Peds Metabolic Syndrome in Psoriasis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00930592|
Recruitment Status : Completed
First Posted : June 30, 2009
Last Update Posted : June 21, 2016
|Condition or disease|
|Psoriasis Metabolic Syndrome|
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.
|Study Type :||Observational|
|Actual Enrollment :||42 participants|
|Observational Model:||Case Control|
|Official Title:||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|
|Study Start Date :||April 2009|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||December 2012|
Children with Psoriasis
Children and adolescents from 10-17 years of age with moderate to severe psoriasis.
Control: children with warts
Children and adolescents from 10-17 years of age with warts.
- The primary objective of this study is to determine if children with psoriasis will have an increased prevalence of the metabolic syndrome. [ Time Frame: one assessment ]
- Metabolic syndrome in children with psoriasis will be determined using body weight, BMI, waist circumference, blood pressure, fasting blood sugar, and blood lipid profile. [ Time Frame: 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. [ Time Frame: one assessment ]
- For psoriasis patients only: PASI, BSA, and PGA will be measured to establish extent of disease. [ Time Frame: one assessment ]
- Safety Outcome Measures: All adverse events (AEs) will be recorded and monitored. [ Time Frame: each occurance ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00930592
|United States, Massachusetts|
|Tufts Medical Center, Department of Dermatology|
|Boston, Massachusetts, United States, 02111|
|Principal Investigator:||Alice B. Gottlieb, M.D., PhD.||Tufts Medical Center, Department of Dermatology|