ClinicalTrials.gg
Not yet recruitingNCT07773467Updated Aug 19, 2026

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

An observational study in Diabetic Kidney Disease, Diabetic Nephropathies and Type 2 Diabetes Mellitus, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-19.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
120
Ages
18 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 25 studies in Diabetic Nephropathies by Assiut University — 16 open to participants now, 16 under way, none of them phase 3. Diabetic Nephropathies · Assiut University.

Planned enrollment
5th of 21
120 · median 92
Started
2026
with 4 others
Observational
21 of 25
14 open now
Primary completion
2027-09
later than 11 of 15 live
Registered
22nd of 25
by date

Among the 25 studies in Diabetic Nephropathies by Assiut University, this one is the 5th largest by planned enrollment of the 21 observational ones, is one of 5 that started in 2026, is one of 21 observational ones, reaches primary completion later than 11 of the 15 other live ones, and was the 22nd registered.

By phase

25 studies; the count open now beside each. This study's row is marked.

Observationalthis study21 · 14 open
No phase4 · 2 open

By the year they started

First in 2016; this study’s year is marked. 5 started in 2026.

Size and results

Median enrollment 78 across the 4 interventional studies, 92 across the 21 observational. Of the 1 that completed or were terminated, 0 (0%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 25 studies in Diabetic Nephropathies by Assiut University, or all of them as a file.
02

Study 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.

03

Conditions studied

  • 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
04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Type 1 diabetes mellitus.
  • Acute infections or clinical signs of active inflammation at the time of sampling.
  • Chronic inflammatory or diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus).
  • Known or recently diagnosed .
  • Chronic liver diseases, including cirrhosis or hepatitis.
  • Nephrotic syndrome or other known non-diabetic kidney diseases.
  • History of therapy, systemic , or cytotoxic medications within the past 3 months prior to enrollment.
  • Pregnancy.
  • Significant cardiovascular complications.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
120 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

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: Baseline

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2026; primary completion for Sep 2027, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 15, 2026
First posted
Aug 19, 2026
StartEst.
Sep 2026
Primary completionEst.
Sep 2027
CompletionEst.
Oct 2027
Last update
Aug 19, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07773467
Lead sponsor
Assiut University
Responsible party
Eman Ali Mohammed Ali (Resident of Clinical Pathology, Assiut University) — Principal investigator
First posted
Aug 19, 2026
Start date
Sep 2026 (estimated)
Primary completion
Sep 2027 (estimated)
Completion
Oct 2027 (estimated)
Last update
Aug 19, 2026
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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