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

NCT ID: NCT07173686

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2026-11-01

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.

Conditions

Diabetic Nephropathy

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1

diabetic patients without diabetic nephropathy (albumin/creatinine ratio: \< 30 mg alb/gm creatinine )

No interventions assigned to this group

Group2

diabetic patients with first stage diabetic nephropathy ( albumin/creatinine ratio: 30-300 mg alb/gm creatinine)

No interventions assigned to this group

Group 3

diabetic patients with second stage diabetic nephropathy (albumin/creatinine ratio \>300 mg alb/gm creatinine)

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Naira Ali Mohammed Soliman

residant doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

MCP-1 DM 2

Identifier Type: -

Identifier Source: org_study_id