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All trials for Atopic Dermatitis/Eczema All trials for Type 2 Diabetes All trials of Hyperinsulinemic euglycemic clamp
-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 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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Control group | | Diagnostic Test: Hyperinsulinemic euglycemic clamp | Healthy control subjects |
| Atopic dermatitis/eczema group | | Diagnostic Test: Hyperinsulinemic euglycemic clamp | Patients with atopic dermatitis |
- Hyperinsulinemic euglycemic clamp (Diagnostic test): Hyperinsulinemic euglycemic clamp to detect insulin sensitivity
+Outcome measures
Primary outcomes
- Insulin Sensitivity Difference Between Patients With Atopic Dermatitis and Controls [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)
+Eligibility
Sex: All, ages: 18 Years to 75 Years, accepts healthy volunteers
Inclusion Criteria:
* Moderate to severe atopic dermatitis for at least 5 years
* BMI < 30 kg/m2
* HbA1c < 42 mmol/mol
Exclusion Criteria:
* 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).
+Posted results
Participant flow
| Milestone | Control Group | Atopic Dermatitis/Eczema Group |
|---|
| Started | 16 | 16 |
| Completed | 16 | 16 |
| Not completed | 0 | 0 |
Outcome results
- Insulin Sensitivity Difference Between Patients With Atopic Dermatitis and Controls (Primary), Mean, mg glucose/kg body mass/minute: Control Group 9.8 +/- 0.8; Atopic Dermatitis/Eczema Group 9.2 +/- 0.6
Adverse events
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|
| Control Group | 0 | 0/16 (0.0%) | 0/16 (0.0%) |
| Atopic Dermatitis/Eczema Group | 0 | 0/16 (0.0%) | 0/16 (0.0%) |
+Locations (1)
| Facility | City | Country | Status |
|---|
| Center for Diabetes Research, Gentofte Hospital, University of Copenhagen | Hellerup | Denmark | |
+Investigators
- Filip K Knop, MD, PhD, Study director, University Hospital, Gentofte
- Jacob P Thyssen, MD,PhD,DMSc, Study director, University Hospital, Gentofte