Insulin Sensitivity in Patients With Atopic Dermatitis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Atopic Dermatitis/Eczema Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Diabetes Mellitus Diabetes Mellitus, Type 2 Eczema Endocrine System Diseases Genetic Diseases, Inborn Glucose Metabolism Disorders Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases Type 2 Diabetes

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Center for Diabetes Research, Gentofte Hospital, University of Copenhagen

Hellerup, 2900, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Hyperinsulinemic euglycemic clamp

Diagnostic Test

Hyperinsulinemic euglycemic clamp to detect insulin sensitivity

Primary outcomes

Insulin Sensitivity Difference Between Patients With Atopic Dermatitis and Controls

Time frame: 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)

Sponsors and collaborators

Lead sponsor

University Hospital, Gentofte, Copenhagen

Other

Registry information

Acronym: AD-IF

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2017
First posted: Dec 28, 2016
Registry last updated: Oct 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed