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

NCT04931537 | Recruiting DMC

• 1 other identifier: zhengchao-2
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetic Nephropathy Type 2; Biomarker

Keywords

Diabetic Nephropathy Type 2; Metabonomics

Outcome Measures

Primary Outcomes (1)

• Urinary Albumin Creatinine Ratio，UACR

  Urinary Albumin Creatinine Ratio

  5years

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects were 20-80 years old and of either gender

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• Second Affiliated Hospital of Wenzhou Medical University: collaborator
• Lishui Country People's Hospital: collaborator

Study Sites (1)

the Second Affiliated Hospital Zhejiang University Schoolof Medicine

Hangzhou, 310009, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, plasma and urine samples were collected for serological and metabolomic studies

Study Officials

• Chao Zheng, MD,PhD

  the Second Affiliated Hospital Zhejiang University Schoolof Medicine

  PRINCIPAL INVESTIGATOR

• Yikai Zhang, PhD

  the Second Affiliated Hospital Zhejiang University Schoolof Medicine

  STUDY DIRECTOR

Central Study Contacts

Zheng Chao, MD, PhD

CONTACT

8615057585907; wallbb_1022@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: June 18, 2021
• Study Start: May 1, 2021
• Primary Completion: December 31, 2023
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 20, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)