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NCT Number: NCT06069076

Diagnostic Value of Serum Cathepsin S and Chromogranin A in DKD

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

cathepsin S and chromogranin A

Diagnostic Test

Diagnostic value of serum Cathepsin S and Chromogranin A

Primary outcomes

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

    Time frame: Baseline

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

Secondary outcomes

  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.

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Zeinab kamel

CONTACT

[email protected]

01060247896

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Oct 5, 2023
Registry last updated
Oct 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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