IL-4 & Insulin Resistance in Patients With Atopic Dermatitis
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Homa IR
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability to sign informed consent form.
- •Body mass index (BMI), 22-29 kg/m^
- •Diagnosis of Atopic Dermatitis treated with dupilumab for longer than 6 months.
- •Diagnosis of Atopic Dermatitis treated with topical steroids or phototherapy.
排除标准
- •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.
研究组 & 干预措施
Subjects on Dupilumab
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"
干预措施: Dupilumab (Drug)
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"
干预措施: Photo therapy (Other)
结局指标
主要结局
Homa IR
时间窗: 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).
Matsuda Index
时间窗: baseline
The Matsuda index is able to estimate peripheral insulin sensitivity by computing the product of glucose and insulin collected during the OGTT.
次要结局
- Adipo-IR(baseline)
- Systemic inflammatory markers(baseline)
- Adipokines(baseline)
- Fasting Free Fatty Acid(baseline)
研究者
Elena Anna (Eleanna) De Filippis, M.D., Ph.D.
Principal Investigator
Mayo Clinic