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.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetes Mellitus; Diabetic Kidney Disease; Biomarkers; Early Diagnosis

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Zheng Chao, MD, PhD; Phone Number: 8615057585907; Email: wallbb_1022@163.com
• Study Contact Backup: Name: Yikai Zhang, PhD; Phone Number: 8613706673733; Email: smt198853@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study 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)

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Collaborators: Second Affiliated Hospital of Wenzhou Medical University; Lishui Country People's Hospital
• Investigators: Principal Investigator: Zheng Chao, MD, PhD, the Second Affiliated Hospital Zhejiang University Schoolof Medicine

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2022
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2026

Study Registration Dates

• First Submitted: June 24, 2021
• First Submitted That Met QC Criteria: July 14, 2021
• First Posted (Actual): July 26, 2021

Study Record Updates

• Last Update Posted (Actual): July 26, 2021
• Last Update Submitted That Met QC Criteria: July 14, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Kidney Diseases; Disease; Diabetic Nephropathies
• Other Study ID Numbers: zhengchao3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No