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

Официальное название

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

Обзор

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.

Подробное описание

Obesity is a complex chronic disease associated with systemic low-grade inflammation, metabolic dysfunction, and increased risk of comorbidities such as type 2 diabetes, dyslipidemia, nonalcoholic fatty liver disease, and cardiovascular disease. Adipose tissue acts as an active endocrine organ, influencing immune regulation and inflammatory signalling. Although numerous inflammatory biomarkers have been evaluated in obesity, the diagnostic performance of novel composite systemic immune-inflammatory indices, particularly the systemic immune-inflammation index (SII) and the systemic inflammation response index (SIRI), remains inadequately characterised. SII and SIRI, derived from peripheral blood counts, have shown prognostic potential in various clinical settings but have not been systematically evaluated in predicting metabolic complications or treatment response in obesity. This study seeks to expand their application in patients with overweight and obesity by 1) evaluating the cross-sectional associations between SII/SIRI and obesity severity, inflammatory biomarkers, metabolic disorders, and dietary patterns; and 2) determining the prognostic value of SII/SIRI for predicting metabolic complications and clinical response to behavopural and lifestyle modification, pharmacotherapy, and bariatric surgery over a 1-year follow-up.

Participants will complete anthropometric measurements, comprehensive biochemical profiling, inflammatory cytokine assessment, dietary evaluation, and structured follow-up at 12 and 24 weeks, with continued monitoring of treatment response and metabolic outcomes over 1 year.

STUDY PROCEDURES (Structured per visit) Visit 1 - Baseline (Week 1)

* Informed consent * Anthropometrics (height, weight, waist circumference, hip circumference, BIA) * Venous blood sampling: complete blood count (CBC) and differential blood count (DBC), fasting glucose, HbA1c, lipid profile (cholesterol, LDL, HDL, triglycerides), thyroid panel (TSH, FT4, FT3), liver panel, renal panel, CRP, cortisol, bilirubin, iron status parameters, vitamins/minerals (Ca, P, Mg, vitamin D) * Biobanking: 3 frozen aliquots for hs-CRP, adiponectin, IL-6, TNF-α * Lifestyle and dietary questionnaires (socio-demographics, physical activity, smoking, sleep, stress, medication use; 24 h dietary recall + FFQ) * Motivational and educational counselling (diet, activity, pharmacotherapy options)

Visit 2 - Week 12

* Anthropometrics + BIA * Laboratory testing (repeated, as above) * Assessment of dietary and lifestyle adherence * Motivational counselling (in person or telephone)

Visit 3 - Week 24

* Anthropometrics + BIA * Full biochemical panel * Dietary questionnaires (24 h recall+MEDAS+Short Diet Screener) * Evaluation of treatment response to lifestyle intervention, pharmacotherapy, or bariatric surgery * Motivational counselling

LONG-TERM FOLLOW-UP (Year 1)

* Monitoring metabolic outcomes * Evaluation of obesity treatment response * Prognostic assessment of SII/SIRI

Вмешательства

• Поведенческое Nutritional 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. Du

Первичные конечные точки

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

Вторичные конечные точки (5)

• Association of SII and SIRI with Metabolic Complications [Срок оценки: baseline, 24 weeks and at study completion, an average of 1 year]
• Association of SII and SIRI with Dietary Patterns [Срок оценки: baseline, 24 weeks and at study completion, an average of 1 year]
• Identification of Prognostic Markers of Metabolic Comorbidities [Срок оценки: baseline, 12 weeks, 24 weeks, and at study completion, an average of 1 year]
• Changes in SII and SIRI During Treatment [Срок оценки: baseline, 12 weeks, 24 weeks, and at study completion, an average of 1 year]
• Relationship Between SII/SIRI and Inflammatory Biomarkers [Срок оценки: baseline, 12 weeks, 24 weeks, and at study completion, an average of 1 year]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Хорватия · 1 центр

• General Hospital Varaždin — Varaždin

Публикации

• Galasso M, Verde L, Barrea L, Savastano S, Colao A, Fruhbeck G, Muscogiuri G. The Impact of Different Nutritional Approaches on Body Composition in People Living with Obesity. Curr Obes Rep. 2025 May 17;14(1):45. doi: 10.1007/s13679-025-00636-w. PMID 40381089
• Barrea L, Verde L, Annunziata G, Chedraui P, Petraglia F, Cucalon G, Camajani E, Caprio M, Gorini S, Iorio GG, Di Girolamo R, Carbone L, Chapela S, Frias-Toral E, Muscogiuri G. Effectiveness of Medical Nutrition Therapy in the Management of Patients with Obesity and Endometriosis: from the Mediterranean Diet To the Ketogenic Diet, Through Supplementation. The Role of the Nutritionist in Clinical M PMID 40920291
• Mirchandani M, Jeanty H, Sahu S, Nejati H, Adla Jala SR, Mahapatro A, Jain SM, Nasrollahizadeh A, Arezoo G, Hashemi SM, Amini-Salehi E. Exploring the Systemic Immune-Inflammation Index as a novel biomarker for nonalcoholic fatty liver disease: a systematic review and meta-analysis. Ann Med Surg (Lond). 2025 Oct 15;87(12):8748-8756. doi: 10.1097/MS9.0000000000004097. eCollection 2025 Dec. PMID 41377417
• Asemani S, Jourabchi-Ghadim N, Arefhosseini S, Ebrahimi-Mameghani M. Weight-adjusted waist index and its relationship with systemic inflammatory Index and metabolic indices in overweight and obese individuals: A cross-sectional study. Sci Prog. 2025 Apr-Jun;108(2):368504251333218. doi: 10.1177/00368504251333218. Epub 2025 Apr 17. PMID 40247599
• Liao Y, Zhou K, Lin B, Deng S, Weng B, Pan L. Associations between systemic immune-inflammatory index and visceral adipose tissue area: results of a national survey. Front Nutr. 2025 Jan 16;11:1517186. doi: 10.3389/fnut.2024.1517186. eCollection 2024. PMID 39885869
• Zhou Y, Wang Y, Wu T, Zhang A, Li Y. Association between obesity and systemic immune inflammation index, systemic inflammation response index among US adults: a population-based analysis. Lipids Health Dis. 2024 Aug 10;23(1):245. doi: 10.1186/s12944-024-02240-8. PMID 39127686
• Liu X, Zhang Y, Li Y, Sang Y, Chai Y, Zhang L, Zhang H. Systemic immunity-inflammation index is associated with body fat distribution among U.S. adults: evidence from national health and nutrition examination survey 2011-2018. BMC Endocr Disord. 2024 Sep 18;24(1):189. doi: 10.1186/s12902-024-01725-y. PMID 39294646
• Qiu L, Ren Y, Li J, Li M, Li W, Qin L, Ning C, Zhang J, Gao F. Association of systemic immune inflammatory index with obesity and abdominal obesity: A cross-sectional study from NHANES. Nutr Metab Cardiovasc Dis. 2024 Oct;34(10):2409-2419. doi: 10.1016/j.numecd.2024.06.003. Epub 2024 Jun 13. PMID 39069464

Идентификаторы

NCT: NCT07431593 · MEDRI-47-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗