Diabetic Kidney DiseaseNCT07773467
Systemic Immune-Inflammation Index and Platelet Parameters in Diabetic Kidney Disease
An observational study of Diabetic Kidney Disease and Diabetic Nephropathies, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Kidney Disease, Diabetic Nephropathies, Type 2 Diabetes Mellitus
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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.
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- History of immunosuppressive therapy, systemic corticosteroids, or cytotoxic medications within the past 3 months prior to enrollment.
- Pregnancy.
- Significant cardiovascular complications.
About this study
Official title: Systemic Immune Inflammation Index With Related Blood Ratios and Platelet Parameters in Patients With Type 2 Diabetes Mellitus and Nephropathy
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.
- 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
- Medical subject headings
- Diabetic Nephropathies, Diabetes Mellitus, Type 2, Albuminuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Ali Mohammed Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07773467
- Sponsor's protocol ID
- SII and Platelets in DKD
- Status last verified
- Aug 2026
- First submitted
- 15 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Immune Inflammation Index With Related Blood Ratios and Platelet Parameters in Patients With Type 2 Diabetes Mellitus and Nephropathy
- ClinicalTrials.gov ID
- NCT07773467
- Acronym / sponsor ID
- SII and Platelets in DKD
- Keywords
- Systemic Immune-Inflammation Index, SII, Neutrophil-to-Lymphocyte Ratio, NLR, Platelet-to-Lymphocyte Ratio, PLR, Mean Platelet Volume, MPV
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 19 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Kidney Disease and Diabetic Nephropathies, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systemic Immune-Inflammation Index (SII) Level (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.