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Completed

NCT Number: NCT05372003

IL-4 and Insulin Resistance for Treatment of 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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Mayo Clinic Arizona

Scottsdale, Arizona, 85259, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dupilumab

Drug

dupilumab injections will be prescribed and managed by dermatology as standard of care

Photo therapy

Other

light therapy will be prescribed and managed by dermatology as standard of care

Other names: light therapy

Primary outcomes

  1. Homa IR

    Time frame: baseline

    Homeostatic Model Assessment of Insulin Resistance will be calculated by multiplying the fasting glucose concentration (mg/dl) by the fasting insulin concentration (mmol/L).

  2. Matsuda Index

    Time frame: baseline

    The Matsuda index is able to estimate peripheral insulin sensitivity by computing the product of glucose and insulin collected during the OGTT.

Secondary outcomes

  1. Adipo-IR

    Time frame: baseline

    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

  2. Systemic inflammatory markers

    Time frame: baseline

    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)

  3. Adipokines

    Time frame: baseline

    We will measure the plasma levels of adipokines (leptin and adiponectin) by radioimmunoassay and ELISA in all subjects recruited and compared across study group

  4. Fasting Free Fatty Acid

    Time frame: baseline

    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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

IL-4 & Insulin Resistance in Patients With Atopic Dermatitis

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 12, 2022
Registry last updated
Feb 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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