Diagnostic Value of Serum Cathepsin S and Chromogranin A in DKD

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06069076
Collaborator
(none)
92
36

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: cathepsin S and chromogranin A

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
92 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Diagnostic Value of Serum Cathepsin S and Chromogranin A in Diabetic Kidney Disease
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2025
Anticipated Study Completion Date :
Oct 1, 2026

Outcome Measures

Primary Outcome Measures

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

    Evaluation of the clinical utility of the measurement of the level of Cathepsin S and chromogranin A in type 2 diabetic nephropathy.

Secondary Outcome Measures

  1. 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. [Baseline]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Z A Kamel, principal investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT06069076
Other Study ID Numbers:
  • Diabetic kidney disease
First Posted:
Oct 5, 2023
Last Update Posted:
Oct 6, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 6, 2023