Assessment of Lipid Profile in Juvenile Systemic Lupus Erythematosus

November 21, 2023 updated by: Sara Abdelnasser Mahmoud, Assiut University
. 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

102

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

Study Contact Backup

Study Locations

  • Egypt
      • Assiut, Egypt
        • Recruiting
        • Assiut University
        • Contact:
        • Principal Investigator:
          • Jaafar I Mohamed, professor
        • Principal Investigator:
          • Naglaa S Mohamed, lecturer
        • Principal Investigator:
          • Yosra M Mamdouh, lecturer

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

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
lipid profile
Time Frame: 2 years
pattern and frequency of dyslipoproteinemia in patients with newly diagnosed JSLE .
2 years
lipid profile
Time Frame: 2 years
effect of disease activity on lipid profile of patients with JSLE
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 (Estimated)

December 1, 2023

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

November 13, 2023

First Submitted That Met QC Criteria

November 21, 2023

First Posted (Actual)

November 30, 2023

Study Record Updates

Last Update Posted (Actual)

November 30, 2023

Last Update Submitted That Met QC Criteria

November 21, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • lipid profile in JSLE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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