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

This study has been completed.
Sponsor:
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00309127
First received: March 30, 2006
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

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 Intervention
Type 2 Diabetes Mellitus
DM Nephropathy
Behavioral: Multidisciplinary team care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • Death and/or ESRD defined as need for dialysis or plasma creatinine 500mol/l

Secondary Outcome Measures:
  • Composite cardiovascular endpoints (acute myocardial infarction, revascularisation procedures, heart failure or unstable angina or arrhythmia requiring hospital admissions, lower extremity amputation)
  • Number of hospital admissions, total number of days of hospital stay and attendance at the Accident and Emergency Department

Estimated Enrollment: 240
Study Start Date: May 2004
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.

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
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 mol/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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Chinese University of Hong Kong

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00309127     History of Changes
Other Study ID Numbers: CRE-2004.226-T, HCPF No. 121012
Study First Received: March 30, 2006
Last Updated: March 30, 2006
Health Authority: Hong Kong: Department of Health

Keywords provided by 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

ClinicalTrials.gov processed this record on July 20, 2014