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NCT Number: NCT04931537

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

the Second Affiliated Hospital Zhejiang University Schoolof Medicine

Hangzhou, 310009, China

Location status: Recruiting

Location contact

Chao Zheng, MD. PhD

CONTACT

[email protected]

8615057585907

Yikai Zhang, PhD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Urinary Albumin Creatinine Ratio,UACR

    Time frame: 5years

    Urinary Albumin Creatinine Ratio

Study contacts

Contact information is provided by the study sponsor or research team.

Zheng Chao, MD, PhD

CONTACT

[email protected]

8615057585907

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Collaborators

  • Lishui Country People's Hospital
  • Second Affiliated Hospital of Wenzhou Medical University

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2028
First posted
Jun 18, 2021
Registry last updated
Jul 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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