RecruitingNCT07431593

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

Clinical Significance and Prognostic Value of Systemic Immune Inflammation Index and Systemic Inflammation Response Index in Obesity and Associated Metabolic Complications

Sponsor

University of Rijeka

Enrollment

200 participants

Start Date

Apr 1, 2026

Study Type

OBSERVATIONAL

Conditions

Metabolic Syndrome Inflammation Overweight and Obesity

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

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 Criteria11

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

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Interventions

BEHAVIORALNutritional counselling

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.