, our hypothesis is that patients with atopic dermatitis are insulin resistant due to their chronic inflammatory state. Insulin resistance might play an unknown part in the increased frequency of type 2 diabetes among patients with atopic dermatitis. In the present project, the investigators aim to measure insulin sensitivity by means of the 'golden standard' hyperinsulinaemic euglycaemic clamp in patients suffering from atopic dermatitis compared to a healthy control group (matched case-control study). The project is a close collaboration between The Department of Dermatology and Allergy and Center for Diabetes Research at Gentofte Hospital.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Diagnostic Test: Hyperinsulinemic euglycemic clampHealthy control subjects |
| Atopic dermatitis/eczema group | – | Diagnostic Test: Hyperinsulinemic euglycemic clampPatients with atopic dermatitis |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with atopic dermatitis are recruited from Department of Dermatology and Allergology at Gentofte Hospital. Control subjects are recruited from the Danish recruitment site "www.forsoegsperson.dk".
Key inclusion criteria (3 listed)
- Moderate to severe atopic dermatitis for at least 5 years
- BMI < 30 kg/m2
- HbA1c < 42 mmol/mol
Key exclusion criteria (7 listed)
- Diabetes
- Prediabetes
- First-degree relatives with diabetes
- Chronic inflammatory diseases other than atopic dermatitis and asthma
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperinsulinemic euglycemic clampHyperinsulinemic euglycemic clamp to detect insulin sensitivity | Diagnostic test | Atopic dermatitis/eczema group, Control group |
Primary outcome
Insulin Sensitivity Difference Between Patients With Atopic Dermatitis and Controls
Time frame: Baseline, plasma glucose every 5 minutes, insulin/C-peptide, glucagon every 10-15 minutes throughout a 3 hour hyperinsulinaemic euglycaemic clamp
The outcome is determined by measuring the glucose necessary to maintain euglycaemia during increased insulin levels generated by continuous insulin infusion (measured as the M-value: the rate of glucose infused is equal to the rate of whole-body glucose disposal or metabolizable glucose (M) and reflects the amount of exogenous glucose necessary to fully compensate for the hyperinsulinemia)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
Related trials for Atopic Dermatitis/Eczema
RecruitingPhase 2
PRA-216 Atopic Dermatitis Safety and Efficacy Study
Atopic Dermatitis (AD)
RecruitingPhase 1
Phase 1a/1b Study of TRB-061 in Healthy Participants & Patients With Atopic Dermatitis
Moderate-to-severe Atopic Dermatitis
RecruitingObservational study
Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
Acne, Atopic Dermatitis
RecruitingPhase 1
Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopic Dermatitis
Hyper IgE Syndrome From STAT3 Mutation, Job s Syndrome
RecruitingPhase 2
A Study Evaluating TRIV-573 in Atopic Dermatitis
Atopic Dermatitis
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.
Filip K Knop, MD, PhD study director
University Hospital, Gentofte
Jacob P Thyssen, MD,PhD,DMSc study director
University Hospital, Gentofte
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis/Eczema and Type 2 Diabetes, run by University Hospital, Gentofte, Copenhagen at 1 site 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 3 inclusion and 7 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 18 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 18 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Insulin Sensitivity Difference Between Patients With Atopic Dermatitis and Controls (time frame: Baseline, plasma glucose every 5 minutes, insulin/C-peptide, glucagon every 10-15 minutes throughout a 3 hour hyperinsulinaemic euglycaemic clamp). 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 18 Oct 2019.