Diagnostic Value of Serum Cathepsin S and Chromogranin A in DKD

October 12, 2023 updated by: Z A Kamel, Assiut University

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

  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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

92

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients with Type 2 diabetes mellitus from age 20 years to 80 years

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2023

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

September 29, 2023

First Submitted That Met QC Criteria

September 29, 2023

First Posted (Actual)

October 5, 2023

Study Record Updates

Last Update Posted (Actual)

October 13, 2023

Last Update Submitted That Met QC Criteria

October 12, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Diabetic kidney disease

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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