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

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ClinicalTrials.gov Identifier: NCT03003793
Recruitment Status : Active, not recruiting
First Posted : December 28, 2016
Last Update Posted : September 6, 2017
Sponsor:
Information provided by (Responsible Party):
Filip Krag Knop, University Hospital, Gentofte, Copenhagen

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.

Condition or disease
Atopic Dermatitis/Eczema Type 2 Diabetes

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Study Type : Observational
Actual Enrollment : 32 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Insulin Sensitivity in Patients With Atopic Dermatitis
Study Start Date : November 2015
Actual Primary Completion Date : September 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Eczema
Drug Information available for: Insulin

Group/Cohort
Control group
Healthy control subjects Hyperinsulinemic euglycemic clamp
Atopic dermatitis/eczema group
Patients with atopic dermatitis Hyperinsulinemic euglycemic clamp



Primary Outcome Measures :
  1. M-value difference between patients with atopic dermatitis and controls [ Time Frame: 1 year ]
    The outcome is determined by measuring the glucose necessary to maintain euglycaemia during increased insulin levels generated by continuous insulin infusion (M-value).


Biospecimen Retention:   Samples With DNA
Whole blood.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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".

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03003793


Locations
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Denmark
Center for Diabetes Research, Gentofte Hospital, University of Copenhagen
Hellerup, Denmark, 2900
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
Investigators
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Study Director: Filip K Knop, MD, PhD University Hospital, Gentofte
Study Director: Jacob P Thyssen, MD,PhD,DMSc University Hospital, Gentofte

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Responsible Party: Filip Krag Knop, MD PhD, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier: NCT03003793     History of Changes
Other Study ID Numbers: H-15010198
First Posted: December 28, 2016    Key Record Dates
Last Update Posted: September 6, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Eczema
Dermatitis
Dermatitis, Atopic
Insulin Resistance
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs