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

NCT07773467 | Not Yet Recruiting

• 1 other identifier: SII and Platelets in DKD
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

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

Outcome Measures

Primary Outcomes (1)

• Systemic Immune-Inflammation Index (SII) Level

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

  Baseline

Study Arms (4)

T2DM with Normoalbuminuria

30 adult patients diagnosed with type 2 diabetes mellitus presenting with normoalbuminuria, defined as urinary albumin-to-creatinine ratio (uACR) \< 30 mg/g creatinine.

T2DM with Microalbuminuria

30 adult patients diagnosed with type 2 diabetes mellitus presenting with microalbuminuria, defined as urinary albumin-to-creatinine ratio (uACR) between 30 and 299 mg/g creatinine.

T2DM with Macroalbuminuria

30 adult patients diagnosed with type 2 diabetes mellitus presenting with macroalbuminuria, defined as urinary albumin-to-creatinine ratio (uACR) ≥ 300 mg/g creatinine.

Healthy Controls

30 age- and sex-matched healthy control individuals without diabetes, renal impairment, or chronic inflammatory disease.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients aged 18 to 80 years diagnosed with type 2 diabetes mellitus attending Assiut University Hospitals, categorized based on urinary albumin-to-creatinine ratio (uACR) into normoalbuminuria, microalbuminuria, and macroalbuminuria, alongside healthy control subjects.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Diabetic Nephropathies; Diabetes Mellitus, Type 2; Albuminuria

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Proteinuria; Urination Disorders; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Clinical Pathology

Study Record Dates

• First Submitted: August 15, 2026
• First Posted: August 19, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: August 19, 2026

Record last verified: 2026-08