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NCT Number: NCT04976426

Establishment and Clinical Validation of a New Technique for Early Diagnosis of Diabetic Nephropathy

Diabetic kidney disease(DKD) is a leading cause of chronic kidney disease and end-stage renal disease across the world. Early identification of DKD is vitally important for the effective prevention and control of it. However, the available indicators are doubtful in the early diagnosis of DKD. This study aims to develop a novel system of multidimensional network biomarkers (MDNBs) to estimating early diabetic nephropathy, and further validating the performance of the novel systemin in prediction of the risk for early diabetic nephropathy by a nested case-control study.

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Key information

About this study

Patients with a history of more than 5 years of diabetes without DKD were recruited. At the baseline visit, the patients' serum, plasma and urine were collected 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 5years of follow up, subjects will be divided into two groups(the new onset DKD group and the non-DKD group), the base line level of MDNBs were tested in the two group to validate the performance of the novel MDNBs in in prediction of the risk for early diabetic nephropathy.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects who have signed informed consent.
  • Subjects who were diagnosed with diabetes at least 5 years.
  • Subjects showed good compliance, and the follow-up data was available for >5 years.

Exclusion criteria

  • 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. multidimensional network biomarkers

    Time frame: 5years

    a novel system of multidimensional network biomarkers (MDNBs) based on a widely targeted metabolomics. Our previous study demonstrated that the combination of Linolelaidic Acid (C18:2N6T), L-Dihydroorotic Acid, and Azoxystrobin Acid might serve as a potential multidimensional network biomarkers of DKD. So we create a panel of MDNBs containing these biomakers as primary outcome measure.

Study contacts

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

Yikai Zhang, PhD

CONTACT

[email protected]

8613706673733

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
2022
Primary completion
2023
Study completion
2026
First posted
Jul 26, 2021
Registry last updated
Jul 26, 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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