NCT05372003

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 12, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

August 9, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2024

Completed
Last Updated

February 26, 2024

Status Verified

February 1, 2024

Enrollment Period

1.5 years

First QC Date

April 29, 2022

Last Update Submit

February 22, 2024

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (4)

  • Adipo-IR

    baseline

  • Systemic inflammatory markers

    baseline

  • Adipokines

    baseline

  • Fasting Free Fatty Acid

    baseline

Study Arms (2)

Subjects on Dupilumab

EXPERIMENTAL

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"

Drug: Dupilumab

Subjects on Phototherapy

ACTIVE COMPARATOR

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"

Other: Photo therapy

Interventions

DupilumabDRUG

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

Subjects on Dupilumab
Photo therapyOTHER

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

Also known as: light therapy
Subjects on Phototherapy

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic Arizona

Scottsdale, Arizona, 85259, United States

Location

Related Links

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

dupilumabPhototherapy

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Elena Anna De Filippis, MD, PhD

    Mayo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 29, 2022

First Posted

May 12, 2022

Study Start

August 9, 2022

Primary Completion

February 23, 2024

Study Completion

February 23, 2024

Last Updated

February 26, 2024

Record last verified: 2024-02

Locations

US(1)