Insulin Sensitivity in Patients With Atopic Dermatitis

Completed

• Conditions: Atopic Dermatitis/Eczema; Type 2 Diabetes
• Interventions: Diagnostic Test: Hyperinsulinemic euglycemic clamp

• Registration Number: NCT03003793
• Lead Sponsor: University Hospital, Gentofte, Copenhagen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2016-03-01
• Primary Completion: 2016-09
• Study First Submitted QC: 2016-12-27
• Study First Posted: 2016-12-28
• Study Completion: 2017-12
• Results First Submitted: 2019-06-19
• Status Verified: 2019-09
• Results First Submitted QC: 2019-09-25
• Last Update Submitted: 2019-09-25
• Results First Posted: 2019-10-18
• Last Update Posted: 2019-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control group	Hyperinsulinemic euglycemic clamp	Healthy control subjects
Atopic dermatitis/eczema group	Hyperinsulinemic euglycemic clamp	Patients with atopic dermatitis

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Center for Diabetes Research, Gentofte Hospital, University of Copenhagen; 🇩🇰 Hellerup, Denmark