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NCT07173686Not yet recruiting

Evaluating The Roles of Novel Inflammatory Markers Compared to MCP-1 in Type 2 Diabetic Nephropathy

Source: ClinicalTrials.gov · Last updated 15 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

Diabetic kidney disease (DKD) is one of the most common microvascular complications of type 2 diabetes mellitus (T2DM), affecting up to 40% of diabetic patients and accounting for the leading cause of end-stage renal disease worldwide \[1\]. The progression of DKD involves multiple mechanisms, including oxidative stress, endothelial dysfunction, and most importantly, chronic inflammation \[2\]. Systemic inflammation plays a central role in renal injury by promoting glomerular and tubulointerstitial damage. the neutrophil-to-lymphocyte ratio (NLR) and systemic inflammatory index (SII) has emerged as a readily accessible markers of subclinical inflammation. Elevated NLR and SII levels have been significantly associated with increased urinary albumin excretion and decreased estimated glomerular filtration rate (eGFR) in T2DM patients \[3\]. It was demonstrated that patients in the highest NLR tertile had a higher prevalence of DKD, independent of confounders \[4\]. High-sensitivity C-reactive protein (hsCRP), is widely used to evaluate systemic inflammation. Recent studies have shown a strong association between elevated hsCRP levels and DKD development \[5\].Some studies provided genetic evidence supporting a causal relationship between higher hsCRP and diabetic nephropathy \[6\]. Monocyte chemoattractant protein-1 (MCP-1) is a chemokine involved in monocyte recruitment to inflamed renal tissues. Elevated serum and urinary MCP-1 levels have been found to predict microalbuminuria and eGFR decline in T2DM patients \[7,8\]. Identifying these markers may help in early diagnosis, risk stratification, and monitoring progression of DKD.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
80 (estimated)
First submitted
8 Sept 2025
Start date
1 Oct 2025
Primary completion date
1 Oct 2026
Lead sponsor
Assiut University
NCT number
NCT07173686

What you commit to

  • Study type: Observational
  • Planned participants: 80
  • From 1 Oct 2025 to the primary completion date, 1 Oct 2026
  • 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.

Other illness

  • Kidney disease caused by any other causes
  • Existing obvious infection
  • Acute stage of cardiovascular or cerebrovascular diseases
  • Acute complications of diabetes recently (such as diabetic ketoacidosis, et al.)
  • Associated malignant tumors
  • Hematological system, and autoimmune system diseases

Lab values

  • Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 - m2

Who the study is looking for

  • Adult aged 18-80 years, both genders.
  • clear history of T2DM

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

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