Study Results
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Basic Information
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COMPLETED
42 participants
OBSERVATIONAL
2009-04-30
2012-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Children with Psoriasis
Children and adolescents from 10-17 years of age with moderate to severe psoriasis.
No interventions assigned to this group
Control: children with warts
Children and adolescents from 10-17 years of age with warts.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
10 Years
17 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Tufts Medical Center
OTHER
Responsible Party
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Principal Investigators
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Alice B. Gottlieb, M.D., PhD.
Role: PRINCIPAL_INVESTIGATOR
Tufts Medical Center, Department of Dermatology
Locations
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Tufts Medical Center, Department of Dermatology
Boston, Massachusetts, United States
Countries
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References
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Gelfand JM, Neimann AL, Shin DB, Wang X, Margolis DJ, Troxel AB. Risk of myocardial infarction in patients with psoriasis. JAMA. 2006 Oct 11;296(14):1735-41. doi: 10.1001/jama.296.14.1735.
Neimann AL, Shin DB, Wang X, Margolis DJ, Troxel AB, Gelfand JM. Prevalence of cardiovascular risk factors in patients with psoriasis. J Am Acad Dermatol. 2006 Nov;55(5):829-35. doi: 10.1016/j.jaad.2006.08.040. Epub 2006 Sep 25.
Gottlieb AB, Dann F, Menter A. Psoriasis and the metabolic syndrome. J Drugs Dermatol. 2008 Jun;7(6):563-72.
Huang PH, Chen JW, Lu TM, Yu-An Ding P, Lin SJ. Combined use of endothelial function assessed by brachial ultrasound and high-sensitive C-reactive protein in predicting cardiovascular events. Clin Cardiol. 2007 Mar;30(3):135-40. doi: 10.1002/clc.20058.
Strober B, Teller C, Yamauchi P, Miller JL, Hooper M, Yang YC, Dann F. Effects of etanercept on C-reactive protein levels in psoriasis and psoriatic arthritis. Br J Dermatol. 2008 Aug;159(2):322-30. doi: 10.1111/j.1365-2133.2008.08628.x. Epub 2008 May 22.
Shapiro J, Cohen AD, David M, Hodak E, Chodik G, Viner A, Kremer E, Heymann A. The association between psoriasis, diabetes mellitus, and atherosclerosis in Israel: a case-control study. J Am Acad Dermatol. 2007 Apr;56(4):629-34. doi: 10.1016/j.jaad.2006.09.017. Epub 2006 Dec 8.
Paller AS, Siegfried EC, Langley RG, Gottlieb AB, Pariser D, Landells I, Hebert AA, Eichenfield LF, Patel V, Creamer K, Jahreis A; Etanercept Pediatric Psoriasis Study Group. Etanercept treatment for children and adolescents with plaque psoriasis. N Engl J Med. 2008 Jan 17;358(3):241-51. doi: 10.1056/NEJMoa066886.
Kuvin JT, Patel AR, Sliney KA, Pandian NG, Rand WM, Udelson JE, Karas RH. Peripheral vascular endothelial function testing as a noninvasive indicator of coronary artery disease. J Am Coll Cardiol. 2001 Dec;38(7):1843-9. doi: 10.1016/s0735-1097(01)01657-6.
Haller MJ, Stein J, Shuster J, Theriaque D, Silverstein J, Schatz DA, Earing MG, Lerman A, Mahmud FH. Peripheral artery tonometry demonstrates altered endothelial function in children with type 1 diabetes. Pediatr Diabetes. 2007 Aug;8(4):193-8. doi: 10.1111/j.1399-5448.2007.00246.x.
de Ferranti SD, Gauvreau K, Ludwig DS, Neufeld EJ, Newburger JW, Rifai N. Prevalence of the metabolic syndrome in American adolescents: findings from the Third National Health and Nutrition Examination Survey. Circulation. 2004 Oct 19;110(16):2494-7. doi: 10.1161/01.CIR.0000145117.40114.C7. Epub 2004 Oct 11.
Other Identifiers
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Peds Metabolic Syndrome
Identifier Type: -
Identifier Source: org_study_id
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