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
Sponsor study identifier
observational
42
1 country
1
Study Start
April 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2012
Actual (reported)Study Completion
December 2012
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2012
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2009
Date type not reportedThis date has not been verified as actual or estimated.
June 29, 2009
Actual (reported)June 30, 2009
Actual (reported)July 2012
Actual (reported)December 2012
Actual (reported)The primary objective of this study is to determine if children with psoriasis will have an increased prevalence of the metabolic syndrome.
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.
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.
one assessment
For psoriasis patients only: PASI, BSA, and PGA will be measured to establish extent of disease.
one assessment
Safety Outcome Measures: All adverse events (AEs) will be recorded and monitored.
each occurance
Children and adolescents from 10-17 years of age with moderate to severe psoriasis.
Children and adolescents from 10-17 years of age with warts.
These subjects will be recruited from the pediatric Dermatology Clinic at Tufts Medical Center, community physician referral, and advertisements.
Tufts Medical Center, Department of Dermatology
Boston, Massachusetts, 02111, United States
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.
Whole blood and serum
Alice B. Gottlieb, M.D., PhD.
Tufts Medical Center, Department of Dermatology
42 participants (actual enrollment reported by the registry).
First Submitted
June 29, 2009
First Posted
June 30, 2009
Study Start
April 2009
Date type not reportedThis date has not been verified as actual or estimated.
Methotrexate Versus Secukinumab Safety in Psoriasis Patients With Metabolic Syndrome
Contact the study team to confirm eligibility.
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.
Primary Completion
July 2012
Actual (reported)Study Completion
December 2012
Actual (reported)Last Updated
April 16, 2019
Record last verified: 2019-04
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