The Significance of Urine UbA52 In the Diagnosis of Diabetic Nephropathy

NCT ID: NCT02204280

Last Updated: 2015-07-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2015-07-31

Brief Summary

Definite diagnosis of diabetic nephropathy is currently based on renal biopsy findings. In most cases, however, the diagnosis can be reliably made in patients with macroalbuminuria in the presence of diabetic retinopathy.Microalbuminuria is often used as a prognostic marker in type 1 diabetes, because approximately 50% of type 1 diabetes patients with microalbuminuria will eventually develop diabetic nephropathy. Conversely, microalbu- minuria is of much less value as a marker in DM because it has a variety of causes, including hypertension. Thus, additional markers are needed to identify patient groups with a high risk of developing overt diabetic nephropathy. The aims of this study is checking urine UbA52 levels with ELISA to identify its significance in the diagnosis of diabetic nephropathy.

Detailed Description

It is now well recognized that the incidence of diabetes is increasing worldwide. It is the leading cause of end-stage renal disease (ESRD) in Western countries. Diabetic nephropathy has been reported to occur in 25%-40% of people with diabetes. The appearance of microalbuminuria usually is regarded as incipient nephropathy, but recently, work has suggested that some individuals with diabetes and decreased GFR may not have an increased urinary AER.Identification of markers for prediction of the clinical course of diabetic nephropathy remains a major challenge. Previous research showed that m/z14766 protein by mass spectrometry, was selectively excreted in the urine of diabetic nephropathy patients, the m/z 14766 mass peaks were identified as UbA52. We suppose that UbA52 can be regard as a simple and practical biomarker for diagnosis of diabetic nephropathy.

Conditions

Diabetic Nephropathy

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Type 2 Diabetic

Patiens with type 2 diabetic which conform to the WHO in 1999 diabetes diagnostic criteria.

No interventions assigned to this group

Diabetic With macro-or Microalbuminuria

Patients with diabetic with macro-or microalbuminuria.

No interventions assigned to this group

proteinuria,nondiabetic renal disease

Patients with proteinuria due to nondiabetic renal disease,such as IgA nephropathy,FSGS,Hypertensive renal damage and MN.

No interventions assigned to this group

healthy controls

Healthy person.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. diabetes diagnostic criteria (WHO, 1999),age < 80 years old, gender not limited;

2. diabetic with macro-or microalbuminuria;

3. the subjects not took hemodialysis;

4. with proteinuria due to nondiabetic renal disease :Hypertensive renal damage,drug-induced acute interstitial nephritis, IgA, primary membranous nephropathy,FSGS or MCD, which were confirmed by renal biopsy.

Exclusion Criteria

1. acute diabetic complications: ketoacidosis, hypertonic coma;

2. the diagnosis of malignant tumors, particularly affecting the liver and kidney function of tumor and the application of radiation and chemotherapy treatment of patients;

3. cardiac insufficiency, heart function class 3 or above;

4. data is not complete, have an impact on the results;

5. not hospitalized patients;

6. accept long-term oral or static point methods such as steroid hormone therapy, application of renal toxicity of drugs;

7. with the exception of primary kidney disease and other causes lead to eye disease;

8. the combination of respiratory system infection or other systemic diseases and patients with severe primary diseases, vigorous exercise within 24 hours;

9. pregnancy or breastfeeding women

10. there is a clear liver disease, its alanine or aspertate aminotransferase 2 times higher than normal limit;

11. reluctant to collaborators and psychiatric patients;

12. has been undergoing hemodialysis.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role: collaborator

Hebei Medical University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Xu X, Dong Y, Liu M, Li Y, Zhang Y. Clinical significance of UbA52 level in the urine of patients with type 2 diabetes mellitus and diabetic kidney disease. Nefrologia (Engl Ed). 2021 Sep-Oct;41(5):548-555. doi: 10.1016/j.nefroe.2021.11.009.

Reference Type: DERIVED

PMID: 36165137 (View on PubMed)

Other Identifiers

HebeiMUTH

Identifier Type: -

Identifier Source: org_study_id