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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Healthy control subjects |
| |
| Atopic dermatitis/eczema group | Patients with atopic dermatitis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperinsulinemic euglycemic clamp | Diagnostic Test | Hyperinsulinemic euglycemic clamp to detect insulin sensitivity |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline, plasma glucose every 5 minutes, insulin/C-peptide, glucagon every 10-15 minutes throughout a 3 hour hyperinsulinaemic euglycaemic clamp |
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Inclusion Criteria:
Exclusion Criteria:
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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".
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| Name | Affiliation | Role |
|---|---|---|
| Filip K Knop, MD, PhD | University Hospital, Gentofte | Study Director |
| Jacob P Thyssen, MD,PhD,DMSc | University Hospital, Gentofte | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Diabetes Research, Gentofte Hospital, University of Copenhagen | Hellerup | 2900 | Denmark |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | Healthy control subjects Hyperinsulinemic euglycemic clamp |
| FG001 | Atopic Dermatitis/Eczema Group | Patients with atopic dermatitis Hyperinsulinemic euglycemic clamp |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | Healthy control subjects Hyperinsulinemic euglycemic clamp |
| BG001 | Atopic Dermatitis/Eczema Group | Patients with atopic dermatitis Hyperinsulinemic euglycemic clamp |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Posted | Mean | Standard Deviation | mg glucose/kg body mass/minute | Baseline, plasma glucose every 5 minutes, insulin/C-peptide, glucagon every 10-15 minutes throughout a 3 hour hyperinsulinaemic euglycaemic clamp |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group | Healthy control subjects Hyperinsulinemic euglycemic clamp |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lise Gether, MD | Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen | lise.gether.01@regionh.dk |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D004485 | Eczema |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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Whole blood.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Atopic dermatitis duration | Mean | Standard Deviation | years |
|
| Body master index | Mean | Standard Deviation | kg/m^2 |
|
Patients with atopic dermatitis Hyperinsulinemic euglycemic clamp |
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Atopic Dermatitis/Eczema Group | Patients with atopic dermatitis Hyperinsulinemic euglycemic clamp | 0 | 16 | 0 | 16 |
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| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |