Establishment and Clinical Validation of a New Technique for Early Diagnosis of Diabetic Nephropathy
1 other identifier
observational
1,000
0 countries
N/A
Brief Summary
Diabetic kidney disease(DKD) is a leading cause of chronic kidney disease and end-stage renal disease across the world. Early identification of DKD is vitally important for the effective prevention and control of it. However, the available indicators are doubtful in the early diagnosis of DKD. This study aims to develop a novel system of multidimensional network biomarkers (MDNBs) to estimating early diabetic nephropathy, and further validating the performance of the novel systemin in prediction of the risk for early diabetic nephropathy by a nested case-control study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2022
Longer than P75 for all trials
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
First Submitted
Initial submission to the registry
June 24, 2021
CompletedFirst Posted
Study publicly available on registry
July 26, 2021
CompletedStudy Start
First participant enrolled
January 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
ExpectedJuly 26, 2021
June 1, 2021
2 years
June 24, 2021
July 14, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
multidimensional network biomarkers
a novel system of multidimensional network biomarkers (MDNBs) based on a widely targeted metabolomics. Our previous study demonstrated that the combination of Linolelaidic Acid (C18:2N6T), L-Dihydroorotic Acid, and Azoxystrobin Acid might serve as a potential multidimensional network biomarkers of DKD. So we create a panel of MDNBs containing these biomakers as primary outcome measure.
5years
Eligibility Criteria
The diagnosis of T2DM in our study complied with the criteria set out by the American Diabetes Association. The inclusion criteria are as follows: for all patients diagnosed with T2DM without CKD. After five years of following up，participants were recruited and then divided into two groups: T2DM group without nephropathy(non-DKD, UACR urinary albumin/creatinine ratio \< 3 mg/mmol) and DKD group with microalbuminuria and macroalbuminuria (DKD, UACR \> 3 mg/mmol)
You may qualify if:
- Subjects who have signed informed consent.
- Subjects who were diagnosed with diabetes at least 5 years.
- Subjects showed good compliance, and the follow-up data was available for \>5 years.
You may not qualify if:
- Renal diseases caused by other causes, including primary and secondary;
- All kinds of acute infections;
- The expected life expectancy (life expectancy or related diseases) was less than 5 years according to the researcher's judgment.
- Drug users or drug abusers;
- Sexually transmitted diseases such as viral hepatitis, AIDS and syphilis, and infectious diseases such as tuberculosis are in an active period;
- Any situation judged by the researcher that affects enrollment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zheng Chao, MD, PhD
the Second Affiliated Hospital Zhejiang University Schoolof Medicine
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2021
First Posted
July 26, 2021
Study Start
January 1, 2022
Primary Completion
December 31, 2023
Study Completion (Estimated)
December 31, 2026
Last Updated
July 26, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share