Clinical Trials Directory

Trials / Completed

CompletedNCT00930592

Peds Metabolic Syndrome in Psoriasis

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

Status
Completed
Phase
Study type
Observational
Enrollment
42 (actual)
Sponsor
Tufts Medical Center · Academic / Other
Sex
All
Age
10 Years – 17 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed 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.

Conditions

Timeline

Start date
2009-04-01
Primary completion
2012-07-01
Completion
2012-12-01
First posted
2009-06-30
Last updated
2019-04-16

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00930592. Inclusion in this directory is not an endorsement.