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Fibroblast Growth Factor 21 in Systemic Lupus Erythematosus

NCT06842810 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 95

Last updated 2025-02-25

No results posted yet for this study

Summary

Systemic lupus erythematosus (SLE) is a chronic disorder characterized by profound immune and metabolic disturbances. It emerges due to a complex interplay of genetic and environmental factors. Alteration in immune cell metabolism is another feature of SLE. Mitochondria, serving as the main regulator of cell metabolism, exhibits pronounced dysfunction in SLE patients.

Kidneys are among the most frequently affected organs in SLE, with 30-40% of patients developing lupus nephritis (LN) over the course of their disease. LN patients exhibit varying degrees of renal injury, significantly reducing their survival rate. Usually, LN originates from abnormal immune responses, resulting in the formation and deposition of immune complexes in the kidneys, triggering the release of pro-inflammatory cytokines, cell adhesion molecules, and chemokines, thereby inducing inflammation. Extensive glomerular mitochondrial damage has been reported in kidney biopsies obtained from patients with LN. So, identifying peripheral immune markers of mitochondrial dysfunction may be beneficial in assessing SLE activity and the extent of organ involvement.

Among these markers, fibroblast growth factor 21 (FGF-21) is one of the circulating immune markers which is expressed in response to mitochondrial stress. FGF-21 is known to be primarily produced in the liver, but under stress conditions, it can also be produced by the kidneys. In addition, it correlates with the degree of renal impairment in various kidney diseases.

Conditions

  • Systemic Lupus Erthematosus

Interventions

DIAGNOSTIC_TEST

Serum FGF21 measurement by Enzyme- linked immunosorbent assay (ELISA)

Venous 5 ml blood will be collected, then centrifugation at the speed of 2000-3000 rpm for 20-min., supernatant will be collected and stored at -20°C for later analysis then tha sample will be tested for fibroblast growth factor 21

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-01
Primary Completion
2027-04-30
Completion
2027-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06842810 on ClinicalTrials.gov