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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05372003
Other study ID # 22-002567
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
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
Health authority
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.

Study Design


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
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