Preliminary Study of CXCL3 As a Biomarker of Diabetic Kidney Disease
October 10, 2024 updated by: The First Hospital of Jilin University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jilin
-
Changchun, Jilin, China, 130021
- The First hospital of Jilin University
-
-
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
Description
Inclusion Criteria:
- 1. Clinical and pathological diagnosis of diabetic kidney disease;
- 2. Clinical diagnosis of type 2 diabetes mellitus.
Exclusion Criteria:
- 1. Tumor;
- 2. Active infection;
- 3. Heart failure.
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
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: normal control
Tests of the expression of CXCL3 in various tissues
|
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.
|
|
Experimental: diabetic mellitus
Tests of the expression of CXCL3 in various tissues
|
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.
|
|
Experimental: diabetic kidney disease
Tests of the expression of CXCL3 in various tissues
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
From enrollment to the end of experiment at 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Immunohistochemistry and immunofluorescence of CXCL3 in kidney tissue
Time Frame: From enrollment to the end of experiment at 8 weeks
|
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.
|
From enrollment to the end of experiment at 8 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
mRNA level of CXCL3 in PBMC
Time Frame: From enrollment to the end of experiment at 4 weeks
|
Total RNA was isolated from these cells using a Total RNA Isolation Kit, RT-qPCR of PBMC in DKD and normal controls was conducted using 2× Q3 SYBR qPCR Master mix.
|
From enrollment to the end of experiment at 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (Actual)
June 10, 2024
Primary Completion (Actual)
July 30, 2024
Study Completion (Actual)
July 30, 2024
Study Registration Dates
First Submitted
October 7, 2024
First Submitted That Met QC Criteria
October 10, 2024
First Posted (Actual)
October 15, 2024
Study Record Updates
Last Update Posted (Actual)
October 15, 2024
Last Update Submitted That Met QC Criteria
October 10, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-695
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
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
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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.