Peds Metabolic Syndrome in Psoriasis

Tufts University

Status: Completed

Conditions: Psoriasis; Metabolic Syndrome

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00930592

Peds Metabolic Syndrome

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 42 patients

Sex: All

Ages: 10 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.

Trial design

42 participants in 2 patient groups

Children with Psoriasis

Description:

Children and adolescents from 10-17 years of age with moderate to severe psoriasis.

Control: children with warts

Description:

Children and adolescents from 10-17 years of age with warts.