Identifying early markers for diabetic kidney disease using lipid analysis.
Screening and Application Research of Early Diabetic Nephropathy Markers Based on Lipidomics.
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 |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Locations | 1 site (Hangzhou) |
| Trial ID | NCT04931537 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 20-80 with Type 2 diabetes who can commit to a five-year follow-up.
Not a fit: Patients with renal diseases from other causes or those with acute infections may not benefit from this study.
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 performed: Other studies have shown promise in identifying biomarkers for diabetic nephropathy, but this specific lipidomics approach is relatively novel.
Eligibility criteria
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 this trial is running
Hangzhou
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.