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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04976426
• Other study ID #: zhengchao3
• Status: Not yet recruiting
• Start date: January 1, 2022
• Est. completion date: December 31, 2026

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
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Biomarkers
• Diabetes Mellitus
• Diabetic Kidney Disease
• Diabetic Nephropathies
• Early Diagnosis
• Kidney Diseases

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University	Lishui Country People's Hospital, Second Affiliated Hospital of Wenzhou Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	multidimensional network biomarkers	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.	5years