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

Sponsor
University of Rijeka
Study ID
NCT07431593
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Feb 24, 2026
Start date
Apr 30, 2026
Status verified
Feb 2026
Primary completion
Apr 28, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: Overweight and obesity cohort
    Adults with overweight or obesity presenting to outpatient obesity clinics. Participants aged ≥18 years with BMI ≥25 kg/m² undergoing clinical evaluation for obesity. All participants will follow the same assessment and follow-up schedule; variation occurs only in the type of treatment chosen (lifestyle, pharmacotherapy, bariatric surgery).

Primary Outcome Measure

Diagnostic and prognostic value of SII and SIRI [ Time Frame: baseline, 24 weeks and at study completion, an average of 1 year ]

Central Contacts

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