PsoriasisNCT01661127
Clinical Study of PET/CT and Association With Metabolic Syndrome/Depressive Symptoms in Psoriasis
An observational study of Psoriasis and Metabolic Syndrome, run by Pusan National University Hospital at 1 site in South Korea.
Trial summary
Psoriasis is associated with increases in markers of inflammation in the skin and blood and increasingly is thought to be a systemic inflammatory disease and risk factor for incident diabetes mellitus, myocardial infarction, stroke, and premature cardiovascular death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis, Metabolic Syndrome, Depression
- How many people
- 10 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2012to Dec 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients of diagnosed with psoriasis in Pusan National University Hospital
Who may be able to join
- Histological diagnosis of plaque type psoriasis
- at least 18 years old
Who cannot join
- those who cannot understand questionnaire
- those who take antidepressant
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of dermatology, Pusan National University Hospital
Busan, Busan
Byung-Soo Kim, Ph D., 82-51-240-7338, dockbs@pusan.ac.kr
About this study
Official title: Phase 0 Clinical Study of PET/CT and Association With Metabolic Syndrome/Depressive Symptoms in Psoriasis
Psoriasis is associated with increases in markers of inflammation in the skin and blood and increasingly is thought to be a systemic inflammatory disease and risk factor for incident diabetes mellitus, myocardial infarction, stroke, and premature cardiovascular death. Furthermore, it is important for clinicians to be aware that psoriasis can have a substantial emotional impact on an individual, which is not necessarily related to the extent of skin disease.
FDG-PET/CT represents an innovative approach to studying systemic inflammation in a manner that is sensitive, quantifiable, and anatomically localizable. Also, recent study show that chronic disease such as end stage renal disease with depressive symptoms have decreased cerebral glucose metabolism in several brain areas in F-18-FDG PET/CT. So this protocol was designed to evaluate usefulness of PET/CT to detect systemic inflammation and abnormality of cerebral glucose metabolism and association with metabolic syndrome/major depressive symptoms in patients with psoriasis.
Read the detailed description
10 Patients with psoriasis
- Evaluate PASI score
- Evaluate comorbidity with metabolic syndrome
- Body mass index(BMI)
- Checking blood pressure
- Checking blood sugar
- Smoking and drinking history
- Checking blood cholesterol level
- Risk factors of cardiovascular disease
- PET/CT for measuring the extent and site of psoriasis with inflammation
- Conditions
- Psoriasis, Metabolic Syndrome, Depression
- Medical subject headings
- Psoriasis, Metabolic Syndrome, Depression
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck depression inventory scoring and Korean Hamilton depression scale scoring
Measured: Day 0 and 28 weeks later
Secondary outcomes (1)
Brain glucose uptake using PET/CT
Measured: Day 0 and 28 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pusan National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Byung-Soo Kim, Ph D., Study chair, Pusan National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01661127
- Sponsor's protocol ID
- PNUHDM-psoriasis
- Status last verified
- Nov 2014
- First submitted
- 7 Aug 2012
- Last updated
- 4 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 0 Clinical Study of PET/CT and Association With Metabolic Syndrome/Depressive Symptoms in Psoriasis
- ClinicalTrials.gov ID
- NCT01661127
- Acronym / sponsor ID
- PNUHDM-psoriasis
- Conditions
- Psoriasis, Metabolic Syndrome, Depression
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Pusan National University HospitalUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 9 Aug 2012 (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.
Psoriasis is associated with increases in markers of inflammation in the skin and blood and increasingly is thought to be a systemic inflammatory disease and risk factor for incident diabetes mellitus, myocardial infarction, stroke, and premature cardiovascular death. Furthermore, it is important for clinicians to be aware that psoriasis can have a substantial emotional impact on an individual, which is not necessarily related to the extent of skin disease.
FDG-PET/CT represents an innovative approach to studying systemic inflammation in a manner that is sensitive, quantifiable, and anatomically localizable. Also, recent study show that chronic disease such as end stage renal disease with depressive symptoms have decreased cerebral glucose metabolism in several brain areas in F-18-FDG PET/CT. So this protocol was designed to evaluate usefulness of PET/CT to detect systemic inflammation and abnormality of cerebral glucose metabolism and association with metabolic syndrome/major depressive symptoms in patients with psoriasis.
Detailed description
10 Patients with psoriasis
- Evaluate PASI score
- Evaluate comorbidity with metabolic syndrome
- Body mass index(BMI)
- Checking blood pressure
- Checking blood sugar
- Smoking and drinking history
- Checking blood cholesterol level
- Risk factors of cardiovascular disease
- PET/CT for measuring the extent and site of psoriasis with inflammation
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of diagnosed with psoriasis in Pusan National University Hospital
Key inclusion criteria (2 listed)
- Histological diagnosis of plaque type psoriasis
- at least 18 years old
Key exclusion criteria (2 listed)
- those who cannot understand questionnaire
- those who take antidepressant
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
Beck depression inventory scoring and Korean Hamilton depression scale scoring
Time frame: Day 0 and 28 weeks later
1 secondary outcome
Brain glucose uptake using PET/CT
Time frame: Day 0 and 28 weeks later
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2014.
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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.
Byung-Soo Kim, Ph D. study chair
Pusan National University Hospital
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 Pusan National University Hospital at 1 site in South Korea.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 4 Nov 2014. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Byung-Soo Kim, Ph D. (82-51-240-7338, dockbs@pusan.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck depression inventory scoring and Korean Hamilton depression scale scoring (time frame: Day 0 and 28 weeks later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Nov 2014.