Interleukin 38 as a Biomarker for Metabolic Syndrome in Psoriatic Patients

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: Psoriasis
• Intervention / Treatment: Diagnostic test: measure plasma level of interleukin 38 by ELISA kit

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

• 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

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

How is the study designed?

Number of groups / cohorts

4

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	Diagnostic test: measure plasma level of interleukin 38 by ELISA kit; 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	Diagnostic test: measure plasma level of interleukin 38 by ELISA kit; 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	Diagnostic test: measure plasma level of interleukin 38 by ELISA kit; 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	Diagnostic test: measure plasma level of interleukin 38 by ELISA kit; 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	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

• Sponsor: Sohag University
• Investigators: Principal Investigator: yomna a abdellatif, MBBCH

Study record dates

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: metabolic syndrome; psoriasis; interleukin 38
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Skin Diseases; Skin Diseases, Papulosquamous; Insulin Resistance; Hyperinsulinism; Psoriasis; Metabolic Syndrome
• 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