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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20-80
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial population

The diagnosis of T2DM in our study complied with the criteria set out by the American Diabetes Association. The inclusion criteria are as follows: for all patients diagnosed with T2DM without CKD. After five years of following up,participants were recruited and then divided into two groups: T2DM group without nephropathy(non-DKD, UACR urinary albumin/creatinine ratio \< 3 mg/mmol) and DKD group with microalbuminuria and macroalbuminuria (DKD, UACR \> 3 mg/mmol)

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
5years

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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Second Affiliated Hospital, School of Medicine, Zhejiang University

Lead sponsor

Second Affiliated Hospital of Wenzhou Medical University

Collaborator

Lishui Country People's Hospital

Collaborator

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