Overweight and ObesitySIMO-PRONCT07431593
Prognostic Value of SII and SIRI in Obesity-Related Metabolic Complications
An observational study of Overweight and Obesity and Inflammation, run by University of Rijeka at 1 site in Croatia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, Inflammation, Metabolic Syndrome
- What is being tested?
- Nutritional counselling
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteCroatia
- Study dates
- Apr 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study 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.
Who may be able to join
- 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
Who cannot join
- Pregnancy or breastfeeding
- Use of immunosuppressive therapy
- Active infection
- Inflammatory disease
- Malignancy
- Acute illness affecting immune parameters
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Croatia1 site, 1 recruiting
- Recruiting
General Hospital Varaždin
Varaždin
Jelena Vresk Špiranec, MD, specialist in endocrinolog, +385995112141, jelenavresk@gmail.com
About this study
Official title: Clinical Significance and Prognostic Value of Systemic Immune Inflammation Index and Systemic Inflammation Response Index in Obesity and Associated Metabolic Complications
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.
Read the detailed description
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
- Conditions
- Overweight and Obesity, Inflammation, Metabolic Syndrome
- Being tested
- Nutritional counselling
- Keywords
- obesity, overweight, Systemic Immune Inflammatory Index (SII), Systemic Inflammation Response Index (SIRI), inflammation
- Medical subject headings
- Overweight, Obesity, Inflammation, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional counsellingBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Nutritional counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 24 weeks and at study completion, an average of 1 year
Secondary outcomes (5)
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.
Measured: baseline, 24 weeks and at study completion, an average of 1 year
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.
Measured: baseline, 24 weeks and at study completion, an average of 1 year
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.
Measured: baseline, 12 weeks, 24 weeks, and at study completion, an average of 1 year
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.
Measured: baseline, 12 weeks, 24 weeks, and at study completion, an average of 1 year
Relationship Between SII/SIRI and Inflammatory Biomarkers
The associations between SII and SIRI and inflammatory biomarkers will be examined to confirm their biological significance and diagnostic value. This analysis will contribute to understanding the mechanisms of systemic inflammation in the context of obesity and metabolic disorders.
Measured: baseline, 12 weeks, 24 weeks, and at study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study startApr 2026 (estimated)
- Primary completion28 Apr 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rijeka
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gordana Kenđel Jovanović, University of Rijeka
- Investigators
- Gordana Kenđel Jovanović, Asst. Prof., Principal investigator, Faculty of Medicine, University of RijekaSanja Klobučar, Assoc.Prof., Study director, Faculty of Medicine, University of Rijeka; Clinical Hospital Rijeka
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07431593
- Sponsor's protocol ID
- MEDRI-47-2025
- Acronym
- SIMO-PRO
- Status last verified
- Feb 2026
- First submitted
- 11 Feb 2026
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participants' demographics, obesity management treatments, and outcomes.
Publications
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.
PubMed 40381089Barrea 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 Management. Curr Obes Rep. 2025 Sep 8;14(1):68. doi: 10.1007/s13679-025-00662-8.
PubMed 40920291Mirchandani 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.
PubMed 41377417Asemani 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.
PubMed 40247599Liao 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.
PubMed 39885869Zhou 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.
PubMed 39127686Liu 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.
PubMed 39294646Qiu 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.
PubMed 39069464Zhang YZ, Ma RW, Bhandari S, Xie J, Zhang XY, Xie C, Duan H, Meng J, Wu QY, Liu K, Feng B, Cheng LM. Association between systemic immune inflammation index and adolescent obesity in a cross-sectional analysis. Sci Rep. 2025 Feb 22;15(1):6439. doi: 10.1038/s41598-025-91125-6.
PubMed 39987171Uzun H, Fenercioglu AK, Senyigit A, Can G. Relationship Between Nutritional Status and Systemic Immune-Inflammation Indices Across BMI Categories. Nutrients. 2025 Dec 3;17(23):3799. doi: 10.3390/nu17233799.
PubMed 41374089
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Significance and Prognostic Value of Systemic Immune Inflammation Index and Systemic Inflammation Response Index in Obesity and Associated Metabolic Complications
- ClinicalTrials.gov ID
- NCT07431593
- Acronym / sponsor ID
- SIMO-PRO / MEDRI-47-2025
- Conditions
- Overweight and Obesity, Inflammation, Metabolic Syndrome
- Keywords
- obesity, overweight, Systemic Immune Inflammatory Index (SII), Systemic Inflammation Response Index (SIRI), inflammation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of RijekaUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- 28 Apr 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Overweight and obesity cohort | – | Behavioral: Nutritional counsellingAdults 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- Pregnancy or breastfeeding
- Use of immunosuppressive therapy
- Active infection
- Inflammatory disease
- Malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional counsellingParticipants 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. | Behavioural | Overweight and obesity cohort |
Primary outcome
Diagnostic and prognostic value of SII and SIRI
Time frame: baseline, 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.
5 secondary outcomes
Association of SII and SIRI with Metabolic Complications
Time frame: baseline, 24 weeks and at study completion, an average of 1 year
Association of SII and SIRI with Dietary Patterns
Time frame: baseline, 24 weeks and at study completion, an average of 1 year
Identification of Prognostic Markers of Metabolic Comorbidities
Time frame: baseline, 12 weeks, 24 weeks, and at study completion, an average of 1 year
Changes in SII and SIRI During Treatment
Time frame: baseline, 12 weeks, 24 weeks, and at study completion, an average of 1 year
Relationship Between SII/SIRI and Inflammatory Biomarkers
Time frame: baseline, 12 weeks, 24 weeks, and at study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Background: PubMed 40381089Galasso 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.
- Background: PubMed 40920291Barrea 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 Management. Curr Obes Rep. 2025 Sep 8;14(1):68. doi: 10.1007/s13679-025-00662-8.
- Background: PubMed 41377417Mirchandani 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.
- Background: PubMed 40247599Asemani 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.
- Background: PubMed 39885869Liao 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.
- Background: PubMed 39127686Zhou 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.
- Background: PubMed 39294646Liu 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.
- Background: PubMed 39069464Qiu 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.
- Background: PubMed 39987171Zhang YZ, Ma RW, Bhandari S, Xie J, Zhang XY, Xie C, Duan H, Meng J, Wu QY, Liu K, Feng B, Cheng LM. Association between systemic immune inflammation index and adolescent obesity in a cross-sectional analysis. Sci Rep. 2025 Feb 22;15(1):6439. doi: 10.1038/s41598-025-91125-6.
- Background: PubMed 41374089Uzun H, Fenercioglu AK, Senyigit A, Can G. Relationship Between Nutritional Status and Systemic Immune-Inflammation Indices Across BMI Categories. Nutrients. 2025 Dec 3;17(23):3799. doi: 10.3390/nu17233799.
- Individual participant dataSharing planned: Yes. Participants' demographics, obesity management treatments, and outcomes.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gordana Kenđel Jovanović, Asst. Prof. principal investigator
Faculty of Medicine, University of Rijeka
Sanja Klobučar, Assoc.Prof. study director
Faculty of Medicine, University of Rijeka; Clinical Hospital Rijeka
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overweight and Obesity and Inflammation, run by University of Rijeka at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gordana Kenđel Jovanović, Asst.Prof. (+385912030704, gordanakj@uniri.hr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07431593, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.