Effect of Gender on Clinical Presentation of SLE ِAt Assiut University Hospitals

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04234633
Collaborator
(none)
150
24

Study Details

Study Description

Brief Summary

The investigators aim to compare the clinical characteristics and outcomes of SLE between male and female Egyptian patients at Assuit University Hospital.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Systemic lupus erythematosus (SLE) is an autoimmune disease of unknown etiology and is characterized by a multifaceted clinical presentation and disease course. Female predominance is a well-known characteristic of SLE, particularly during the reproductive years. Sex differences are another peculiarity of SLE with respect to clinical manifestations and outcomes. Previous studies have recognized male patients with lupus as a distinct minority; such patients often exhibit a poorer prognosis, especially involving the renal, cardiovascular, and neurologic systems. Higher mortality rates in male than in female patients with SLE have also been reported. Andrade et al reported that multiple conditions (for example, severe skin lesions, serositis, thrombotic events, and seizures) are more frequent in males than females.

    Lu et al investigated the frequency of renal failure and end-stage renal disease among both genders and found out that these conditions were more prevalent among males. Another study shows no difference in complications and prognosis between both genders.

    The results of these previous studies may not be applicable to all ethnic groups. For example, Mok et al studied the males in the local Chinese population had different disease features in term of clinical features at diagnosis, rate, and severity of relapse, organ damage and cumulative damage score. They found through a retrospective review that at the time of diagnosis, there was a trend, however not statistically significant, that males had less Raynaud's, alopecia, arthritis, anti-Ro antibody, but more thrombocytopenia and discoid lesions. Also, a significantly higher number of males had impaired renal functions.

    There are few studies that have assessed the differences between male and female Egyptian patients with SLE according to the presentation, complication, prognosis, and mortality. One of these studies shows a more aggressive disease detected in male patients. This was evident by a higher prevalence of nephritis, fever, cutaneous vasculitis in male patients. on the other hand, alopecia and arthritis were significantly higher in females.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    150 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Effect of Gender on Clinical Presentation of SLE ِAt Assiut University Hospitals
    Anticipated Study Start Date :
    Mar 1, 2020
    Anticipated Primary Completion Date :
    Mar 1, 2022
    Anticipated Study Completion Date :
    Mar 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    SLE patients

    Any SLE patients between 18 and 40 years old.

    Outcome Measures

    Primary Outcome Measures

    1. Presentation, complication, and mortality among males and female patients with SLE [2 years]

      Using percentages, we will track the number of patients that develop certain clinical conditions (such as arthritis, malar rash, .... ), complications (such as nephritis), and mortality rates. These numbers and percentages will be used to compare males with females (incidence rates for each event will be calculated).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Any SLE patients between 18and 40 years old will be eligible to be included in our study.

    Exclusion Criteria:
    • Patients below the age of 18 or above 40.

    • Any other autoimmune disease.

    • Cardiovascular, neurological, renal complications due to other co-morbidity such as DM and HTN.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    • Principal Investigator: Ahmed Aeltaih, MBBch, Assuit University Hospitals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmed Safwat ِِِAbd elhamid eltaih, Principal Investigator, Assiut University
    ClinicalTrials.gov Identifier:
    NCT04234633
    Other Study ID Numbers:
    • A44
    First Posted:
    Jan 21, 2020
    Last Update Posted:
    Jan 21, 2020
    Last Verified:
    Jan 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jan 21, 2020