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Effects of Disease Management on Development of End Stage Renal Disease in Type 2 Diabetic Patients With Nephropathy

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ClinicalTrials.gov Identifier: NCT00309127
Recruitment Status : Completed
First Posted : March 31, 2006
Last Update Posted : August 24, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Disease management using a multidisciplinary team to achieve and maintain optimal metabolic and cardiovascular risk factors control in Type 2 diabetic patients with nephropathy reduces the incidence of end stage renal disease (ESRD) and improves clinical outcomes compared to usual clinic-based care

Condition or disease Intervention/treatment
Type 2 Diabetes Mellitus DM Nephropathy Behavioral: Multidisciplinary team care

Detailed Description:

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 205 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2003
Primary Completion Date : December 2007
Study Completion Date : December 2007

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Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Death and/or ESRD defined as need for dialysis or plasma creatinine 500mmol/l [ Time Frame: May 2003 - Dec 2007 ]

Secondary Outcome Measures :
  1. Composite cardiovascular endpoints (acute myocardial infarction, revascularisation procedures, heart failure or unstable angina or arrhythmia requiring hospital admissions, lower extremity amputation) [ Time Frame: May 2003 - Dec 2007 ]
  2. Number of hospital admissions, total number of days of hospital stay and attendance at the Accident and Emergency Department [ Time Frame: May 2003 - Dec 2007 ]

Eligibility Criteria

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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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
  2. 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:

  1. patients with malignancy or other life-threatening diseases
  2. ultrasonographic evidence of obstructive uropathy which is amenable to surgical intervention
  3. non-diabetes related renal disease such as glomerulonephritis proven on renal biopsy reversible kidney disease, to be ruled out by ultrasonographic examination
  4. patients with clinically unstable psychiatric illnesses
  5. Patients who have 2 consecutive values of plasma creatinine concentration which differ by more than 20% within 3 months prior to recruitment.
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00309127


Locations
China
The Chinese University of Hong Kong
Hong Kong, China
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Juliana CN Chan, MB ChB, MD Department of Medicine and Therapeutics, The Chinese University of Hong Kong, The Prince of Wales Hospital, Shatin
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Juliana Chan, Chair Professor of Medicine and Therapeutics, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT00309127     History of Changes
Other Study ID Numbers: CRE-2004.226-T
HCPF No. 121012
First Posted: March 31, 2006    Key Record Dates
Last Update Posted: August 24, 2015
Last Verified: August 2015

Keywords provided by Juliana Chan, Chinese University of Hong Kong:
Type 2 Diabetes Mellitus
DM Nephropathy
Structured care

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Kidney Diseases
Kidney Failure, Chronic
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency