Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04931537 |
| Other study ID # |
zhengchao-2 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2021 |
| Est. completion date |
December 31, 2028 |
Study information
| Verified date |
June 2021 |
| Source |
Second Affiliated Hospital, School of Medicine, Zhejiang University |
| Contact |
Zheng Chao, MD, PhD |
| Phone |
8615057585907 |
| Email |
wallbb_1022[@]163.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
Description:
The present study was a scientific research project concurrently conducted by clinical and
laboratory. In term of clinical research, the basic personal data, medical history, physical
examination and auxiliary examination results of subjects were mainly recorded. Whereas in
term of basic research, the serum, plasma and urine samples of patients were collected for
serological and metabonomics research to find new biomarkers.
First, we recruited the patients who met the inclusion criteria. The patients' serum, plasma
and urine were collected at baseline after obtaining informed patient consent.
Simultaneously, the basic information, anthropometric indicators (including height, weight,
waist circumference, hip circumference, blood pressure), past history, family history,
menstrual history, birth history, medication history, lifestyle of the patients were
registered, and the corresponding laboratory examination and auxiliary examination were
carried out according to the diagnostic process. All data and data were entered into the
database for later analysis. After the initial diagnosis, the patients were enrolled in the
current trial. The patients were followed up annually until the last follow-up visit, and the
complete follow-up was conducted for at least 5 years. Each follow-up followed the principles
of routine clinical diagnosis and treatment. In addition, the patients' serum, plasma and
urine samples were collected once a year during follow-up, and a centralized test of
glycosylated hemoglobin was performed once a year.
In this study, the pathogenesis of type 2 diabetic nephropathy was explored through
multi-center standardized clinical follow-up; The potential mechanism and possible biomarkers
in patients with early renal diseases of type 2 diabetes was explored through prospective
long-term follow-up, so as to find novel therapeutic approaches and suitable population.
