Diagnostic Value of Serum Cathepsin S and Chromogranin A in DKD

Diabetic Kidney Disease Clinical Trial

Official title:

Diagnostic Value of Serum Cathepsin S and Chromogranin A in Diabetic Kidney Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06069076
• Other study ID #: Diabetic kidney disease
• Status: Not yet recruiting
• Start date: November 1, 2023
• Est. completion date: October 1, 2026

Study information

• Verified date: October 2023
• Source: Assiut University
• Contact: Zeinab kamel
• Phone: 01060247896
• Email: zozet2013[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

1. Evulate the diagnostic value of serum cathepsin S and chromogranin A for Diabetic kidney disease.

2. To correlate the levels of serum Cathepsin S and chromogranin A with HbA1c and eGFR in type 2 diabetic patients based on urinary Albumin- Creatinine Ratio.

Description:

Diabetic nephropathy (DN) is a common and serious complication of diabetes and has been shown to be a major cause of end-stage renal disease (ESRD), requiring costly renal replacement therapy in the form of dialysis or transplantation .

It is appreciated that up to 40% of patients with type 1 and type 2 diabetes mellitus (DM) present DN . Early detection and appropriate treatment are essential to prevent disability and death.

Cathepsin S (Cat-S) was a secreted cysteine proteolytic enzyme that is mainly expressed in macrophages. Macrophages undergoing chemotaxis adhere to the basement membrane of blood vessels and secrete Cat-S, and the secreted Cat-S was involved in hydrolysis of elastin, laminin, collagen and other extracellular matrix components, causing vascular damage .

So, Cathepsin S(Cat-S), a novel non-invasive diagnostic marker mediates vascular endothelial dysfunction.

In recent years, studies have shown that up regulation of Cat-S was associated with the development of IgA nephropathy, lupus nephritis, insulin resistance, diabetes and other renal diseases.

Chromogranin A (CgA) is the main member of the chromogranin family and is an acidic glycoprotein consisting of 439 amino acids with an approximate molecular mass of 48 kDa. CgA is used as a diagnostic marker of neuroendocrine tumors(6). The kidney is the main site for the removal of CgA, and it is retained in serum with declining renal function. In patients with renal failure, serum CgA increases much more than creatinine and the other studied low-MW proteins.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 92
• Est. completion date: October 1, 2026
• Est. primary completion date: October 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• patients diagnosed as type 2 Diabetes mellitus

• Patients with T2DM with normoalbuminuria , microalbuminuria and macroalbuminuria.

Exclusion Criteria:

• Renal impairment of other Known origin,

• Type 1 D,

• Hepatic disease,

• Heart failure,

• Thyroid disorders,

• Autoimmune disorders,

• Inflammatory condition,

• Malignancy,

• Urinary tract infection,

• Pregnancy.

Related Conditions & MeSH terms

• Diabetic Kidney Disease
• Diabetic Nephropathies
• Kidney Diseases

Intervention

Diagnostic Test:
• cathepsin S and chromogranin A
Diagnostic value of serum Cathepsin S and Chromogranin A

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (2)

Ren X, Wang W, Cao H, Shao F. Diagnostic value of serum cathepsin S in type 2 diabetic kidney disease. Front Endocrinol (Lausanne). 2023 May 25;14:1180338. doi: 10.3389/fendo.2023.1180338. eCollection 2023. — View Citation

Yu H, Wang H, Su X, Cao A, Yao X, Wang Y, Zhu B, Wang H, Fang J. Serum chromogranin A correlated with albuminuria in diabetic patients and is associated with early diabetic nephropathy. BMC Nephrol. 2022 Jan 21;23(1):41. doi: 10.1186/s12882-022-02667-0. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evulate the diagnostic value of serum cathepsin S and chromogranin A for Diabetic kidney disease.	Evaluation of the clinical utility of the measurement of the level of Cathepsin S and chromogranin A in type 2 diabetic nephropathy.	Baseline
Secondary	correlate the levels of serum Cathepsin S and chromogranin A with HbA1c and eGFR in type 2 diabetic patients based on urinary Albumin- Creatinine Ratio.	Studying the correlation of the levels of serum Cathepsin S and chromogranin A with HbA1c and eGFR in type 2 diabetic patients based on urinary Albumin- Creatinine Ratio.	Baseline