PsoriasisNCT00930592
Peds Metabolic Syndrome in Psoriasis
An observational study of Psoriasis and Metabolic Syndrome, run by Tufts Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Psoriasis, Metabolic Syndrome
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: These subjects will be recruited from the pediatric Dermatology Clinic at Tufts Medical Center, community physician referral, and advertisements.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Tufts Medical Center, Department of Dermatology
Boston, Massachusetts, 02111
About this study
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
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.
Read the 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.
- Conditions
- Psoriasis, Metabolic Syndrome
- Keywords
- Psoriasis, Metabolic Syndrome, Cardiovascular Risk
- Medical subject headings
- Psoriasis, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study is to determine if children with psoriasis will have an increased prevalence of the metabolic syndrome.
Measured: one assessment
Secondary outcomes (4)
Metabolic syndrome in children with psoriasis will be determined using body weight, BMI, waist circumference, blood pressure, fasting blood sugar, and blood lipid profile.
Measured: 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.
Measured: one assessment
For psoriasis patients only: PASI, BSA, and PGA will be measured to establish extent of disease.
Measured: one assessment
Safety Outcome Measures: All adverse events (AEs) will be recorded and monitored.
Measured: each occurance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2009 (estimated)
- Study startApr 2009
- Primary completionJul 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Sponsor
- Investigators
- Alice B. Gottlieb, M.D., PhD., Principal investigator, Tufts Medical Center, Department of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00930592
- Sponsor's protocol ID
- Peds Metabolic Syndrome
- Status last verified
- Apr 2019
- First submitted
- 29 Jun 2009
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 17032986Neimann 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.
PubMed 17052489Gottlieb AB, Dann F, Menter A. Psoriasis and the metabolic syndrome. J Drugs Dermatol. 2008 Jun;7(6):563-72.
PubMed 18561588Huang 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.
PubMed 17385705Strober 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.
PubMed 18503600Shapiro 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.
PubMed 17157411Paller 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.
PubMed 18199863Kuvin 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.
PubMed 11738283Haller 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.
PubMed 17659060de 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.
PubMed 15477412
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00930592
- Acronym / sponsor ID
- Peds Metabolic Syndrome
- Conditions
- Psoriasis, Metabolic Syndrome
- Keywords
- Psoriasis, Metabolic Syndrome, Cardiovascular Risk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- Apr 2009
- Primary completion
- Jul 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 30 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- These subjects will be recruited from the pediatric Dermatology Clinic at Tufts Medical Center, community physician referral, and advertisements.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
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
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
For psoriasis patients only: PASI, BSA, and PGA will be measured to establish extent of disease.
Time frame: one assessment
Safety Outcome Measures: All adverse events (AEs) will be recorded and monitored.
Time frame: each occurance
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Background: PubMed 17032986Gelfand 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.
- Background: PubMed 17052489Neimann 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.
- Background: PubMed 18561588Gottlieb AB, Dann F, Menter A. Psoriasis and the metabolic syndrome. J Drugs Dermatol. 2008 Jun;7(6):563-72.
- Background: PubMed 17385705Huang 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.
- Background: PubMed 18503600Strober 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.
- Background: PubMed 17157411Shapiro 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.
- Background: PubMed 18199863Paller 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.
- Background: PubMed 11738283Kuvin 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.
- Background: PubMed 17659060Haller 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.
- Background: PubMed 15477412de 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alice B. Gottlieb, M.D., PhD. principal investigator
Tufts Medical Center, Department of Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis and Metabolic Syndrome, run by Tufts Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00930592, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.