Prognostic Value of SII and SIRI in Obesity-Related Metabolic Complications
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Rijeka
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Pregnancy or breastfeeding
Use of immunosuppressive therapy
Active infection
Inflammatory disease
Trial population
The study population consists of adults with overweight or obesity who are receiving obesity management at outpatient obesity clinics. Eligible participants are 18 years or older and have a BMI between 25.0-29.9 kg/m² (overweight) or BMI ≥ 30 kg/m² (obesity). All participants must be able to attend scheduled clinical visits and must provide written informed consent.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Nutritional counselling
BehavioralParticipants 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.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Overweight and obesity cohort1 intervention
Trial outcomes
Primary outcomes
1
Diagnostic and prognostic value of SII and SIRI
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.
Time frame
baseline, 24 weeks and at study completion, an average of 1 yearSecondary outcomes
1
Association of SII and SIRI with Metabolic Complications
The association of SII and SIRI with metabolic complications (insulin resistance, dyslipidemia, NAFLD) and their ability to predict response to obesity treatment (behavioural and pharmacologic) will be evaluated.
Time frame
baseline, 24 weeks and at study completion, an average of 1 year2
Association of SII and SIRI with Dietary Patterns
The relationship between SII/SIRI and adherence to anti-inflammatory and pro-inflammatory dietary patterns will be examined using indices such as the Mediterranean Diet Index and the Dietary Inflammatory Index. The analysis will provide insight into the impact of diet quality on systemic inflammation over time.
Time frame
baseline, 24 weeks and at study completion, an average of 1 year3
Identification of Prognostic Markers of Metabolic Comorbidities
Inflammatory indices (SII, SIRI) and monitored biomarkers will be analysed to determine their ability to predict the development or progression of obesity-related metabolic complications. The aim is to identify early indicators of increased risk for adverse metabolic outcomes and help in providing timely and appropriate obesity management.
Time frame
baseline, 12 weeks, 24 weeks, and at study completion, an average of 1 year4
Changes in SII and SIRI During Treatment
Longitudinal changes in SII and SIRI will be monitored throughout the treatment period to assess the degree and sustainability of systemic inflammation reduction. Results will be associated with clinical outcomes and treatment effectiveness.
Time frame
baseline, 12 weeks, 24 weeks, and at study completion, an average of 1 yearSponsors and contacts
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Source ClinicalTrials.gov