Blood-count inflammation scores (SII and SIRI) to predict metabolic complications in adults with overweight or obesity
Official title: Clinical Significance and Prognostic Value of Systemic Immune Inflammation Index and Systemic Inflammation Response Index in Obesity and Associated Metabolic Complications
Run by University of Rijeka · NCT07431593 · Data updated 2026-11-12
This project will test whether two blood-count-based scores (SII and SIRI) can help predict metabolic complications and treatment response in adults with overweight or obesity.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | University of Rijeka Academic / other |
| Locations | 1 site (Varaždin) |
| Status | Recruiting |
| Started | April 2026 |
| Main results expected | April 28, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | May 7, 2026 |
| Trial ID | NCT07431593 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older with BMI ≥25 who can attend clinic visits and agree to blood tests, dietary evaluation, and follow-up are the intended participants.
✕Probably not a fit
People with active infection, pregnancy or breastfeeding, immunosuppressive therapy, known hematologic or chronic inflammatory disorders, recent major surgery, or other conditions that alter leukocyte or platelet counts are unlikely to benefit from SII/SIRI-based predictions.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational cohort will enroll adults with BMI ≥25 and collect baseline anthropometry, routine blood counts for SII/SIRI, metabolic labs, inflammatory cytokines, and dietary assessments. Participants receive nutritional counselling as part of usual care and may undergo behavioral, pharmacologic, or bariatric treatments as clinically indicated. Investigators will analyze cross-sectional links between SII/SIRI, obesity severity, dietary patterns, established inflammatory markers, and metabolic disorders, and will test whether baseline SII/SIRI predict metabolic complications and treatment response. Follow-up visits and laboratory testing are planned for up to one year to capture clinical outcomes and treatment responses.
Why it matters
Potential benefit: If successful, SII and SIRI could offer inexpensive, widely available blood-based markers to help stratify metabolic risk and inform treatment decisions for people with overweight or obesity.
How similar studies have gone: SII and SIRI have shown prognostic promise in cancer and cardiovascular settings but have not been systematically validated for predicting metabolic complications or treatment response in obesity, making this a relatively novel application.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria * Age ≥ 18 years * BMI 25.0-29.9 kg/m² (overweight) or BMI ≥ 30 kg/m² (obesity) * Ability to attend scheduled clinical visits * Willingness to provide informed consent Exclusion Criteria * Pregnancy or breastfeeding * Use of immunosuppressive therapy * Active infection * Inflammatory disease * Malignancy * Acute illness affecting immune parameters * Conditions interfering with study participation (as assessed by the investigator) * Known hematologic disorders affecting leukocyte or platelet counts * Chronic inflammatory diseases requiring systemic therapy * Recent major surgery (within the last 3 months) * Any condition that could confound the relationship between SII/SIRI and obesity-driven inflammation, such as immune disorders
Where it's running
-
General Hospital Varaždin
Varaždin, Croatia Recruiting
Study contacts
- Principal investigator: Gordana Kenđel Jovanović, Asst. Prof. — Faculty of Medicine, University of Rijeka
- Study coordinator: Gordana Kenđel Jovanović, Asst.Prof.
- Email: gordanakj@uniri.hr
- Phone: +385912030704
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.