Impact of the Severity of Pediatric Psoriasis on Childhood Body Mass Index and Comorbid Risk Factors: an Epidemiologic Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 409
- 试验地点
- 14
- 主要终点
- BMI
研究概览
简要总结
The object of this research study is to examine these associations in children as very little is known about psoriasis and cardiovascular risk factors in the pediatric population.
详细描述
Several environmental factors and comorbid conditions have been found to be associated with psoriasis in adults, including obesity, depression, smoking, and other cardiovascular risk factors such as high blood pressure. The object of this research study is to examine these associations in children as very little is known about psoriasis and cardiovascular risk factors in the pediatric population.
This is a multi-center study with a planned total enrollment of about 200 subjects ages 2-17 years old with psoriasis and 100 aged-match controls. Patient and family history will be recorded. All subjects will undergo standard height, weight, blood pressure, and waist circumference (WC). For the obese and overweight subjects we will also obtain their growth charts to attempt to correlate weight gain with psoriasis onset and progression. All data will be compiled and then statistically analyzed.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must be between the ages of 5 and 17 years at the time of enrollment.
- •Subjects of either sex.
- •Subjects who have had psoriatic plaques for more than 6 months.
- •Subjects and guardians of minors must sign the approved IRB consent form(s) prior to initiation of the study protocol.
- •Subjects enrolled as "non-inflammatory" normal controls will carry a common non- systemic skin condition, such as acne, nevi, warts and molluscum as their main diagnosis.
- •Subjects enrolled as "inflammatory" normal controls will carry a diagnosis of moderate to severe atopic dermatitis.
排除标准
- •Subjects who are unable to give informed consent or assent.
- •Subjects who have had psoriasis for less than 6 months.
- •Subjects whose condition is deemed unsafe or incapable by the study investigator for study participation.
结局指标
主要结局
BMI
时间窗: 07/2010
次要结局
- Waist circumference(07/2010)
- Blood Pressure(07/2010)
研究者
Amy Paller
Chair, Department of Dermatology, Professor of Dermatology and Pediatric Dermatology
Northwestern University