Back to resultsIL-4 and Insulin Resistance for Treatment of Patients With Atopic Dermatitis
Primary Purpose
Atopic Dermatitis
Status
Suspended
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Dupilumab
Photo therapy
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis
Eligibility Criteria
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.
Sites / Locations
- Mayo Clinic Arizona
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Subjects on Dupilumab
Subjects on Phototherapy
Arm Description
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"
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"
Outcomes
Primary Outcome Measures
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).
Matsuda Index
The Matsuda index is able to estimate peripheral insulin sensitivity by computing the product of glucose and insulin collected during the OGTT.
Secondary Outcome Measures
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
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)
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05372003
Brief Title
IL-4 and Insulin Resistance for Treatment of Patients With Atopic Dermatitis
Official Title
IL-4 & Insulin Resistance in Patients With Atopic Dermatitis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Suspended
Why Stopped
lack of funding renewal
Study Start Date
August 9, 2022 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Subjects on Dupilumab
Arm Type
Experimental
Arm Description
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"
Arm Title
Subjects on Phototherapy
Arm Type
Active Comparator
Arm Description
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"
Intervention Type
Drug
Intervention Name(s)
Dupilumab
Intervention Description
dupilumab injections will be prescribed and managed by dermatology as standard of care
Intervention Type
Other
Intervention Name(s)
Photo therapy
Other Intervention Name(s)
light therapy
Intervention Description
light therapy will be prescribed and managed by dermatology as standard of care
Primary Outcome Measure Information:
Title
Homa IR
Description
Homeostatic Model Assessment of Insulin Resistance will be calculated by multiplying the fasting glucose concentration (mg/dl) by the fasting insulin concentration (mmol/L).
Time Frame
baseline
Title
Matsuda Index
Description
The Matsuda index is able to estimate peripheral insulin sensitivity by computing the product of glucose and insulin collected during the OGTT.
Time Frame
baseline
Secondary Outcome Measure Information:
Title
Adipo-IR
Description
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
Time Frame
baseline
Title
Systemic inflammatory markers
Description
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)
Time Frame
baseline
Title
Adipokines
Description
We will measure the plasma levels of adipokines (leptin and adiponectin) by radioimmunoassay and ELISA in all subjects recruited and compared across study group
Time Frame
baseline
Title
Fasting Free Fatty Acid
Description
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.
Time Frame
baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elena Anna De Filippis, MD, PhD
Organizational Affiliation
Mayo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
IL-4 and Insulin Resistance for Treatment of Patients With Atopic Dermatitis
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