ClinicalTrials.gg
Not yet recruitingNCT07813793Updated Sep 10, 2026

Role of Triglyceride-Glucose Index and Inflammatory Biomarkers as Prognostic Tools for Progression of Diabetic Nephropathy

An observational study in Diabetes Mellitus and Diabetic Nephropathy, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.

Primary conditionDiabetic NephropathiesRegistry: Diabetes MellitusReclassifiedWhy we changed it
Registry
Diabetes Mellitus — the first condition term the registry derived for this study.
ClinicalTrials.gg
Diabetic Nephropathies
Why
  1. The study's listed conditions name Diabetic Nephropathies, a narrower term within Diabetes Mellitus.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Assiut University · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
105
Ages
18 Years and older
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
7th of 21
105 · median 92
Started
2026
with 4 others
Observational
21 of 25
14 open now
Primary completion
2027-10
later than 12 of 15 live
Registered
23rd of 25
by date

Among the 25 studies in Diabetic Nephropathies by Assiut University, this one is the 7th 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 12 of the 15 other live ones, and was the 23rd 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

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 .

03

Conditions studied

  • Diabetes Mellitus
  • Diabetic Nephropathy

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04

In context

Diabetic Nephropathies Reclassified

543 studies on the registry are indexed under Diabetic Nephropathies; 110 are open to participants now.

This study's planned enrollment of 105 is below the median of 188 across 138 observational studies indexed under Diabetic Nephropathies.

Browse Diabetic Nephropathies studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Compared within Diabetic Nephropathies, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Diabetes Mellitus. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients (≥18 years) with type 1 or type 2 diabetes mellitus, with or without diabetic nephropathy.

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

  • Adult patients (≥18 years).
  • Patients diagnosed with Type 2 or Type 1 Diabetes Mellitus.
  • Patients accepted to provide and available for clinical examination, blood sampling, and completion of required laboratory investigations (Triglyceride level, fasting glucose, inflammatory markers).

Exclusion criteria

Exclusion Criteria:

  • 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 , current or 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 function).
Terms in these criteria, in plain language(5)

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.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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.

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.

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.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

06

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
105 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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)
07

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline

08

Study locations

No study locations are listed for this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

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

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

Registered
Sep 5, 2026
First posted
Sep 10, 2026
StartEst.
Oct 1, 2026
Primary completionEst.
Oct 1, 2027
CompletionEst.
Nov 1, 2027
Last update
Sep 10, 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 Sep 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07813793
Lead sponsor
Assiut University
Responsible party
Medhat Waheed Saber Khalifa (Resident Physician, Assiut University) — Principal investigator
First posted
Sep 10, 2026
Start date
Oct 1, 2026 (estimated)
Primary completion
Oct 1, 2027 (estimated)
Completion
Nov 1, 2027 (estimated)
Last update
Sep 10, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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

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Discussion

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