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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07173686
Enrollment
80
Registered
2025-09-15
Start date
2025-10-01
Completion date
2026-11-01
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Nephropathy

Brief summary

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.

Interventions

None listed

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Kidney disease caused by any other causes * Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 - m2 * 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

Design outcomes

Primary

MeasureTime frameDescription
MCP-1 levelbaselineAssessment the role of MCP-1 in early detection of diabetic nephropathy.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026