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

NCT07173686 | Not Yet Recruiting

• 1 other identifier: MCP-1 DM 2
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• MCP-1 level

  Assessment the role of MCP-1 in early detection of diabetic nephropathy.

  baseline

Study Arms (3)

Group 1

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

Group2

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

Group 3

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Diabetic Nephropathies

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: residant doctor

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: September 15, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: September 15, 2025

Record last verified: 2025-09