Psoriasis VulgarisNCT03932110
Metabolic Syndrome in Psoriasis and Psoriatic Arthritis and Correlation With Serum Omentin and Visfatin Levels
A study testing omentin, visfatin in people with Psoriasis Vulgaris and Psoriatic Arthritis, run by Istanbul Medeniyet University at 2 sites in Turkey (Türkiye).
Trial summary
In this study, the prevalence of metabolic syndrome in psoriatic and psoriatic arthritis patients as well as the parameters of metabolic syndrome will be examined. At the same time, the levels of omentin and visfatin adipokines associated with metabolic syndrome and obesity will be measured by measuring the disease… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis Vulgaris, Psoriatic Arthritis, Metabolic Syndrome
- What is being tested?
- omentin, visfatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 Apr 2019to 14 Jun 2019
- Phase
- Interventional
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients followed up for psoriasis and psoriatic arthritis in dermatology and rheumatology clinic
- Patients older than 18 years
- Patients who accept dermatological and rheumatic examination
- Patients not receiving systemic treatment related to the disease in the last 1 month
Who cannot join
- Patients with autoimmune and rheumatic diseases other than psoriasis and psoriatic arthritis
- Patients under 18 years
- Patients who do not accept dermatological and rheumatic examination Patients receiving systemic therapy for the last 1 month pregnant and nursing moms
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Istanbul Medeniyet University, Department of dermatology
Istanbul, 34722
Istanbul Medeniyet University
Istanbul, 34722
About this study
Official title: The Prevalence of Metabolic Syndrome in Patients With Psoriasis and Psoriatic Arthritis and Its Correlation With Disease Severity and Serum Omentin-1 and Visfatin Levels
In this study, the prevalence of metabolic syndrome in psoriatic and psoriatic arthritis patients as well as the parameters of metabolic syndrome will be examined. At the same time, the levels of omentin and visfatin adipokines associated with metabolic syndrome and obesity will be measured by measuring the disease severity (by PASI psoriasis, clinical activity score for psoriatic arthritis). The patients who accepted to participate in the study , who were admitted to the dermatology outpatient clinic were included in the study. For the blood tests required after the examination, 2 tubes of blood will be taken for the measurement of omentin and visfatin. 80 psoriasis, 40 psoriatic arthritis and 60 healthy volunteers were planned to be studied. AHA / NHLBI, 2005 (revised ATP III criteria) criterion for the diagnosis of metabolic syndrome will be used. Omentin and visfatin levels are compared with the severity of the disease for psoriasis and psoriatic arthritis, and it will be examined whether it is proinflammatory or antiinflammatory.
- Conditions
- Psoriasis Vulgaris, Psoriatic Arthritis, Metabolic Syndrome
- Being tested
- omentin, visfatin
- Keywords
- psoriasis vulgaris, psoriatic arthritis, metabolic syndrome, omentin, visfatin
- Medical subject headings
- Arthritis, Psoriatic, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omentin, visfatinDiagnostic test
diagnostic blood test
| Study group | Role | What they receive |
|---|---|---|
| psoriasis vulgaris, | Other | patients who have only psoriasis vulgaris Receives: Diagnostic Test: omentin, visfatin |
| psoriatic arthritis | Other | patients who have psoriatic arthritis Receives: Diagnostic Test: omentin, visfatin |
| healthy control | Other | healthy people Receives: Diagnostic Test: omentin, visfatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
omentin
Omentin (omentin 1-2) is a specific protein that consists of amino acids released from vascular vessels
Measured: 6 months
visfatin
Visfatin is an insulin-like protein that binds to insulin receptors produced mostly from visceral fatty tissue.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2019
- Study start15 Apr 2019
- Primary completion1 Jun 2019
- Study completion14 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis VulgarisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deniz Dağdelen, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03932110
- Sponsor's protocol ID
- DDagdelen
- Status last verified
- Jun 2019
- First submitted
- 24 Apr 2019
- Last updated
- 17 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence of Metabolic Syndrome in Patients With Psoriasis and Psoriatic Arthritis and Its Correlation With Disease Severity and Serum Omentin-1 and Visfatin Levels
- ClinicalTrials.gov ID
- NCT03932110
- Acronym / sponsor ID
- DDagdelen
- Conditions
- Psoriasis Vulgaris, Psoriatic Arthritis, Metabolic Syndrome
- Keywords
- psoriasis vulgaris, psoriatic arthritis, metabolic syndrome, omentin, visfatin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 14 Jun 2019 (actual)
- First posted
- 30 Apr 2019 (actual)
- 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.
In this study, the prevalence of metabolic syndrome in psoriatic and psoriatic arthritis patients as well as the parameters of metabolic syndrome will be examined. At the same time, the levels of omentin and visfatin adipokines associated with metabolic syndrome and obesity will be measured by measuring the disease severity (by PASI psoriasis, clinical activity score for psoriatic arthritis). The patients who accepted to participate in the study , who were admitted to the dermatology outpatient clinic were included in the study. For the blood tests required after the examination, 2 tubes of blood will be taken for the measurement of omentin and visfatin. 80 psoriasis, 40 psoriatic arthritis and 60 healthy volunteers were planned to be studied. AHA / NHLBI, 2005 (revised ATP III criteria) criterion for the diagnosis of metabolic syndrome will be used. Omentin and visfatin levels are compared with the severity of the disease for psoriasis and psoriatic arthritis, and it will be examined whether it is proinflammatory or antiinflammatory.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| psoriasis vulgaris, | Other | Diagnostic Test: omentin, visfatinpatients who have only psoriasis vulgaris |
| psoriatic arthritis | Other | Diagnostic Test: omentin, visfatinpatients who have psoriatic arthritis |
| healthy control | Other | Diagnostic Test: omentin, visfatinhealthy people |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients followed up for psoriasis and psoriatic arthritis in dermatology and rheumatology clinic
- Patients older than 18 years
- Patients who accept dermatological and rheumatic examination
- Patients not receiving systemic treatment related to the disease in the last 1 month
Key exclusion criteria (3 listed)
- Patients with autoimmune and rheumatic diseases other than psoriasis and psoriatic arthritis
- Patients under 18 years
- Patients who do not accept dermatological and rheumatic examination Patients receiving systemic therapy for the last 1 month pregnant and nursing moms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| omentin, visfatindiagnostic blood test | Diagnostic test | healthy control, psoriasis vulgaris,, psoriatic arthritis |
Primary outcome
omentin
Time frame: 6 months
Omentin (omentin 1-2) is a specific protein that consists of amino acids released from vascular vessels
visfatin
Time frame: 6 months
Visfatin is an insulin-like protein that binds to insulin receptors produced mostly from visceral fatty tissue.
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 17 Jun 2019.
- Individual participant dataSharing planned: No
Related trials for Psoriasis Vulgaris
Active, not recruitingPhase 4
Residual Disease MEMory in PSOriasis Skin During EnstiLAR® and Narrow-band Ultraviolet B Therapy: The MEMPSOLAR Study
Psoriasis Vulgaris, Psoriasis
RecruitingObservational study
Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
Acne, Atopic Dermatitis
RecruitingPhase 4
Topical Diacerein in Psoriasis Vulgaris
Psoriasis Vulgaris
Not yet recruiting
Ceramol PSOR Cream as an Adjuvant Treatment in Patients With Mild-to-Moderate Psoriasis Treated With Narrowband UVB Phototherapy (CERAMOL PSOR CREMA)
Psoriasis, Psoriasis; Plaque
RecruitingPhase 1
A Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of HRS-4139 in Healthy Participants
Psoriasis Vulgaris
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing omentin, visfatin in people with Psoriasis Vulgaris and Psoriatic Arthritis, run by Istanbul Medeniyet University at 2 sites in Turkey (Türkiye).
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 3 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 17 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
omentin (time frame: 6 months). The study lists 2 primary outcomes in all. 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 17 Jun 2019.