Diagnostic Value of Serum Cathepsin S and Chromogranin A in DKD

NCT ID: NCT06069076

Last Updated: 2023-10-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 92 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2026-10-01

Brief 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.

Detailed 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.

Conditions

Diabetic Kidney Disease

Study Design

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

Interventions

cathepsin S and chromogranin A

Diagnostic value of serum Cathepsin S and Chromogranin A

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Z A Kamel

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Zeinab kamel

Role: CONTACT

zozet2013@yahoo.com

01060247896

References

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.

Reference Type: BACKGROUND

PMID: 37305031 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35062888 (View on PubMed)

Other Identifiers

Diabetic kidney disease

Identifier Type: -

Identifier Source: org_study_id