Using albumin-to-globulin ratio and PNI to predict lupus activity
Using Combination of Albumin to Globulin Ratio and Prognostic Nutritional Index Model for Predicting Disease Activity in Patients With Systemic Lupus Erythematosus
This project will test whether combining the albumin-to-globulin ratio (AGR) and the prognostic nutritional index (PNI) can help predict disease activity in adults with lupus.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sohag University Academic / other |
| Locations | 1 site (Sohag) |
| Trial ID | NCT07043153 on ClinicalTrials.gov |
What this trial studies
This observational study will measure albumin and globulin levels to calculate AGR and compute the prognostic nutritional index, then correlate those markers with clinical signs and routine laboratory measures of SLE activity. Adults who meet the SLICC classification for SLE and matched controls will be enrolled at Sohag University hospitals. Key exclusions include other chronic inflammatory or autoimmune diseases, recent infection, malignancy, pregnancy or lactation, and significant liver or renal insufficiency to reduce confounding. The aim is to develop a simple, non-invasive, and low-cost marker panel that could complement existing clinical and laboratory assessments of disease activity.
Who should consider this trial
Good fit: Adults (≥18) diagnosed with systemic lupus erythematosus by SLICC criteria who can attend visits at Sohag University hospitals are the intended participants.
Not a fit: Patients with other chronic inflammatory/autoimmune conditions, active infection, malignancy, significant liver or kidney failure, children, and pregnant or breastfeeding people are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, clinicians could use simple blood-based measures to monitor lupus activity more easily and affordably.
How similar studies have performed: Related nutritional and inflammatory blood markers have shown promise in other inflammatory and autoimmune diseases, but the specific combination of AGR and PNI in SLE is relatively novel and not yet widely validated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * · Age ≥ 18 years. * Both sexes. * Patients diagnosed with SLE who fulfilling the Systemic Lupus International Collaborating Clinics (SLICC) classification criteria and matched controls. Exclusion Criteria: * Co-existing chronic inflammatory or autoimmune diseases. * Age \<18 years * Malignancy. * Pregnancy or lactation. * Chronic liver or renal insufficiency. * Malignant hematologic diseases. * Active hepatitis. * Acute infection within the previous four weeks
Where this trial is running
Sohag
- Sohag University hospitals — Sohag, Egypt (Recruiting)
Study contacts
- Study coordinator: Hala A Hamid, Master
- Email: Hala.hamed@med.sohag.edu.eg
- Phone: 20 01122385665
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.