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临床试验/NCT04931537
NCT04931537招募中不适用

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

Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2021年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,000
试验地点
1
主要终点
Urinary Albumin Creatinine Ratio,UACR

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects who have signed informed consent.
  • Subjects were 20-80 years old and of either gender.
  • Subjects showed good compliance, and the follow-up data was available for >5 years.

排除标准

  • Meet the 1999 World Health Organization (WHO) diagnostic criteria for T1DM、T2DM;
  • Renal diseases caused by other causes, including primary and secondary;
  • All kinds of acute infections;
  • The expected life expectancy (life expectancy or related diseases) was less than 5 years according to the researcher's judgment.
  • Drug users or drug abusers;
  • Sexually transmitted diseases such as viral hepatitis, AIDS and syphilis, and infectious diseases such as tuberculosis are in an active period;
  • Any situation judged by the researcher that affects enrollment.

结局指标

主要结局

Urinary Albumin Creatinine Ratio,UACR

时间窗: 5years

Urinary Albumin Creatinine Ratio

次要结局

未报告次要终点

研究者

发起方
Second Affiliated Hospital, School of Medicine, Zhejiang University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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