NCT05076812

Brief Summary

case control study to compare level of interleukin 38 in patients with psoriasis and patients with metabolic syndrome with healthy control subjects

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2021

Completed
11 days until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 13, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

October 21, 2021

Status Verified

October 1, 2021

Enrollment Period

7 months

First QC Date

September 20, 2021

Last Update Submit

October 13, 2021

Conditions

Keywords

psoriasismetabolic syndromeinterleukin 38

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (4)

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

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

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

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

Interventions

draw 5 ml of venous blood into EDTA tubes and centrifuged then plasma is separated for test

Group 1 (Psoriasis only)Group 2 (Psoriasis and metabolic syndrome)Group 3 (Metabolic syndrome only)Group 4 (Healthy Controls)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

people attending the Dermatology Outpatient Clinics of Sohag University Hospital.

You may qualify if:

  • specific to each group

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

PsoriasisMetabolic Syndrome

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • yomna a abdellatif, MBBCH

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yomna A Abdellatif, MBBCH

CONTACT

wafaa m abdel-magid, asst prof

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident doctor in dermatology venereology and andrology department in sohag university hospital

Study Record Dates

First Submitted

September 20, 2021

First Posted

October 13, 2021

Study Start

October 1, 2021

Primary Completion

May 1, 2022

Study Completion

December 1, 2022

Last Updated

October 21, 2021

Record last verified: 2021-10