Clinical trial Recruiting at 1 site Observational Ages 18 to 80

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 typeObservational
Ages18 Years to 80 Years
SexAll
Enrollment1000 (estimated)
SponsorSecond Affiliated Hospital, Zhejiang University, School of Medicine
Academic / other
Locations1 site (Hangzhou)
StatusRecruiting
StartedMay 1, 2021
Main results expectedDecember 31, 2023
Study endsDecember 31, 2028
Registry record updatedJuly 20, 2021
Trial IDNCT04931537 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

  • 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

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.