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Assessment of Lipid Profile in Juvenile Systemic Lupus Erythematosus

NCT ID: NCT06151990

Last Updated: 2023-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

102 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-31

Study Completion Date

2025-10-31

Brief Summary

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. 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

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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")

Conditions

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Systemic Lupus Erythematosus

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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newly diagnosed juvenile systemic lupus erythematosus

lipid profile

Intervention Type OTHER

Measurements for CHOL,TG,LDL-C and HDL-C obtained following an overnight fasting

old cases of juvenile systemic lupus in activity

lipid profile

Intervention Type OTHER

Measurements for CHOL,TG,LDL-C and HDL-C obtained following an overnight fasting

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

lipid profile

Intervention Type OTHER

Measurements for CHOL,TG,LDL-C and HDL-C obtained following an overnight fasting

Interventions

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lipid profile

Measurements for CHOL,TG,LDL-C and HDL-C obtained following an overnight fasting

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Sara Abdelnasser Mahmoud

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jaafar I Mohamad, professor

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Naglaa S Mohamad, lecturer

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Yosra M Mamdouh, lecturer

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

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Assiut university

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Sara A Mahmoud, resident

Role: CONTACT

Phone: +02-01144250777

Email: [email protected]

Jaafar I Mohamad, professor

Role: CONTACT

Phone: +02-01020627864

Email: [email protected]

Facility Contacts

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Sara A Mahmoud, resident

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 17265498 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17787042 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26573664 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32935804 (View on PubMed)

Related Links

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https://pubmed.ncbi.nlm.nih.gov/17265498/

Related Info

Other Identifiers

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lipid profile in JSLE

Identifier Type: -

Identifier Source: org_study_id