NCT06639529

Brief 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?
  • 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 10, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 7, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
Last Updated

October 15, 2024

Status Verified

June 1, 2024

Enrollment Period

2 months

First QC Date

October 7, 2024

Last Update Submit

October 10, 2024

Conditions

Diabetic Kidney Disease (DKD)

Keywords

CXCL3; biomarker; urine; serum; renal tissue

Outcome Measures

Primary Outcomes (1)

  • 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.

    From enrollment to the end of experiment at 4 weeks

Secondary Outcomes (1)

  • Immunohistochemistry and immunofluorescence of CXCL3 in kidney tissue

    From enrollment to the end of experiment at 8 weeks

Other Outcomes (1)

  • mRNA level of CXCL3 in PBMC

    From enrollment to the end of experiment at 4 weeks

Study Arms (3)

normal control

EXPERIMENTAL

Tests of the expression of CXCL3 in various tissues

Diagnostic Test: Tests of the expression of CXCL3 in various tissues

diabetic mellitus

EXPERIMENTAL

Tests of the expression of CXCL3 in various tissues

Diagnostic Test: Tests of the expression of CXCL3 in various tissues

diabetic kidney disease

EXPERIMENTAL

Tests of the expression of CXCL3 in various tissues

Diagnostic Test: Tests of the expression of CXCL3 in various tissues

Interventions

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.

diabetic kidney diseasediabetic mellitusnormal control

Eligibility Criteria

Age18 Years - 80 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Clinical and pathological diagnosis of diabetic kidney disease;
  • \. Clinical diagnosis of type 2 diabetes mellitus.

You may not qualify if:

  • \. Tumor;
  • \. Active infection;
  • \. Heart failure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

MeSH Terms

Conditions

Diabetic Nephropathies

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2024

First Posted

October 15, 2024

Study Start

June 10, 2024

Primary Completion

July 30, 2024

Study Completion

July 30, 2024

Last Updated

October 15, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

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

Locations

CN(1)