- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02204280
The Significance of Urine UbA52 In the Diagnosis of Diabetic Nephropathy
20. juli 2015 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
120
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 70 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
patients with type 2 diabetic,diabetic with macro-or microalbuminuria and proteinuria due to nondiabetic renal disease from Hebei Medical University the Third Hospital.
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
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
Tidsramme: 12 months
|
12 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Publikationer og nyttige links
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Datoer for undersøgelser
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Studer store datoer
Studiestart
1. august 2014
Primær færdiggørelse (Faktiske)
1. juli 2015
Studieafslutning (Faktiske)
1. juli 2015
Datoer for studieregistrering
Først indsendt
23. juli 2014
Først indsendt, der opfyldte QC-kriterier
29. juli 2014
Først opslået (Skøn)
30. juli 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
21. juli 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. juli 2015
Sidst verificeret
1. juli 2014
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- HebeiMUTH
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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