Assessor-Blinded Study of the Metabolic Syndrome and Surrogate Markers of Increased Cardiovascular Risk in Children With Moderate to Severe Psoriasis Compared With Age Matched Population of Children With Warts
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- The primary objective of this study is to determine if children with psoriasis will have an increased prevalence of the metabolic syndrome.
研究概览
简要总结
The objective of this study is to assess whether there is an increased risk of the metabolic syndrome in children with psoriasis compared to children without psoriasis.
详细描述
Adult patients with psoriasis, especially those who are young and with severe disease, have an increased prevalence of myocardial infarction and metabolic syndrome, and increased mortality. Tumor Necrosis Factor (TNF) and other inflammatory cytokines are felt to play an important role not only in the pathogenesis of psoriasis and psoriatic arthritis, but in the pathogenesis of the metabolic syndrome and increased cardiovascular mortality and morbidity.
However, the prevalence of metabolic syndrome and surrogate markers of increased cardiovascular risk, such as lower flow-mediated dilation (FMD) during reactive hyperemia, measured by high-resolution brachial artery ultrasound, lower hyperemia-induced, pulse wave amplitudes as measured by finger plethysmograph peripheral artery tonometry, and elevated blood CRP levels, in children with psoriasis, are unknown.
We will use the definition of metabolic syndrome described by de Ferranti: Participants are defined as having metabolic syndrome if they meet or exceed the criteria for 3 or more of the following 5 variables: 1) triglycerides ≥1.1 mmol/L; 2) HDL cholesterol <1.3 mmol/L; 3) fasting blood glucose ≥6.1 mmol/L; 4) waist circumference (cm) >75th percentile for age and sex; and 5) systolic or diastolic blood pressure (mm Hg) >90th percentile for age, sex, and height.
The following two noninvasive procedures will be used to assess additional cardiovascular risk: flow mediated dilation (FMD) and finger plethysmography peripheral artery tonometry (PAT). These procedures have been used extensively to measure adults for clinical study purposes for many years.
As a control group, we will compare children with psoriasis to age-, race-,and gender-matched children with warts.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •10-17 year old children with either moderate to severe psoriasis or with warts
- •For psoriasis patients, body surface area covered must be 5% or more or must have had a documented history of 5% or more body surface area involvement
- •Ability to understand and sign an age-appropriate consent form
- •Parent or Guardian over 18 years old able to understand and sign consent form
排除标准
- •Psoriasis or wart patient younger than 10 or 18 years or older
- •For psoriasis patients, body surface area covered less than 5% or have not had a documented history of 5% or more body surface area involvement
- •Inability of child or adult parent/guardian to understand or sign consent
- •Pregnant or lactating females.
结局指标
主要结局
The primary objective of this study is to determine if children with psoriasis will have an increased prevalence of the metabolic syndrome.
时间窗: one assessment
次要结局
- Metabolic syndrome in children with psoriasis will be determined using body weight, BMI, waist circumference, blood pressure, fasting blood sugar, and blood lipid profile.(one assessment)
- Surrogate endpoints indicating potential increased cardiovascular risks, including high sensitivity CRP, flow-mediated dilation (FMD) during reactive hyperemia, and hyperemia-induced, pulse wave amplitudes.(one assessment)
- For psoriasis patients only: PASI, BSA, and PGA will be measured to establish extent of disease.(one assessment)
- Safety Outcome Measures: All adverse events (AEs) will be recorded and monitored.(each occurance)