Fibroblast Growth Factor 21 in Systemic Lupus Erythematosus

NCT06842810 | Not Yet Recruiting

• 1 other identifier: Fibroblast growth factor 21
• Study Type: observational
• Target: 95
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

SLE; Fibroblast growth factor 21

Outcome Measures

Primary Outcomes (1)

• Assessment of serum FGF21 level in SLE patients with and without nephritis in comparison to healthy controls.

  2 years

Study Arms (3)

SLE cases with lupus nephritis

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

SLE cases without lupus nephritis

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

Healthy controls

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

Interventions

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

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

Healthy controls; SLE cases with lupus nephritis; SLE cases without lupus nephritis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

* 50 SLE patients with lupus nephritis * 25 SLE patients without lupus nephritis * 20 healthy controls

You may qualify if:

• \- 1- Patients who will be diagnosed as SLE according to the 2019 EULAR/ACR Classification criteria for Systemic Lupus Erythematosus.
• SLE Patients \> 18 years old.

You may not qualify if:

• SLE Patients \< 18 years old. 2- Patients with other rheumatic diseases or overlap syndromes. 3- Patients with malignancy. 4- Patients with liver diseases.

Sponsors & Collaborators

• Assiut University: lead

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: February 24, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 25, 2025

Record last verified: 2025-02