Insulin Sensitivity in Patients With Atopic Dermatitis

Type 2 Diabetes Clinical Trial

— AD-IF  

Official title:

Insulin Sensitivity in Patients With Atopic Dermatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03003793
• Other study ID #: H-15010198
• Status: Completed
• Start date: November 2015
• Est. completion date: December 2017

Study information

• Verified date: September 2019
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Atopic Dermatitis/Eczema
• Dermatitis
• Dermatitis, Atopic
• Eczema
• Insulin Resistance
• Type 2 Diabetes

Intervention

Diagnostic Test:
• Hyperinsulinemic euglycemic clamp
Hyperinsulinemic euglycemic clamp to detect insulin sensitivity

Locations

Country	Name	City	State
Denmark	Center for Diabetes Research, Gentofte Hospital, University of Copenhagen	Hellerup

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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)	Baseline, plasma glucose every 5 minutes, insulin/C-peptide, glucagon every 10-15 minutes throughout a 3 hour hyperinsulinaemic euglycaemic clamp