Atopic Dermatitis Clinical Trial
Official title:
IL-4 & Insulin Resistance in Patients With Atopic Dermatitis
Verified date | February 2024 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic Arizona | Scottsdale | Arizona |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
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 |
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