- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02204280
The Significance of Urine UbA52 In the Diagnosis of Diabetic Nephropathy
July 20, 2015 updated by: Hebei Medical University Third Hospital
Urine UbA52 is a Biomarker of Early Diabetic Nephropathy
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
120
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients with type 2 diabetic,diabetic with macro-or microalbuminuria and proteinuria due to nondiabetic renal disease from Hebei Medical University the Third Hospital.
Description
Inclusion Criteria:
- diabetes diagnostic criteria (WHO, 1999),age < 80 years old, gender not limited;
- diabetic with macro-or microalbuminuria;
- the subjects not took hemodialysis;
- 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:
- acute diabetic complications: ketoacidosis, hypertonic coma;
- the diagnosis of malignant tumors, particularly affecting the liver and kidney function of tumor and the application of radiation and chemotherapy treatment of patients;
- cardiac insufficiency, heart function class 3 or above;
- data is not complete, have an impact on the results;
- not hospitalized patients;
- accept long-term oral or static point methods such as steroid hormone therapy, application of renal toxicity of drugs;
- with the exception of primary kidney disease and other causes lead to eye disease;
- the combination of respiratory system infection or other systemic diseases and patients with severe primary diseases, vigorous exercise within 24 hours;
- pregnancy or breastfeeding women
- there is a clear liver disease, its alanine or aspertate aminotransferase 2 times higher than normal limit;
- reluctant to collaborators and psychiatric patients;
- has been undergoing hemodialysis.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Type 2 Diabetic
Patiens with type 2 diabetic which conform to the WHO in 1999 diabetes diagnostic criteria.
|
Diabetic With macro-or Microalbuminuria
Patients with diabetic with macro-or microalbuminuria.
|
proteinuria,nondiabetic renal disease
Patients with proteinuria due to nondiabetic renal disease,such as IgA nephropathy,FSGS,Hypertensive renal damage and MN.
|
healthy controls
Healthy person.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The urine UbA52 levels in 30 patients with type 2 diabetic mellitus,30 patients with diabetic nephropathy,30 patients with proteinuria due to nondiabetic renal disease and 30 healthy persons
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2014
Primary Completion (Actual)
July 1, 2015
Study Completion (Actual)
July 1, 2015
Study Registration Dates
First Submitted
July 23, 2014
First Submitted That Met QC Criteria
July 29, 2014
First Posted (Estimate)
July 30, 2014
Study Record Updates
Last Update Posted (Estimate)
July 21, 2015
Last Update Submitted That Met QC Criteria
July 20, 2015
Last Verified
July 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HebeiMUTH
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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