PsoriasisNCT05076812
Interleukin 38 as a Biomarker for Metabolic Syndrome in Psoriatic Patients
An observational study of Psoriasis, run by Sohag University.
Trial summary
case control study to compare level of interleukin 38 in patients with psoriasis and patients with metabolic syndrome with healthy control subjects Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- What is being tested?
- measure plasma level of interleukin 38 by ELISA kit
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- Oct 2021to Dec 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: people attending the Dermatology Outpatient Clinics of Sohag University Hospital.
Who may be able to join
- specific to each group
Who cannot join
- Patient refusal. Age <18 years Pregnancy Lactation smoking Infections. Patients with other inflammatory skin disorders use of antioxidant and anti-inflammatory drugs patients on treatment for psoriasis
Trial locations and contacts
No sites are listed yet.
wafaa m abdel-magid, asst prof contact
About this study
case control study to compare level of interleukin 38 in patients with psoriasis and patients with metabolic syndrome with healthy control subjects
Read the detailed description
this case control study will measure plasma level of interleukin 38 in 4 groups of 24 subject, group one will have psoriatic patients, group 2 will have psoriatic patients with metabolic syndrome, group three will have patients with metabolic syndrome only, and group 4 will have healthy control subjects.
- Conditions
- Psoriasis
- Being tested
- measure plasma level of interleukin 38 by ELISA kit
- Keywords
- psoriasis, metabolic syndrome, interleukin 38
- 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.
measure plasma level of interleukin 38 by ELISA kitDiagnostic test
draw 5 ml of venous blood into EDTA tubes and centrifuged then plasma is separated for test
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Psoriasis only) | contains 24 psoriatic patients, Psoriasis Area Severity Index will be measured, also waist circumference, body mass index, blood pressure, fasting blood glucose and fasting lipid profile and finally: plasma level of interleukin 38 Receives: Diagnostic Test: measure plasma level of interleukin 38 by ELISA kit | |
| Group 2 (Psoriasis and metabolic syndrome) | contains 24 psoriatic patients with metabolic syndrome. Psoriasis Area Severity Index will be measured metabolic syndrome is diagnosed after measuring waist circumference, body mass index, blood pressure, fasting blood glucose and fasting lipid profile finally: plasma level of interleukin 38 Receives: Diagnostic Test: measure plasma level of interleukin 38 by ELISA kit | |
| Group 3 (Metabolic syndrome only) | contains 24 patients with metabolic syndrome only. full dermatological examination to exclude psoriasis and other inflammatory skin disorders metabolic syndrome is diagnosed after measuring waist circumference, body mass index, blood pressure, fasting blood glucose and fasting lipid profile finally: plasma level of interleukin 38 Receives: Diagnostic Test: measure plasma level of interleukin 38 by ELISA kit | |
| Group 4 (Healthy Controls) | contains 24 healthy control subjects full dermatological examination to exclude psoriasis and other inflammatory skin disorders metabolic syndrome is excluded after measuring waist circumference, body mass index, blood pressure, fasting blood glucose and fasting lipid profile finally: plasma level of interleukin 38 Receives: Diagnostic Test: measure plasma level of interleukin 38 by ELISA kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
measure plasma level of interleukin 38 in all groups
level of interleukin 38 will be measured and compared in all groups to asses the relationship between this interleukin and metabolic syndrome in psoriatic patients
Measured: through study completion an average of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2021
- Study startOct 2021 (estimated)
- Primary completionMay 2022 (estimated)
- Study completionDec 2022 (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.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yomna Abdo Abdellatif, Sohag University
- Investigators
- yomna a abdellatif, MBBCH, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05076812
- Sponsor's protocol ID
- Soh-Med-21-09-02
- Status last verified
- Oct 2021
- First submitted
- 20 Sep 2021
- Last updated
- 21 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interleukin 38 as a Biomarker for Metabolic Syndrome in Psoriatic Patients
- ClinicalTrials.gov ID
- NCT05076812
- Acronym / sponsor ID
- Soh-Med-21-09-02
- Conditions
- Psoriasis
- Keywords
- psoriasis, metabolic syndrome, interleukin 38
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Oct 2021 (estimated)
- Primary completion
- May 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 13 Oct 2021 (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.
case control study to compare level of interleukin 38 in patients with psoriasis and patients with metabolic syndrome with healthy control subjects
Detailed description
this case control study will measure plasma level of interleukin 38 in 4 groups of 24 subject, group one will have psoriatic patients, group 2 will have psoriatic patients with metabolic syndrome, group three will have patients with metabolic syndrome only, and group 4 will have healthy control subjects.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Psoriasis only) | – | Diagnostic Test: measure plasma level of interleukin 38 by ELISA kitcontains 24 psoriatic patients, Psoriasis Area Severity Index will be measured, also waist circumference, body mass index, blood pressure, fasting blood glucose and fasting lipid profile and finally: plasma level of interleukin 38 |
| Group 2 (Psoriasis and metabolic syndrome) | – | Diagnostic Test: measure plasma level of interleukin 38 by ELISA kitcontains 24 psoriatic patients with metabolic syndrome. Psoriasis Area Severity Index will be measured metabolic syndrome is diagnosed after measuring waist circumference, body mass index, blood pressure, fasting blood glucose and fasting lipid profile finally: plasma level of interleukin 38 |
| Group 3 (Metabolic syndrome only) | – | Diagnostic Test: measure plasma level of interleukin 38 by ELISA kitcontains 24 patients with metabolic syndrome only. full dermatological examination to exclude psoriasis and other inflammatory skin disorders metabolic syndrome is diagnosed after measuring waist circumference, body mass index, blood pressure, fasting blood glucose and fasting lipid profile finally: plasma level of interleukin 38 |
| Group 4 (Healthy Controls) | – | Diagnostic Test: measure plasma level of interleukin 38 by ELISA kitcontains 24 healthy control subjects full dermatological examination to exclude psoriasis and other inflammatory skin disorders metabolic syndrome is excluded after measuring waist circumference, body mass index, blood pressure, fasting blood glucose and fasting lipid profile finally: plasma level of interleukin 38 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- people attending the Dermatology Outpatient Clinics of Sohag University Hospital.
Key inclusion criteria (1 listed)
- specific to each group
Key exclusion criteria (1 listed)
- Patient refusal. Age <18 years Pregnancy Lactation smoking Infections. Patients with other inflammatory skin disorders use of antioxidant and anti-inflammatory drugs patients on treatment for psoriasis
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 |
|---|---|---|
| measure plasma level of interleukin 38 by ELISA kitdraw 5 ml of venous blood into EDTA tubes and centrifuged then plasma is separated for test | Diagnostic test | Group 1 (Psoriasis only), Group 2 (Psoriasis and metabolic syndrome), Group 3 (Metabolic syndrome only), Group 4 (Healthy Controls) |
Primary outcome
measure plasma level of interleukin 38 in all groups
Time frame: through study completion an average of 18 months
level of interleukin 38 will be measured and compared in all groups to asses the relationship between this interleukin and metabolic syndrome in psoriatic patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2021.
- Individual participant dataSharing planned: Undecided
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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.
wafaa m abdel-magid, asst prof contact
yomna a abdellatif, MBBCH principal investigator
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis, run by Sohag University.
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 1 inclusion and 1 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 21 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Yomna A Abdellatif, MBBCH (01119200320 ext. +2, yomna.a.abdellatif@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measure plasma level of interleukin 38 in all groups (time frame: through study completion an average of 18 months). 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 21 Oct 2021.