Menu
Not yet recruiting NCT06069076

Diagnostic Value of Serum Cathepsin S and Chromogranin A in DKD

— Observational Diabetic Kidney Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: cathepsin S and chromogranin A.
Who it may be relevant to
Registry conditions: Diabetic Kidney Disease. Basic parameters: 20 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Evulate the diagnostic value of serum cathepsin S and chromogranin A for Diabetic kidney disease. [Time frame: Baseline]
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. [Time frame: Baseline]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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. PMID 37305031
  • 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. PMID 35062888

Identifiers

NCT: NCT06069076 · Diabetic kidney disease

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗