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Recruiting NCT04931537

Screening and Application Research of Early Diabetic Nephropathy Markers Based on Lipidomics.

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Trial Parameters

Condition Diabetic Nephropathy Type 2
Sponsor Second Affiliated Hospital, School of Medicine, Zhejiang University
Study Type OBSERVATIONAL
Phase N/A
Enrollment 1,000
Sex ALL
Min Age 18 Years
Max Age 80 Years
Start Date 2021-05-01
Completion 2023-12-31

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Brief Summary

Diabetic nephropathy (DN) is one of the major microvascular complications associated with diabetic patients, and also the major global cause of chronic kidney disease and end-stage renal disease (ESRD). Albuminuria and estimated glomerular filtration rate (eGFR) are currently recognized clinical indicators for early diagnosis of DN, however, the sensitivity and specificity are unsatisfactory. The early identification and treatment of DKD are conducive to lowering the risk of kidney damage by as much as 50%. Therefore, it is particularly critical to find new biomarkers to reflect the potential DKD lesions in the clinical silent period earlier and more accurately. Therefore, this study intends to analyze the differentially expressed lipids in early DKD, T2DM and healthy adults by mass spectrometry, and verify the related results by larger samples, so as to screen out early markers of DKD and achieve the ultimate goal of clinical application.

Eligibility 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.

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