NCT06842810

Fibroblast Growth Factor 21 in Systemic Lupus Erythematosus

Evaluation of Serum Fibroblast Growth Factor 21 Levels in Patients With Systemic Lupus Erythematosus

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 95 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2025-05-01
• Primary completion: 2027-04-30
• Completion: 2027-12-31
• First posted: 2025-02-24
• Last updated: 2025-02-25