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

Atopic Dermatitis Clinical Trial

Official title:

IL-4 & Insulin Resistance in Patients With Atopic Dermatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05372003
• Other study ID #: 22-002567
• Status: Completed
• Phase: Early Phase 1
• Start date: August 9, 2022
• Est. completion date: February 23, 2024

Study information

• Verified date: February 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: February 23, 2024
• Est. primary completion date: February 23, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema
• Insulin Resistance

Intervention

Drug:
• Dupilumab
dupilumab injections will be prescribed and managed by dermatology as standard of care

Other:
• Photo therapy
light therapy will be prescribed and managed by dermatology as standard of care

Locations

Country	Name	City	State
United States	Mayo Clinic Arizona	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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