Assessment of Lipid Profile in Juvenile Systemic Lupus Erythematosus

Systemic Lupus Erythematosus Clinical Trial

Official title:

Assessment of Lipid Profile in Juvenile Systemic Lupus Erythematosus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06151990
• Other study ID #: lipid profile in JSLE
• Status: Recruiting
• Start date: December 2023
• Est. completion date: October 2025

Study information

• Verified date: September 2023
• Source: Assiut University
• Contact: Sara A Mahmoud, resident
• Phone: +02-01144250777
• Email: saraabdelnassermahmoud1997[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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")

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Est. completion date: October 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

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

Locations

Country	Name	City	State
Egypt	Assiut university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Machado D, Sarni RO, Abad TT, Silva SG, Khazaal EJ, Hix S, Correia MS, Suano-Souza FI, Len CA, Terreri MT. Lipid profile among girls with systemic lupus erythematosus. Rheumatol Int. 2017 Jan;37(1):43-48. doi: 10.1007/s00296-015-3393-z. Epub 2015 Nov 16. — View Citation

Rodrigues WDR, Sarni ROS, Abad TTO, Silva SGLD, Souza FIS, Len CA, Terreri MT. Lipid profile of pediatric patients with chronic rheumatic diseases - a retrospective analysis. Rev Assoc Med Bras (1992). 2020 Aug;66(8):1093-1099. doi: 10.1590/1806-9282.66.8.1093. — View Citation

Sarkissian T, Beyene J, Feldman B, McCrindle B, Silverman ED. Longitudinal examination of lipid profiles in pediatric systemic lupus erythematosus. Arthritis Rheum. 2007 Feb;56(2):631-8. doi: 10.1002/art.22332. — View Citation

Tyrrell PN, Beyene J, Benseler SM, Sarkissian T, Silverman ED. Predictors of lipid abnormalities in children with new-onset systemic lupus erythematosus. J Rheumatol. 2007 Oct;34(10):2112-9. Epub 2007 Sep 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	lipid profile	pattern and frequency of dyslipoproteinemia in patients with newly diagnosed JSLE .	2 years
Primary	lipid profile	effect of disease activity on lipid profile of patients with JSLE	2 years

External Links

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