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- Klinische proef NCT00309127
Effects of Disease Management on Development of End Stage Renal Disease in Type 2 Diabetic Patients With Nephropathy
A Multicentre, Randomised Study to Examine the Effects of Disease Management on Development of End Stage Renal Disease in Type 2 Diabetic Patients With Nephropathy
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Diabetic patients consume over 10% of health care costs in most developed countries. Over 80% of these resources are used to treat diabetic complications and late stage diseases. Over 30% of patients admitted to the medical wards in Hong Kong's public hospitals have diabetes, mainly due to cardiovascular and renal complications. Diabetes is now the leading cause of end stage renal disease (ESRD), accounting for 30-50% of patients on renal replacement therapy (RRT). In Hong Kong, the number of patients receiving RRT have increased by 50% in the last 5 years but the number of patients with ESRD due to diabetes have doubled. Between 10% and 15% of patients attending medical clinics in local public hospitals either receive insulin or anti-diabetic drugs. In both community and hospital settings, between 30% and 50% of diabetic patients have albuminuria, which is by far the most powerful predictor for early mortality, cardiovascular morbidity and renal disease. Local published data show that 3-10% of diabetic patients died or developed clinical endpoints yearly.
There are now overwhelming evidence supporting the beneficial effects of optimal control of cardiovascular risk factors on clinical outcomes in diabetic patients. However, there are few studies to examine the most effective way to translate these scientific evidence collected in closely monitored clinical trial situations into daily clinical practice. Results from this multi-centre, randomized study will provide important information to health care policy makers regarding the cost effectiveness of disease management using a multidisciplinary team to deliver a structured care model in light of the growing diabetes epidemic and the constraints of finite resources and the need for equity.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Hong Kong, China
- The Chinese University of Hong Kong
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Type 2 diabetic patients with ages between 35 and 75 years (inclusive) and defined according to the 1998 WHO criteria and no history of unprovoked ketosis and not requiring continuous insulin treatment within 1 year of diagnosis
- Plasma creatinine 150-350 mmol/l (inclusive) who had no microscopic haematuria and no ultrasonographic evidence of obstructive uropathy which is amenable to surgical intervention
Exclusion Criteria:
- patients with malignancy or other life-threatening diseases
- ultrasonographic evidence of obstructive uropathy which is amenable to surgical intervention
- non-diabetes related renal disease such as glomerulonephritis proven on renal biopsy reversible kidney disease, to be ruled out by ultrasonographic examination
- patients with clinically unstable psychiatric illnesses
- Patients who have 2 consecutive values of plasma creatinine concentration which differ by more than 20% within 3 months prior to recruitment.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Death and/or ESRD defined as need for dialysis or plasma creatinine 500mmol/l
Tijdsspanne: May 2003 - Dec 2007
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May 2003 - Dec 2007
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Composite cardiovascular endpoints (acute myocardial infarction, revascularisation procedures, heart failure or unstable angina or arrhythmia requiring hospital admissions, lower extremity amputation)
Tijdsspanne: May 2003 - Dec 2007
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May 2003 - Dec 2007
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Number of hospital admissions, total number of days of hospital stay and attendance at the Accident and Emergency Department
Tijdsspanne: May 2003 - Dec 2007
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May 2003 - Dec 2007
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Juliana CN Chan, MB ChB, MD, Department of Medicine and Therapeutics, The Chinese University of Hong Kong, The Prince of Wales Hospital, Shatin
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CRE-2004.226-T
- HCPF No. 121012
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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