Insulin Sensitivity in Patients With Atopic Dermatitis

NCT ID: NCT03003793

Last Updated: 2019-10-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 32 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2017-12-31

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.

Conditions

Atopic Dermatitis/Eczema; Type 2 Diabetes

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Control group

Healthy control subjects

Hyperinsulinemic euglycemic clamp

Intervention Type: DIAGNOSTIC_TEST

Hyperinsulinemic euglycemic clamp to detect insulin sensitivity

Atopic dermatitis/eczema group

Patients with atopic dermatitis

Hyperinsulinemic euglycemic clamp

Intervention Type: DIAGNOSTIC_TEST

Hyperinsulinemic euglycemic clamp to detect insulin sensitivity

Interventions

Hyperinsulinemic euglycemic clamp

Hyperinsulinemic euglycemic clamp to detect insulin sensitivity

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Filip Krag Knop

MD PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Filip K Knop, MD, PhD

Role: STUDY_DIRECTOR

University Hospital, Gentofte

Jacob P Thyssen, MD,PhD,DMSc

Role: STUDY_DIRECTOR

University Hospital, Gentofte

Locations

Center for Diabetes Research, Gentofte Hospital, University of Copenhagen

Hellerup, , Denmark

Countries

Denmark

Other Identifiers

H-15010198

Identifier Type: -

Identifier Source: org_study_id