Diabetic Kidney Disease (DKD)NCT06639529
Preliminary Study of CXCL3 As a Biomarker of Diabetic Kidney Disease
A study testing Tests of the expression of CXCL3 in various tissues in people with Diabetic Kidney Disease (DKD), run by The First Hospital of Jilin University at 1 site in China.
Trial summary
The goal of this study is to learn about CXCL3 as a biomarker for type 2 diabetic kidney disease (DKD) in adults between age of 18-80. The main question it aims to answer is: Is CXCL3 elevated in the serum or urine of type 2 adult DKD patients compared to normal control or diabetes mellitus without kidney involvement?… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Kidney Disease (DKD)
- What is being tested?
- Tests of the expression of CXCL3 in various tissues
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 10 Jun 2024to 30 Jul 2024
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Clinical and pathological diagnosis of diabetic kidney disease;
- 2. Clinical diagnosis of type 2 diabetes mellitus.
Who cannot join
- 1. Tumor;
- 2. Active infection;
- 3. Heart failure.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this study is to learn about CXCL3 as a biomarker for type 2 diabetic kidney disease (DKD) in adults between age of 18-80. The main question it aims to answer is:
- Is CXCL3 elevated in the serum or urine of type 2 adult DKD patients compared to normal control or diabetes mellitus without kidney involvement?
- Is CXCL3 elevated in the mRNA of PBMC of type 2 adult DKD patients compared to normal control or diabetes mellitus without kidney involvement?
- Is CXCL3 elevated in the kidney tissue of type 2 adult DKD patients compared to normal control or other glomerulonephritis? Participants have already been diagnosed as DKD by renal biopsy.
Read the detailed description
Diabetic kidney disease ( DKD ) has become the first cause of end-stage renal disease. The high cost of treatment brings a heavy burden to the social economy and medical insurance. However, the pathogenesis of DKD is still unclear. Because the early symptoms of DKD are hidden and difficult to diagnose, once a large amount of proteinuria occurs in clinical practice, renal damage is often difficult to reverse, and patients will soon enter ESRD. Therefore, it is of great social significance and economic benefits to clarify the pathogenesis of DKD and find more effective therapeutic targets for DKD.In our previous bioinformatics analysis, it was found that CXCL3 was significantly increased in peripheral blood PBMC of DKD, and CXCL3 was the core gene of DKD after screening by WGCNA and machine learning. CXC legend 3 ( CXCL3 ), also known as GRO gamma ( GROγ ), is a 7.9 kDa protein composed of 73 amino acids. CXCL3 is a member of the CXC subfamily of chemokines, including the \' ELR \' motif of its receptor CXCR2 tuberculosis. CXCL3 is considered to be a chemotactic factor for neutrophils, while CXCL3 has other proven roles in the field of cancer. Studies have shown that serum CXCL3 levels are associated with the progression and poor prognosis of colorectal cancer, and CXCL3 overexpression increases the malignant behavior of tumor cells, while down-regulation of its expression inhibits this phenomenon. The CXCL3 released by macrophages can promote the transformation of fibroblasts into myofibroblasts, thereby promoting the metastasis of pancreatic cancer. However, there are still few studies on CXCL3 in the kidney, and its role in DKD needs to be further explored. In the DKD single cell dataset and the KIT website, we found that CXCL3 was significantly increased in DKD, and was positively correlated with proteinuria and serum creatinine. On the basis of previous bioinformatics analysis and verification, this study further verified that the gene had no DKD damage in DKD and diabetes, the mRNA expression level of peripheral blood PBMC in normal control and the expression level in serum and urine ( Elisa ), and further verified in kidney tissue, animal and cell levels, looking for new biomarkers for DKD.
- Conditions
- Diabetic Kidney Disease (DKD)
- Being tested
- Tests of the expression of CXCL3 in various tissues
- Keywords
- CXCL3; biomarker; urine; serum; renal tissue
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tests of the expression of CXCL3 in various tissuesDiagnostic test
1.The expression of CXCL3 in peripheral blood PBMC was detected by RT-qPCR. 2.The levels of CXCL3 in serum and urine were detected by Elisa method. 3.Clinical data collection includes the patient \'s name, gender, weight, height, biochemical indicators, urine test indicators, renal biopsy data, etc. 4.The expression of CXCL3 in renal tissue was determined by immunohistochemistry.
| Study group | Role | What they receive |
|---|---|---|
| normal control | Experimental | Tests of the expression of CXCL3 in various tissues Receives: Diagnostic Test: Tests of the expression of CXCL3 in various tissues |
| diabetic mellitus | Experimental | Tests of the expression of CXCL3 in various tissues Receives: Diagnostic Test: Tests of the expression of CXCL3 in various tissues |
| diabetic kidney disease | Experimental | Tests of the expression of CXCL3 in various tissues Receives: Diagnostic Test: Tests of the expression of CXCL3 in various tissues |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum and Urine CXCL3 level by Enzyme linked immunosorbent assay (Elisa)
Serum and Urine samples were thawed and subjected to centrifugation. Thereafter, the levels of CXCL3 were determined using a sandwich ELISA kit.
Measured: From enrollment to the end of experiment at 4 weeks
Secondary outcomes (1)
Immunohistochemistry and immunofluorescence of CXCL3 in kidney tissue
The kidney tissues of DKD patients and normal/disease controls were fixed in formalin and then paraffin-embedded to prepare renal sections. The prepared renal section was stained with CXCL3 antibody, and images were captured using an Olympus cellSens Entry microscopy system.
Measured: From enrollment to the end of experiment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start10 Jun 2024
- Primary completion30 Jul 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Kidney Disease (DKD)Studies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06639529
- Sponsor's protocol ID
- 2024-695
- Status last verified
- Jun 2024
- First submitted
- 7 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The primary concern is the protection of participant privacy. Even with anonymization techniques, there is a risk of re-identification, particularly in studies involving rare diseases or specific populations. Participants trust researchers to safeguard their personal information, and any breach of this trust could have serious implications for their well-being. Maintaining confidentiality is not only an ethical obligation but also a legal one, as regulations such as the Health Insurance Portability and Accountability Act (HIPAA) in the United States mandate strict guidelines for handling sensitive health information. Sharing individual participant data without proper context can lead to misinterpretation and misuse of the data. Researchers or stakeholders who are not involved in the study may draw erroneous conclusions or apply the findings inappropriately. This misinterpretation can undermine the credibility of the research and could potentially lead to harmful consequences for patien
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Study of CXCL3 As a Biomarker of Diabetic Kidney Disease
- ClinicalTrials.gov ID
- NCT06639529
- Acronym / sponsor ID
- 2024-695
- Conditions
- Diabetic Kidney Disease (DKD)
- Keywords
- CXCL3; biomarker; urine; serum; renal tissue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 15 Oct 2024 (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.
The goal of this study is to learn about CXCL3 as a biomarker for type 2 diabetic kidney disease (DKD) in adults between age of 18-80. The main question it aims to answer is:
- Is CXCL3 elevated in the serum or urine of type 2 adult DKD patients compared to normal control or diabetes mellitus without kidney involvement?
- Is CXCL3 elevated in the mRNA of PBMC of type 2 adult DKD patients compared to normal control or diabetes mellitus without kidney involvement?
- Is CXCL3 elevated in the kidney tissue of type 2 adult DKD patients compared to normal control or other glomerulonephritis? Participants have already been diagnosed as DKD by renal biopsy.
Detailed description
Diabetic kidney disease ( DKD ) has become the first cause of end-stage renal disease. The high cost of treatment brings a heavy burden to the social economy and medical insurance. However, the pathogenesis of DKD is still unclear. Because the early symptoms of DKD are hidden and difficult to diagnose, once a large amount of proteinuria occurs in clinical practice, renal damage is often difficult to reverse, and patients will soon enter ESRD. Therefore, it is of great social significance and economic benefits to clarify the pathogenesis of DKD and find more effective therapeutic targets for DKD.In our previous bioinformatics analysis, it was found that CXCL3 was significantly increased in peripheral blood PBMC of DKD, and CXCL3 was the core gene of DKD after screening by WGCNA and machine learning. CXC legend 3 ( CXCL3 ), also known as GRO gamma ( GROγ ), is a 7.9 kDa protein composed of 73 amino acids. CXCL3 is a member of the CXC subfamily of chemokines, including the \' ELR \' motif of its receptor CXCR2 tuberculosis. CXCL3 is considered to be a chemotactic factor for neutrophils, while CXCL3 has other proven roles in the field of cancer. Studies have shown that serum CXCL3 levels are associated with the progression and poor prognosis of colorectal cancer, and CXCL3 overexpression increases the malignant behavior of tumor cells, while down-regulation of its expression inhibits this phenomenon. The CXCL3 released by macrophages can promote the transformation of fibroblasts into myofibroblasts, thereby promoting the metastasis of pancreatic cancer. However, there are still few studies on CXCL3 in the kidney, and its role in DKD needs to be further explored. In the DKD single cell dataset and the KIT website, we found that CXCL3 was significantly increased in DKD, and was positively correlated with proteinuria and serum creatinine. On the basis of previous bioinformatics analysis and verification, this study further verified that the gene had no DKD damage in DKD and diabetes, the mRNA expression level of peripheral blood PBMC in normal control and the expression level in serum and urine ( Elisa ), and further verified in kidney tissue, animal and cell levels, looking for new biomarkers for DKD.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| normal control | Experimental | Diagnostic Test: Tests of the expression of CXCL3 in various tissuesTests of the expression of CXCL3 in various tissues |
| diabetic mellitus | Experimental | Diagnostic Test: Tests of the expression of CXCL3 in various tissuesTests of the expression of CXCL3 in various tissues |
| diabetic kidney disease | Experimental | Diagnostic Test: Tests of the expression of CXCL3 in various tissuesTests of the expression of CXCL3 in various tissues |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1. Clinical and pathological diagnosis of diabetic kidney disease;
- 2. Clinical diagnosis of type 2 diabetes mellitus.
Key exclusion criteria (3 listed)
- 1. Tumor;
- 2. Active infection;
- 3. Heart failure.
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 |
|---|---|---|
| Tests of the expression of CXCL3 in various tissues1.The expression of CXCL3 in peripheral blood PBMC was detected by RT-qPCR. 2.The levels of CXCL3 in serum and urine were detected by Elisa method. 3.Clinical data collection includes the patient \'s name, gender, weight, height, biochemical indicators, urine test indicators, renal biopsy data, etc. 4.The expression of CXCL3 in renal tissue was determined by immunohistochemistry. | Diagnostic test | diabetic kidney disease, diabetic mellitus, normal control |
Primary outcome
Serum and Urine CXCL3 level by Enzyme linked immunosorbent assay (Elisa)
Time frame: From enrollment to the end of experiment at 4 weeks
Serum and Urine samples were thawed and subjected to centrifugation. Thereafter, the levels of CXCL3 were determined using a sandwich ELISA kit.
1 secondary outcome
Immunohistochemistry and immunofluorescence of CXCL3 in kidney tissue
Time frame: From enrollment to the end of experiment at 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: No. The primary concern is the protection of participant privacy. Even with anonymization techniques, there is a risk of re-identification, particularly in studies involving rare diseases or specific populations. Participants trust researchers to safeguard their personal information, and any breach of this trust could have serious implications for their well-being. Maintaining confidentiality is not only an ethical obligation but also a legal one, as regulations such as the Health Insurance Portability and Accountability Act (HIPAA) in the United States mandate strict guidelines for handling sensitive health information. Sharing individual participant data without proper context can lead to misinterpretation and misuse of the data. Researchers or stakeholders who are not involved in the study may draw erroneous conclusions or apply the findings inappropriately. This misinterpretation can undermine the credibility of the research and could potentially lead to harmful consequences for patien
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tests of the expression of CXCL3 in various tissues in people with Diabetic Kidney Disease (DKD), run by The First Hospital of Jilin University at 1 site in China.
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 3 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: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum and Urine CXCL3 level by Enzyme linked immunosorbent assay (Elisa) (time frame: From enrollment to the end of experiment at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2024.