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NCT07773467Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 19 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
120 (estimated)
First submitted
15 Aug 2026
Start date
Sept 2026
Primary completion date
Sept 2027
Lead sponsor
Assiut University
NCT number
NCT07773467

What you commit to

  • Study type: Observational
  • Planned participants: 120
  • From Sept 2026 to the primary completion date, Sept 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • History of immunosuppressive therapy, systemic corticosteroids, or cytotoxic medications within the past 3 months prior to enrollment.

Other illness

  • 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.

Other

  • Pregnancy.
  • Significant cardiovascular complications.

Who the study is looking for

  • 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).

Age in the registry: 18 years to 80 years · Sex: All

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.