Atopic Dermatitis/Eczema, Type 2 Diabetes
Conditions
Brief 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.
Interventions
DIAGNOSTIC_TESTHyperinsulinemic euglycemic clamp
Hyperinsulinemic euglycemic clamp to detect insulin sensitivity
Sponsors
University Hospital, Gentofte, Copenhagen
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Denmark
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Group Healthy control subjects Hyperinsulinemic euglycemic clamp | 16 |
| Atopic Dermatitis/Eczema Group Patients with atopic dermatitis Hyperinsulinemic euglycemic clamp | 16 |
| Total | 32 |
Baseline characteristics
| Characteristic | Control Group | Atopic Dermatitis/Eczema Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 16 Participants | 32 Participants |
| Age, Continuous | 33 years STANDARD_DEVIATION 3 | 33 years STANDARD_DEVIATION 3 | 33 years STANDARD_DEVIATION 3 |
| Atopic dermatitis duration | NA years | 28 years STANDARD_DEVIATION 3 | NA years |
| Body master index | 24.4 kg/m^2 STANDARD_DEVIATION 1 | 24.5 kg/m^2 STANDARD_DEVIATION 1 | 24.5 kg/m^2 STANDARD_DEVIATION 1 |
| Region of Enrollment Denmark | 16 participants | 16 participants | 32 participants |
| Sex: Female, Male Female | 9 Participants | 9 Participants | 18 Participants |
| Sex: Female, Male Male | 7 Participants | 7 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 16 | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 |
Outcome results
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)
Time frame: Baseline, plasma glucose every 5 minutes, insulin/C-peptide, glucagon every 10-15 minutes throughout a 3 hour hyperinsulinaemic euglycaemic clamp
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Insulin Sensitivity Difference Between Patients With Atopic Dermatitis and Controls | 9.8 mg glucose/kg body mass/minute | Standard Deviation 0.8 |
| Atopic Dermatitis/Eczema Group | Insulin Sensitivity Difference Between Patients With Atopic Dermatitis and Controls | 9.2 mg glucose/kg body mass/minute | Standard Deviation 0.6 |