Clinical trial

Prognostic Value of SII and SIRI in Obesity-Related Metabolic Complications

Recruiting now · Not applicable · 1 countries · Registry ID NCT07431593

Recruiting nowNot applicableObservational

What this study is about

This observational study aims to evaluate the diagnostic and prognostic value of the systemic immune-inflammatory index (SII) and the systemic inflammation response index (SIRI) in individuals with overweight or obesity. The study will assess their association with obesity status, metabolic complications, lifestyle patterns, dietary indices, and established inflammatory biomarkers. Participants will undergo anthropometric assessment, laboratory testing, dietary evaluation, and follow-up for response to different obesity treatment modalities over 3 years. The study intends to determine whether SII and SIRI can serve as clinically useful predictors of metabolic risk and treatment outcomes of obesity.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersAccepted

ConditionOverweight and Obesity, Inflammation, Metabolic Syndrome

Full registry 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

Treatments and study arms

Nutritional counselling

Behavioral

Participants will receive interventions that are part of routine medical care, i.e. structured personalised nutritional intervention aligned with the Croatian Guidelines for the Treatment of Adults with Obesity. It emphasises lifestyle modification, energy-reduced dietary patterns, and the adoption of healthy eating habits as the first-line approach to weight management. The intervention consists of a 30-minute individualised counselling session delivered by a licensed nutrition professional. During the session, participants are guided to adopt a Mediterranean diet, with goal-setting, portion guidance, and strategies to increase adherence. The routine medical intervention aligned with the guidelines' recommendation for a nutritionally balanced diet combined with a modest daily energy deficit (\~500 kcal) to support gradual, sustainable weight loss and long-term weight maintenance.

Primary outcomes

Diagnostic and prognostic value of SII and SIRIbaseline, 24 weeks and at study completion, an average of 1 year

The diagnostic and prognostic value of systemic inflammation indices (SII and SIRI) will be assessed using ROC curve analysis, including sensitivity, specificity, and AUC calculations.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

General Hospital Varaždin🌐 Varaždin, Croatia

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Jelena Vresk Špiranec, MD, specialist in endocrinologContact

Email · Call +385995112141