Diabetes MellitusNCT07813793
Role of Triglyceride-Glucose Index and Inflammatory Biomarkers as Prognostic Tools for Progression of Diabetic Nephropathy
An observational study of Diabetes Mellitus and Diabetic Nephropathy, run by Assiut University.
Trial summary
This study aims to evaluate the prognostic value of the Triglyceride-Glucose (TyG) index alongside inflammatory biomarkers in predicting the progression of diabetic nephropathy, exploring their correlation with disease severity to identify accessible, cost-effective markers for early risk stratification and clinical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Diabetic Nephropathy
- How many people
- 105 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Nov 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (≥18 years) with type 1 or type 2 diabetes mellitus, with or without diabetic nephropathy.
Who may be able to join
- Adult patients (≥18 years).
- Patients diagnosed with Type 2 or Type 1 Diabetes Mellitus.
- Patients accepted to provide informed consent and available for clinical examination, blood sampling, and completion of required laboratory investigations (Triglyceride level, fasting glucose, inflammatory markers).
Who cannot join
- Patients with non-diabetic causes of chronic kidney disease (e.g., glomerulonephritis, polycystic kidney disease, obstructive uropathy).
- Patients with acute kidney injury, active urinary tract infection, or other acute inflammatory/infectious conditions that could confound inflammatory biomarker levels.
- Patients on dialysis or with a history of renal transplantation.
- Patients with conditions known to independently alter triglyceride/glucose levels or hematological parameters (PLR, NLR, SII) were excluded, including uncontrolled thyroid disease, active malignancy, current corticosteroid or immunosuppressive therapy, pregnancy, or severe hepatic dysfunction affecting lipid/glucose metabolism; hematological disorders such as hematological malignancies, or thrombocytopenia/thrombocytosis of nondiabetic origin; active infection, sepsis, and recent blood transfusion or use of medications affecting blood cell counts (e.g., chemotherapy, anticoagulants affecting platelet function).
About this study
Official title: Role of Triglyceride-Glucose Index and Inflammatory Biomarkers as Prognostic Tools for Progression of Diabetic Nephropathy: A Cross-Sectional Study
This study aims to evaluate the prognostic value of the Triglyceride-Glucose (TyG) index alongside inflammatory biomarkers in predicting the progression of diabetic nephropathy, exploring their correlation with disease severity to identify accessible, cost-effective markers for early risk stratification and clinical monitoring in diabetic patients.
Read the detailed description
Diabetic nephropathy (DN) is a major microvascular complication of diabetes and a leading cause of chronic kidney disease and end-stage renal disease worldwide . Approximately 30%-40% of people with diabetes develop DN, although prevalence varies by population and region . Clinically, DN is characterized by persistent albuminuria and progressive decline in glomerular filtration rate, and it is strongly linked to cardiovascular events, premature mortality, and major socioeconomic burden . Global burden estimates for 2021 reported 107.6 million prevalent cases, 477.3 thousand deaths, and rising disability-adjusted life years, underscoring the growing public health impact of DN .
Risk stratification in DN is essential for identifying patients at high risk of progression, guiding surveillance intensity, and enabling timely use of renoprotective therapies . Current management relies mainly on albuminuria and estimated glomerular filtration rate, alongside optimization of glycemic control, blood pressure, renin-angiotensin system blockade, SGLT2 inhibitors, GLP-1 receptor agonists, and mineralocorticoid receptor antagonists . However, these conventional markers have important limitations because albuminuria may appear after substantial renal injury, and some patients experience renal decline without marked albuminuria .
Novel biomarkers increasingly focus on metabolic and inflammatory pathways underlying diabetic nephropathy progression . The triglyceride-glucose (TyG) index has emerged as a simple surrogate of insulin resistance and has shown independent association with DN, while inflammatory markers such as TNF-related pathways and interleukin-6 also appear relevant to progression . Among inflammatory indices, NLR has shown the most consistent association with diabetic nephropathy occurrence and progression, while PLR and SII have also been linked to albuminuria, proteinuria, and renal dysfunction in several studies . Still, the evidence remains limited by cross-sectional and single-center designs, heterogeneity, inconsistent cutoffs, and modest standalone accuracy, so larger multicenter longitudinal studies are needed to validate their incremental prognostic value .
- Conditions
- Diabetes Mellitus, Diabetic Nephropathy
- Medical subject headings
- Diabetes Mellitus, Diabetic Nephropathies
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 |
|---|---|---|
| Group A: patients with diabetes mellitus without diabetic nephropathy | Not described | |
| Group B: patients with early-stage DN (Stage 1, Stage 2, and Stage 3a) | Not described | |
| Group C: patients with advanced-stage DN (Stage 3b, Stage 4, Stage 5 not on dialysis) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between the Triglyceride-Glucose (TyG) index and inflammatory biomarkers (NLR, PLR, SII) with the severity/stage of diabetic nephropathy
To evaluate the association between the Triglyceride-Glucose (TyG) index and inflammatory biomarkers (NLR, PLR, SII) with the severity/stage of diabetic nephropathy (based on eGFR and UACR categories, per KDIGO classification), and to determine their diagnostic/prognostic accuracy (sensitivity, specificity, AUC via ROC analysis) in identifying patients at higher risk of DN progression.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Medhat Waheed Saber Khalifa, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07813793
- Sponsor's protocol ID
- TyG, NLR, PLR, and SII in DN
- Status last verified
- Sep 2026
- First submitted
- 5 Sep 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Triglyceride-Glucose Index and Inflammatory Biomarkers as Prognostic Tools for Progression of Diabetic Nephropathy: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07813793
- Acronym / sponsor ID
- TyG, NLR, PLR, and SII in DN
- Conditions
- Diabetes Mellitus, Diabetic Nephropathy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 10 Sep 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.
This study aims to evaluate the prognostic value of the Triglyceride-Glucose (TyG) index alongside inflammatory biomarkers in predicting the progression of diabetic nephropathy, exploring their correlation with disease severity to identify accessible, cost-effective markers for early risk stratification and clinical monitoring in diabetic patients.
Detailed description
Diabetic nephropathy (DN) is a major microvascular complication of diabetes and a leading cause of chronic kidney disease and end-stage renal disease worldwide . Approximately 30%-40% of people with diabetes develop DN, although prevalence varies by population and region . Clinically, DN is characterized by persistent albuminuria and progressive decline in glomerular filtration rate, and it is strongly linked to cardiovascular events, premature mortality, and major socioeconomic burden . Global burden estimates for 2021 reported 107.6 million prevalent cases, 477.3 thousand deaths, and rising disability-adjusted life years, underscoring the growing public health impact of DN .
Risk stratification in DN is essential for identifying patients at high risk of progression, guiding surveillance intensity, and enabling timely use of renoprotective therapies . Current management relies mainly on albuminuria and estimated glomerular filtration rate, alongside optimization of glycemic control, blood pressure, renin-angiotensin system blockade, SGLT2 inhibitors, GLP-1 receptor agonists, and mineralocorticoid receptor antagonists . However, these conventional markers have important limitations because albuminuria may appear after substantial renal injury, and some patients experience renal decline without marked albuminuria .
Novel biomarkers increasingly focus on metabolic and inflammatory pathways underlying diabetic nephropathy progression . The triglyceride-glucose (TyG) index has emerged as a simple surrogate of insulin resistance and has shown independent association with DN, while inflammatory markers such as TNF-related pathways and interleukin-6 also appear relevant to progression . Among inflammatory indices, NLR has shown the most consistent association with diabetic nephropathy occurrence and progression, while PLR and SII have also been linked to albuminuria, proteinuria, and renal dysfunction in several studies . Still, the evidence remains limited by cross-sectional and single-center designs, heterogeneity, inconsistent cutoffs, and modest standalone accuracy, so larger multicenter longitudinal studies are needed to validate their incremental prognostic value .
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A: patients with diabetes mellitus without diabetic nephropathy | – | – |
| Group B: patients with early-stage DN (Stage 1, Stage 2, and Stage 3a) | – | – |
| Group C: patients with advanced-stage DN (Stage 3b, Stage 4, Stage 5 not on dialysis) | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (≥18 years) with type 1 or type 2 diabetes mellitus, with or without diabetic nephropathy.
Key inclusion criteria (3 listed)
- Adult patients (≥18 years).
- Patients diagnosed with Type 2 or Type 1 Diabetes Mellitus.
- Patients accepted to provide informed consent and available for clinical examination, blood sampling, and completion of required laboratory investigations (Triglyceride level, fasting glucose, inflammatory markers).
Key exclusion criteria (4 listed)
- Patients with non-diabetic causes of chronic kidney disease (e.g., glomerulonephritis, polycystic kidney disease, obstructive uropathy).
- Patients with acute kidney injury, active urinary tract infection, or other acute inflammatory/infectious conditions that could confound inflammatory biomarker levels.
- Patients on dialysis or with a history of renal transplantation.
- Patients with conditions known to independently alter triglyceride/glucose levels or hematological parameters (PLR, NLR, SII) were excluded, including uncontrolled thyroid disease, active malignancy, current corticosteroid or immunosuppressive therapy, pregnancy, or severe hepatic dysfunction affecting lipid/glucose metabolism; hematological disorders such as hematological malignancies, or thrombocytopenia/thrombocytosis of nondiabetic origin; active infection, sepsis, and recent blood transfusion or use of medications affecting blood cell counts (e.g., chemotherapy, anticoagulants affecting platelet function).
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
Association between the Triglyceride-Glucose (TyG) index and inflammatory biomarkers (NLR, PLR, SII) with the severity/stage of diabetic nephropathy
Time frame: Baseline
To evaluate the association between the Triglyceride-Glucose (TyG) index and inflammatory biomarkers (NLR, PLR, SII) with the severity/stage of diabetic nephropathy (based on eGFR and UACR categories, per KDIGO classification), and to determine their diagnostic/prognostic accuracy (sensitivity, specificity, AUC via ROC analysis) in identifying patients at higher risk of DN progression.
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 10 Sep 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 Diabetes Mellitus and Diabetic Nephropathy, 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 4 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 10 Sep 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?
Association between the Triglyceride-Glucose (TyG) index and inflammatory biomarkers (NLR, PLR, SII) with the severity/stage of diabetic nephropathy (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 10 Sep 2026.