Diabetic Kidney DiseaseNCT06069076
Diagnostic Value of Serum Cathepsin S and Chromogranin A in DKD
An observational study of Diabetic Kidney Disease, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Kidney Disease
- What is being tested?
- cathepsin S and chromogranin A
- How many people
- 92 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2023to 1 Oct 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with Type 2 diabetes mellitus from age 20 years to 80 years
Who may be able to join
- patients diagnosed as type 2 Diabetes mellitus
- Patients with T2DM with normoalbuminuria , microalbuminuria and macroalbuminuria.
Who cannot join
- Renal impairment of other Known origin,
- Type 1 D,
- Hepatic disease,
- Heart failure,
- Thyroid disorders,
- Autoimmune disorders,
Show all 10Show fewer
- Inflammatory condition,
- Malignancy,
- Urinary tract infection,
- Pregnancy.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Diagnostic Value of Serum Cathepsin S and Chromogranin A in Diabetic Kidney Disease
- Evulate the diagnostic value of serum cathepsin S and chromogranin A for Diabetic kidney disease.
- 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.
Read the 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.
- Conditions
- Diabetic Kidney Disease
- Being tested
- cathepsin S and chromogranin A
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cathepsin S and chromogranin ADiagnostic test
Diagnostic value of serum Cathepsin S and Chromogranin A
What is being measured
The primary outcome is the main question the study is designed to answer.
Evulate the diagnostic value of serum cathepsin S and chromogranin A for Diabetic kidney disease.
Evaluation of the clinical utility of the measurement of the level of Cathepsin S and chromogranin A in type 2 diabetic nephropathy.
Measured: Baseline
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.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start1 Nov 2023 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Z A Kamel, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06069076
- Sponsor's protocol ID
- Diabetic kidney disease
- Status last verified
- Oct 2023
- First submitted
- 29 Sep 2023
- Last updated
- 13 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 37305031Yu 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.
PubMed 35062888
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of Serum Cathepsin S and Chromogranin A in Diabetic Kidney Disease
- ClinicalTrials.gov ID
- NCT06069076
- Acronym / sponsor ID
- Diabetic kidney disease
- Conditions
- Diabetic Kidney Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 5 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Evulate the diagnostic value of serum cathepsin S and chromogranin A for Diabetic kidney disease.
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Type 2 diabetes mellitus from age 20 years to 80 years
Key inclusion criteria (2 listed)
- patients diagnosed as type 2 Diabetes mellitus
- Patients with T2DM with normoalbuminuria , microalbuminuria and macroalbuminuria.
Key exclusion criteria (10 listed)
- Renal impairment of other Known origin,
- Type 1 D,
- Hepatic disease,
- Heart failure,
- Thyroid disorders,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cathepsin S and chromogranin ADiagnostic value of serum Cathepsin S and Chromogranin A | Diagnostic test | – |
Primary outcome
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.
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
- Background: PubMed 37305031Ren 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.
- Background: PubMed 35062888Yu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Kidney Disease, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zeinab kamel (01060247896, zozet2013@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evulate the diagnostic value of serum cathepsin S and chromogranin A for Diabetic kidney disease. (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06069076, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2023.