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

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.

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Key information

Conditions

Diabetic Kidney Disease Albuminuria Diabetes Complications Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetic Nephropathies Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Proteinuria Signs and Symptoms Type 2 Diabetes Mellitus Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Systemic Immune-Inflammation Index (SII) Level

Time frame: Baseline

Systemic Immune-Inflammation Index calculated as: Platelet count (10^9/L) × Neutrophil count (10^9/L) / Lymphocyte count (10^9/L).

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Aug 19, 2026
Registry last updated: Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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