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Clinical Trials/NCT03003793
NCT03003793
Completed
Not Applicable

Insulin Sensitivity in Patients With Atopic Dermatitis

University Hospital, Gentofte, Copenhagen1 site in 1 country32 target enrollmentNovember 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Atopic Dermatitis/Eczema
Sponsor
University Hospital, Gentofte, Copenhagen
Enrollment
32
Locations
1
Primary Endpoint
Insulin Sensitivity Difference Between Patients With Atopic Dermatitis and Controls
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2015
End Date
December 2017
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Gentofte, Copenhagen
Responsible Party
Principal Investigator
Principal Investigator

Filip Krag Knop

MD PhD

University Hospital, Gentofte, Copenhagen

Eligibility Criteria

Inclusion Criteria

  • Moderate to severe atopic dermatitis for at least 5 years
  • BMI \< 30 kg/m2
  • HbA1c \< 42 mmol/mol

Exclusion Criteria

  • 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).

Outcomes

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)

Study Sites (1)

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