IL-4 and Insulin Resistance for Treatment of Patients With Atopic Dermatitis

IL-4 & Insulin Resistance in Patients With Atopic Dermatitis

The purpose of this study is to better understand the interactions between the innate immune system, in particular eosinophils, their secreted cytokines (interleukin-4), and metabolism in human health and disease states such as obesity and insulin resistance.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Dupilumab; Other: Photo therapy

Detailed Description

Patients with a body mass index (BMI) less than 30 kg/m2 and a history of atopic dermatitis on long-term (greater than 6 months) treatment with dupilumab. Researchers will compare in vivo evaluations of insulin sensitivity in subjects on dupilumab vs subjects matched for similar weight and BMI, with atopic dermatitis, but without dupilumab therapy (phototherapy).

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic Arizona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Ability to sign informed consent form.
• Body mass index (BMI), 22-29 kg/m^2.
• Diagnosis of Atopic Dermatitis treated with dupilumab for longer than 6 months.
• Diagnosis of Atopic Dermatitis treated with topical steroids or phototherapy.

Exclusion Criteria:

• Any prescription for systemic glucocorticoid, immunosuppressant, antidiabetic medications in the past 6 months.
• Evidence of diabetes mellitus.
• Morning Cortisol < 5 mg/dl (collected before 10.30 am).
• Presence of acute illness.
• Low hemoglobin or hematocrit.
• Current participation in a weight-loss regimen, with a weight loss > 10% total body weight in the last 6 months).
• Smoking history in the last 6 months (tobacco, nicotine-containing products including e-cigarettes).
• Pregnant or breastfeeding.
• Personal history of gastric bypass surgery.
• Previous participation in a clinical trial with an investigational product in the past 30 days, or 5 half-lives, or twice the duration of the biological effect of the investigational drug (whichever is longest).
• Exposed to more than 4 new chemical entities within 12 months before study enrollment.
• Any other condition or event considered exclusionary by the PI and the study physician.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Subjects on Dupilumab; individuals with atopic dermatitis placed on dupilumab for more than 6 months will be eligible to this study. Their metabolic profile will be compared to the group of "Subjects on Phototherapy"	Drug: Dupilumab; dupilumab injections will be prescribed and managed by dermatology as standard of care
Active Comparator: Subjects on Phototherapy; individuals with atopic dermatitis placed on phototherapy for more than 6 months will be eligible to this study to serve as an active comparator to the "Subjects with Dupilumab"	Other: Photo therapy; light therapy will be prescribed and managed by dermatology as standard of care; Other Names: light therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Homa IR	Homeostatic Model Assessment of Insulin Resistance will be calculated by multiplying the fasting glucose concentration (mg/dl) by the fasting insulin concentration (mmol/L).	baseline
Matsuda Index	The Matsuda index is able to estimate peripheral insulin sensitivity by computing the product of glucose and insulin collected during the OGTT.	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adipo-IR	Adipo-IR will be calculated by multiplying the fasting FFA concentration (mmol/L) by the fasting insulin concentration (pmol/L) obtained during the baseline blood collection during the oral glucose tolerance test	baseline
Systemic inflammatory markers	Circulating plasma levels of inflammatory markers interleukin 1 (IL1), Tumor necrosis factor alpha (TNFa), highly sensitive C-reactive protein (hs-CRP), Monocyte Chemoattractant Protein 1 (MCP1), interleukin 6 (IL-6), Interleukin 4 (IL-4) and interleukin 13 (IL13)	baseline
Adipokines	We will measure the plasma levels of adipokines (leptin and adiponectin) by radioimmunoassay and ELISA in all subjects recruited and compared across study group	baseline
Fasting Free Fatty Acid	During the OGTT, we will collect fasting blood to assess levels of plasma free fatty acid (mmol/L). These values will be compared across the 2 different group studied.	baseline

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Elena Anna De Filippis, MD, PhD, Mayo

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2022
• Primary Completion (Actual): February 23, 2024
• Study Completion (Actual): February 23, 2024

Study Registration Dates

• First Submitted: April 29, 2022
• First Submitted That Met QC Criteria: May 10, 2022
• First Posted (Actual): May 12, 2022

Study Record Updates

• Last Update Posted (Estimated): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hyperinsulinism; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Insulin Resistance; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: 22-002567

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No