Interleukin 38 as a Biomarker for Metabolic Syndrome in Psoriatic Patients
October 13, 2021 updated by: Yomna Abdo Abdellatif, Sohag University
case control study to compare level of interleukin 38 in patients with psoriasis and patients with metabolic syndrome with healthy control subjects
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Anticipated)
96
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yomna A Abdellatif, MBBCH
- Phone Number: +2 01119200320
- Email: yomna.a.abdellatif@gmail.com
Study Contact Backup
- Name: wafaa m abdel-magid, asst prof
- Phone Number: +2 0 100 8813349
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
people attending the Dermatology Outpatient Clinics of Sohag University Hospital.
Description
Inclusion Criteria:
- specific to each group
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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
|
draw 5 ml of venous blood into EDTA tubes and centrifuged then plasma is separated for test
|
|
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
|
draw 5 ml of venous blood into EDTA tubes and centrifuged then plasma is separated for test
|
|
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
|
draw 5 ml of venous blood into EDTA tubes and centrifuged then plasma is separated for test
|
|
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
|
draw 5 ml of venous blood into EDTA tubes and centrifuged then plasma is separated for test
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
through study completion an average of 18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: yomna a abdellatif, MBBCH
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
October 1, 2021
Primary Completion (ANTICIPATED)
May 1, 2022
Study Completion (ANTICIPATED)
December 1, 2022
Study Registration Dates
First Submitted
September 20, 2021
First Submitted That Met QC Criteria
September 29, 2021
First Posted (ACTUAL)
October 13, 2021
Study Record Updates
Last Update Posted (ACTUAL)
October 21, 2021
Last Update Submitted That Met QC Criteria
October 13, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soh-Med-21-09-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
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