Systemic Immune-Inflammation Index and Platelet Parameters in Diabetic Kidney Disease

Systemic Immune Inflammation Index With Related Blood Ratios and Platelet Parameters in Patients With Type 2 Diabetes Mellitus and Nephropathy

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07773467

Enrollment

120

Registered

2026-08-19

Start date

2026-09-01

Completion date

2027-10-01

Last updated

2026-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Albuminuria, Diabetic Kidney Disease, Diabetic Nephropathies, Type 2 Diabetes Mellitus

Keywords

Systemic Immune-Inflammation Index, SII, Neutrophil-to-Lymphocyte Ratio, NLR, Platelet-to-Lymphocyte Ratio, PLR, Mean Platelet Volume, MPV, Platelet Parameters, Platelet Distribution Width, Inflammatory Biomarkers

Brief summary

Diabetic kidney disease (DKD) is a frequent microvascular complication in individuals with type 2 diabetes mellitus (T2DM) and a major cause of chronic kidney failure worldwide. Chronic low-grade inflammation and platelet activation contribute significantly to renal microvascular damage. The purpose of this observational study is to evaluate whether routine blood test markers, specifically the Systemic Immune-Inflammation Index (SII), neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), and platelet indices (such as mean platelet volume \[MPV\] and platelet distribution width \[PDW\]), can serve as simple, accessible, and cost-effective biomarkers for identifying the presence and progression of diabetic kidney disease. Participants will include adult patients with type 2 diabetes categorized according to their urinary albumin-to-creatinine ratio (normoalbuminuria, microalbuminuria, and macroalbuminuria) as well as healthy control subjects. Complete blood counts, derived inflammatory indices, and renal parameters will be measured to assess their diagnostic accuracy for DKD.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Inclusion criteria

* Adults aged 18 to 80 years, both males and females. * Confirmed clinical diagnosis and history of Type 2 Diabetes Mellitus (T2DM). * Healthy control subjects matched for age and sex (for the control cohort).

Exclusion criteria

* Type 1 diabetes mellitus. * Acute infections or clinical signs of active inflammation at the time of sampling. * Chronic inflammatory or autoimmune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus). * Known or recently diagnosed malignancies. * Chronic liver diseases, including cirrhosis or hepatitis. * Nephrotic syndrome or other known non-diabetic kidney diseases. * History of immunosuppressive therapy, systemic corticosteroids, or cytotoxic medications within the past 3 months prior to enrollment. * Pregnancy. * Significant cardiovascular complications.

Design outcomes

Primary

Measure	Time frame	Description
Systemic Immune-Inflammation Index (SII) Level	Baseline	Systemic Immune-Inflammation Index calculated as: Platelet count (10\^9/L) × Neutrophil count (10\^9/L) / Lymphocyte count (10\^9/L).

Outcome results