Diagnostic Value of Serum Cathepsin S and Chromogranin A in DKD

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

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

Вторичные конечные точки (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. [Срок оценки: Baseline]

Критерии участия

Критерии включения

• patients diagnosed as type 2 Diabetes mellitus
• Patients with T2DM with normoalbuminuria , microalbuminuria and macroalbuminuria.

Критерии исключения

• Renal impairment of other Known origin,
• Type 1 D,
• Hepatic disease,
• Heart failure,
• Thyroid disorders,
• Autoimmune disorders,
• Inflammatory condition,
• Malignancy,
• Urinary tract infection,
• Pregnancy.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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

Идентификаторы

NCT: NCT06069076 · Diabetic kidney disease

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗