Insulin Sensitivity in Patients With Atopic Dermatitis (AD-IF)

September 25, 2019 updated by: Filip Krag Knop, University Hospital, Gentofte, Copenhagen
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hellerup, Denmark, 2900
        • Center for Diabetes Research, Gentofte Hospital, University of Copenhagen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with atopic dermatitis are recruited from Department of Dermatology and Allergology at Gentofte Hospital.

Control subjects are recruited from the Danish recruitment site "www.forsoegsperson.dk".

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control group
Healthy control subjects
Diagnostic test: Hyperinsulinemic euglycemic clamp
Hyperinsulinemic euglycemic clamp to detect insulin sensitivity
Atopic dermatitis/eczema group
Patients with atopic dermatitis
Diagnostic test: Hyperinsulinemic euglycemic clamp
Hyperinsulinemic euglycemic clamp to detect insulin sensitivity

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Gentofte, Copenhagen

Investigators

  • Study Director: Filip K Knop, MD, PhD, University Hospital, Gentofte
  • Study Director: Jacob P Thyssen, MD,PhD,DMSc, University Hospital, Gentofte

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2015

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

March 1, 2016

First Submitted That Met QC Criteria

December 27, 2016

First Posted (Estimate)

December 28, 2016

Study Record Updates

Last Update Posted (Actual)

October 18, 2019

Last Update Submitted That Met QC Criteria

September 25, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-15010198

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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