Insulin Sensitivity in Patients With Atopic Dermatitis

NCT03003793 | Completed Results

• 1 other identifier: H-15010198
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Insulin Sensitivity Difference Between Patients With Atopic Dermatitis and Controls

  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

Study Arms (2)

Control group

Healthy control subjects

Diagnostic Test: Hyperinsulinemic euglycemic clamp

Atopic dermatitis/eczema group

Patients with atopic dermatitis

Diagnostic Test: Hyperinsulinemic euglycemic clamp

Interventions

Hyperinsulinemic euglycemic clamp DIAGNOSTIC_TEST

Hyperinsulinemic euglycemic clamp to detect insulin sensitivity

Atopic dermatitis/eczema group; Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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".

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Hospital, Gentofte, Copenhagen: lead

Study Sites (1)

Center for Diabetes Research, Gentofte Hospital, University of Copenhagen

Hellerup, 2900, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood.

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Lise Gether, MD
• Organization: Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen

lise.gether.01@regionh.dk

Study Officials

• Filip K Knop, MD, PhD

  University Hospital, Gentofte

  STUDY DIRECTOR

• Jacob P Thyssen, MD,PhD,DMSc

  University Hospital, Gentofte

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: March 1, 2016
• First Posted: December 28, 2016
• Study Start: November 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: December 1, 2017
• Last Updated: October 18, 2019
• Results First Posted: October 18, 2019

Record last verified: 2019-09

Locations

DK (1)