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
  Purpose

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.


Condition
Psoriasis
Metabolic Syndrome

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
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

Resource links provided by NLM:


Further study details as provided by Tufts Medical Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples Without DNA

Whole blood and serum


Enrollment: 42
Study Start Date: April 2009
Study Completion Date: December 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   10 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00930592

Locations
United States, Massachusetts
Tufts Medical Center, Department of Dermatology
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts Medical Center
Amgen
Investigators
Principal Investigator: Alice B. Gottlieb, M.D., PhD. Tufts Medical Center, Department of Dermatology
  More Information

Additional Information:
Publications:

Responsible Party: Alice Gottlieb, Principal Investigator, Tufts Medical Center
ClinicalTrials.gov Identifier: NCT00930592     History of Changes
Other Study ID Numbers: Peds Metabolic Syndrome
Study First Received: June 29, 2009
Last Updated: September 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Tufts Medical Center:
Psoriasis
Metabolic Syndrome
Cardiovascular Risk

Additional relevant MeSH terms:
Psoriasis
Metabolic Syndrome X
Skin Diseases, Papulosquamous
Skin Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 24, 2014