Clinical Trials Directory

Trials / Completed

CompletedNCT02204280

The Significance of Urine UbA52 In the Diagnosis of Diabetic Nephropathy

Urine UbA52 is a Biomarker of Early Diabetic Nephropathy

Status
Completed
Phase
Study type
Observational
Enrollment
120 (actual)
Sponsor
Hebei Medical University Third Hospital · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

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

Timeline

Start date
2014-08-01
Primary completion
2015-07-01
Completion
2015-07-01
First posted
2014-07-30
Last updated
2015-07-21

Source: ClinicalTrials.gov record NCT02204280. Inclusion in this directory is not an endorsement.