Diabetic NephropathyNCT02204280
The Significance of Urine UbA52 In the Diagnosis of Diabetic Nephropathy
An observational study of Diabetic Nephropathy, run by Hebei Medical University Third Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetic Nephropathy
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Aug 2014to Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
About this study
Official title: 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.
Read the 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
- Keywords
- UbA52;diabetic nephropathy ;diabetic;ELISA
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2014 (estimated)
- Study startAug 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic NephropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sixth Affiliated Hospital, Sun Yat-sen University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02204280
- Sponsor's protocol ID
- HebeiMUTH
- Status last verified
- Jul 2014
- First submitted
- 23 Jul 2014
- Last updated
- 21 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 36165137
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urine UbA52 is a Biomarker of Early Diabetic Nephropathy
- ClinicalTrials.gov ID
- NCT02204280
- Acronym / sponsor ID
- HebeiMUTH
- Conditions
- Diabetic Nephropathy
- Keywords
- UbA52;diabetic nephropathy ;diabetic;ELISA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Hebei Medical University Third HospitalUniversity, hospital or other
- Collaborators
- Sixth Affiliated Hospital, Sun Yat-sen University
- Study start
- Aug 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 30 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2015.
- Derived from this study: PubMed 36165137Xu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Nephropathy, run by Hebei Medical University Third Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02204280, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2015.