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Peds Metabolic Syndrome in Psoriasis

11 april 2019 bijgewerkt door: Tufts Medical Center

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

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Werkelijk)

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Verenigde Staten
- Massachusetts
  - Boston, Massachusetts, Verenigde Staten, 02111
    - Tufts Medical Center, Department of Dermatology

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

10 jaar tot 17 jaar (Kind)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

These subjects will be recruited from the pediatric Dermatology Clinic at Tufts Medical Center, community physician referral, and advertisements.

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Aantal groepen / cohorten

Cohorten en interventies

Groep / Cohort
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Tijdsspanne
The primary objective of this study is to determine if children with psoriasis will have an increased prevalence of the metabolic syndrome. Tijdsspanne: one assessment	one assessment

Secundaire uitkomstmaten

Uitkomstmaat	Tijdsspanne
Metabolic syndrome in children with psoriasis will be determined using body weight, BMI, waist circumference, blood pressure, fasting blood sugar, and blood lipid profile. Tijdsspanne: one assessment	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. Tijdsspanne: one assessment	one assessment
For psoriasis patients only: PASI, BSA, and PGA will be measured to establish extent of disease. Tijdsspanne: one assessment	one assessment
Safety Outcome Measures: All adverse events (AEs) will be recorded and monitored. Tijdsspanne: each occurance	each occurance

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Tufts Medical Center

Medewerkers

Amgen

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Tufts Medical Center, Department of Dermatology, Research

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 april 2009

Primaire voltooiing (Werkelijk)

1 juli 2012

Studie voltooiing (Werkelijk)

1 december 2012

Studieregistratiedata

Eerst ingediend

29 juni 2009

Eerst ingediend dat voldeed aan de QC-criteria