Clinical trial NCT06151990: Assessment of Lipid Profile in Juvenile Systemic Lupus Erythematosus
Official title: Assessment of Lipid Profile in Juvenile Systemic Lupus Erythematosus
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Systemic Lupus Erythematosus
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-11-30
Enrollment: 102
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: .Patients diagnosed with jSLE between 5 and 18 years of age

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.

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")

Eligibility criteria: 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.

Primary outcomes:
measure: lipid profile
timeFrame: 2 years
measure: lipid profile
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
affiliation: Assiut University
name: Jaafar I Mohamad, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Assiut University
name: Naglaa S Mohamad, lecturer
role: PRINCIPAL_INVESTIGATOR
affiliation: Assiut University
name: Yosra M Mamdouh, lecturer
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
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.