Peds Metabolic Syndrome in Psoriasis

This study has been completed.
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Alice Gottlieb, Tufts Medical Center
ClinicalTrials.gov Identifier:
NCT00930592
First received: June 29, 2009
Last updated: September 16, 2013
Last verified: September 2013

June 29, 2009
September 16, 2013
April 2009
July 2012   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00930592 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • For psoriasis patients only: PASI, BSA, and PGA will be measured to establish extent of disease. [ Time Frame: one assessment ] [ Designated as safety issue: No ]
  • Safety Outcome Measures: All adverse events (AEs) will be recorded and monitored. [ Time Frame: each occurance ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • for psoriasis patients only: PASI, BSA, and PGA will be measured to establish extent of disease. [ Time Frame: one assessment ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples Without DNA
Description:

Whole blood and serum

Non-Probability Sample

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

  • Psoriasis
  • Metabolic Syndrome
Not Provided
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
December 2012
July 2012   (final data collection date for primary outcome measure)

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.
Both
10 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00930592
Peds Metabolic Syndrome
No
Alice Gottlieb, Tufts Medical Center
Tufts Medical Center
Amgen
Principal Investigator: Alice B. Gottlieb, M.D., PhD. Tufts Medical Center, Department of Dermatology
Tufts Medical Center
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP