Assessment of Lipid Profile in Juvenile Systemic Lupus Erythematosus

Sponsor
Assiut University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06151990
Collaborator
(none)
102
1
22
4.6

Study Details

Study Description

Brief Summary

. To determine pattern and frequency of dyslipoproteinemia in patients with newly diagnosed juvenile SLE and to assess effect of disease activity on lipid profile of patients with juvenile SLE.

Condition or Disease Intervention/Treatment Phase
  • Other: lipid profile

Detailed Description

Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterized by multisystem inflammation and the presence of circulating autoantibodies against self-antigens leading to inflammatory damage of many target organs including the skin, joints, kidneys, blood cells, blood vessels, and the central nervous system.Premature atherosclerosis has been recognized as an important issue for patients with SLE since the mid-1970s. Among the traditional risk factors of atherosclerosis, a history of smoking, diabetes, hypertension, and abnormal lipid profile have been shown to be important (7). In patients with juvenile SLE, smoking, diabetes, and uncontrolled hypertension are not common and therefore abnormal lipid profiles may be the most important risk factor.The lipid profile of both children and adults with SLE is the result of a combination of the influences of active disease, therapies, and genetics. The best way to determine the maximal potential effect of disease activity itself would be to examine patients at the time of presentation of SLE, when they are likely to have high disease activity but no effect of corticosteroid therapy.Studies in patients with active SLE suggested that there is a distinct pattern of lipid abnormalities of increased very low-density lipoprotein (VLDL) and triglycerides and decreased high-density lipoprotein (HDL-C), cholesterol and apolipoprotein A1 levels ("active SLE pattern")

Study Design

Study Type:
Observational
Anticipated Enrollment :
102 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Assessment of Lipid Profile in Juvenile Systemic Lupus Erythematosus
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2025
Anticipated Study Completion Date :
Oct 1, 2025

Arms and Interventions

Arm Intervention/Treatment
newly diagnosed juvenile systemic lupus erythematosus

Other: lipid profile
Measurements for CHOL,TG,LDL-C and HDL-C obtained following an overnight fasting

old cases of juvenile systemic lupus in activity

Other: lipid profile
Measurements for CHOL,TG,LDL-C and HDL-C obtained following an overnight fasting

old cases of juvenile systemic lupus not in activity(controlled)

Other: lipid profile
Measurements for CHOL,TG,LDL-C and HDL-C obtained following an overnight fasting

Outcome Measures

Primary Outcome Measures

  1. lipid profile [2 years]

    pattern and frequency of dyslipoproteinemia in patients with newly diagnosed JSLE .

  2. lipid profile [2 years]

    effect of disease activity on lipid profile of patients with JSLE

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Patients who are diagnosed according to 2019 European League against Rheumatism (EULAR) /American College of Rheumatology (ACR) SLE classification criteria .

  2. Patients diagnosed with jSLE between 5 and 18 years of age

Exclusion Criteria:
    1. Patients on lipid lowering drugs for any other reason. 2. Patients with other autoimmune disease.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Assiut university Assiut Egypt

Sponsors and Collaborators

  • Assiut University

Investigators

  • Principal Investigator: Jaafar I Mohamad, professor, Assiut University
  • Principal Investigator: Naglaa S Mohamad, lecturer, Assiut University
  • Principal Investigator: Yosra M Mamdouh, lecturer, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Sara Abdelnasser Mahmoud, principal investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT06151990
Other Study ID Numbers:
  • lipid profile in JSLE
First Posted:
Nov 30, 2023
Last Update Posted:
Nov 30, 2023
Last Verified:
Sep 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 30, 2023