An observational study in Atopic Dermatitis/Eczema and Type 2 Diabetes, sponsored by University Hospital, Gentofte, Copenhagen. Completed at 1 site in Denmark. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-18.
Sponsored by University Hospital, Gentofte, Copenhagen · Observational
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.
1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.
This study's enrollment of 32 is below the median of 150 across 237 observational studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →University Hospital, Gentofte, Copenhagen is the lead sponsor of 154 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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".
Exclusion Criteria:
Healthy control subjects
Diagnostic Test: Hyperinsulinemic euglycemic clamp
Patients with atopic dermatitis
Diagnostic Test: Hyperinsulinemic euglycemic clamp
Hyperinsulinemic euglycemic clamp to detect insulin sensitivity
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)
Time frame: Baseline, plasma glucose every 5 minutes, insulin/C-peptide, glucagon every 10-15 minutes throughout a 3 hour hyperinsulinaemic euglycaemic clamp
| Milestone | Control Group | Atopic Dermatitis/Eczema Group |
|---|---|---|
| Started | 16 | 16 |
| Completed | 16 | 16 |
| Not completed | 0 | 0 |
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)
| mg glucose/kg body mass/minute | Control Group | Atopic Dermatitis/Eczema Group |
|---|---|---|
| Insulin Sensitivity Difference Between Patients With Atopic Dermatitis and Controls | 9.8 ± 0.8 | 9.2 ± 0.6 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control Group | — | 0/16 (0%) | 0/16 (0%) |
| Atopic Dermatitis/Eczema Group | — | 0/16 (0%) | 0/16 (0%) |
| Age, Categorical(Participants) | Control Group | Atopic Dermatitis/Eczema Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 16 | 16 | 32 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Control Group | Atopic Dermatitis/Eczema Group | Total |
|---|---|---|---|
| Mean | 33 ± 3 | 33 ± 3 | 33 ± 3 |
| Sex: Female, Male(Participants) | Control Group | Atopic Dermatitis/Eczema Group | Total |
|---|---|---|---|
| Female | 9 | 9 | 18 |
| Male | 7 | 7 | 14 |
| Region of Enrollment(participants) | Control Group | Atopic Dermatitis/Eczema Group | Total |
|---|---|---|---|
| Denmark | 16 | 16 | 32 |
| Atopic dermatitis duration(years) | Control Group | Atopic Dermatitis/Eczema Group | Total |
|---|---|---|---|
| Mean | NA ± NA | 28 ± 3 | NA ± NA |
| Body master index(kg/m^2) | Control Group | Atopic Dermatitis/Eczema Group | Total |
|---|---|---|---|
| Mean | 24.4 ± 1 | 24.5 ± 1 | 24.5 ± 1 |
Plan to share: Undecided
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This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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University Hospital, Gentofte, Copenhagen