Systemic Immune-Inflammation Index and Platelet Parameters in Diabetic Kidney Disease
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorAssiut University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
120 Participants
are grouped into 4 trial groupsGroup A: T2DM with Normoalbuminuria
Group B: T2DM with Microalbuminuria
Group C: T2DM with Macroalbuminuria
Group D: Healthy Controls
Trial outcomes
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).
Time frame
BaselineLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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