Identifying early markers for diabetic kidney disease using lipid analysis.
Official title: Screening and Application Research of Early Diabetic Nephropathy Markers Based on Lipidomics.
Run by Second Affiliated Hospital, Zhejiang University, School of Medicine · NCT04931537 · Data updated 2026-11-12
This study is trying to find early signs of kidney damage in people with Type 2 diabetes by looking at fat levels in their blood and urine over several years.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | Second Affiliated Hospital, Zhejiang University, School of Medicine Academic / other |
| Locations | 1 site (Hangzhou) |
| Status | Recruiting |
| Started | May 1, 2021 |
| Main results expected | December 31, 2023 |
| Study ends | December 31, 2028 |
| Registry record updated | July 20, 2021 |
| Trial ID | NCT04931537 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals aged 20-80 with Type 2 diabetes who can commit to a five-year follow-up.
✕Probably not a fit
Patients with renal diseases from other causes or those with acute infections may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to identify new biomarkers for early diabetic nephropathy (DN) by analyzing lipid profiles in serum, plasma, and urine samples from patients with Type 2 diabetes and healthy individuals. Participants aged 20-80 will be recruited, and their medical history, physical examinations, and laboratory results will be documented. Samples will be collected at baseline and annually for at least five years to track changes and identify potential early indicators of kidney damage. The goal is to improve the sensitivity and specificity of early diagnosis of diabetic kidney disease.
Why it matters
Potential benefit: If successful, this study could lead to earlier and more accurate detection of diabetic nephropathy, potentially reducing the risk of severe kidney damage.
How similar studies have gone: Other studies have shown promise in identifying biomarkers for diabetic nephropathy, but this specific lipidomics approach is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Subjects who have signed informed consent. 2. Subjects were 20-80 years old and of either gender. 3. Subjects showed good compliance, and the follow-up data was available for \>5 years. Exclusion Criteria: 1. Meet the 1999 World Health Organization (WHO) diagnostic criteria for T1DM、T2DM; 2. Renal diseases caused by other causes, including primary and secondary; 3. All kinds of acute infections; 4. The expected life expectancy (life expectancy or related diseases) was less than 5 years according to the researcher's judgment. 5. Drug users or drug abusers; 6. Sexually transmitted diseases such as viral hepatitis, AIDS and syphilis, and infectious diseases such as tuberculosis are in an active period; 7. Any situation judged by the researcher that affects enrollment.
Where it's running
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the Second Affiliated Hospital Zhejiang University Schoolof Medicine
Hangzhou, China Recruiting
Study contacts
- Principal investigator: Chao Zheng, MD,PhD — the Second Affiliated Hospital Zhejiang University Schoolof Medicine
- Study coordinator: Zheng Chao, MD, PhD
- Email: wallbb_1022@163.com
- Phone: 8615057585907
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Umbilical cord stem cell injection into the kidney for people with diabetic kidney disease.
This trial will try a single intra-renal injection of umbilical cord–derived mesenchymal stem cells to see if it is safe and helps adults aged 40–65 with diabetic nephropathy.
-
Using a genetic test to manage heart and kidney complications in type 2 diabetes
This study is testing if a genetic test can help doctors better manage heart and kidney problems in people with type 2 diabetes by personalizing their treatment based on their genetic risk.
-
New methods for diagnosing and treating type 2 diabetes nephropathy
This study is testing new ways to diagnose and treat kidney problems in people with type 2 diabetes by using advanced tools and combining different medical approaches.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.