Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000112662
Ethics application status
Approved
Date submitted
4/08/2005
Date registered
9/08/2005
Date last updated
21/11/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Delay Future End Stage Nephropathy due to Diabetes
Scientific title
A randomised controlled trial to determine whether a community based model of blood pressure lowering, in Maori and Pacific patients with type 2 diabetes and early diabetic nephropathy, will delay the progression of renal dysfunction.
Universal Trial Number (UTN)
Trial acronym
DEFEND
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic Nephropathy 200 0
Condition category
Condition code
Metabolic and Endocrine 222 222 0 0
Diabetes
Renal and Urogenital 223 223 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The community based model of blood pressure lowering being tested will see trained healthcare assistants visiting patients in the intervention arm on a monthly basis to measure blood pressure, check compliance with medication and under supervision increase anti hypertensive therapy using an intensification protocol.
Intervention code [1] 112 0
Treatment: Other
Comparator / control treatment
Participants enrolled for 1 year. Standard patients will receive usual specialist (3 monthly visits) and primary health care.
Control group
Active

Outcomes
Primary outcome [1] 271 0
Change in Blood Pressure between groups.
Timepoint [1] 271 0
Blood pressure will be measured at baseline and at 1 year
Secondary outcome [1] 596 0
Myocardial infarction
Timepoint [1] 596 0
1 year
Secondary outcome [2] 597 0
Cerebral vascular accident
Timepoint [2] 597 0
The presence or absence of CVA will be established at baseline. At one year participants will be assessed for new CVAs
Secondary outcome [3] 598 0
New onset of ischaemic heart disease
Timepoint [3] 598 0
The presence or absence of IHD will be established at baseline. At one year participants will be assessed for new IHD
Secondary outcome [4] 599 0
New onset of symptoms of peripheral vascular disease
Timepoint [4] 599 0
The presence or absence of PVD will be established at baseline. At one year participants will be assessed for new PVD
Secondary outcome [5] 600 0
Amputation
Timepoint [5] 600 0
1 year
Secondary outcome [6] 601 0
Vascular procedure
Timepoint [6] 601 0
The presence or absence of vascular procedures will be established at baseline. At one year participants will be assessed for new vascular procedures
Secondary outcome [7] 602 0
Requirement for dialysis
Timepoint [7] 602 0
Participants will not be eligible for randomisation if they require dialysis. This will only be assessed at one year
Secondary outcome [8] 603 0
Hospitalisation
Timepoint [8] 603 0
1 year
Secondary outcome [9] 604 0
Echocardiography changes (LV mass, diastolic dysfunction).
Timepoint [9] 604 0
Echo will be carried out at baseline and one year.
Secondary outcome [10] 605 0
24 hour Blood pressure.
Timepoint [10] 605 0
24 hour BP will be carried out at baseline and one year

Eligibility
Key inclusion criteria
Maori and Pacific Islands patients with type 2 diabetes, with diabetic nephropathy (elevated 24 hour urine albumin of > 500mg /24hr and clinically defined using standard clinical symptoms/signs and exclusion of significant other causes for renal impairment) and impaired renal function (serum creatinine 0.10 to 0.3mmol/l) will be included in the study.
Minimum age
30 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation via secure web site
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer program was used to generate the random sequences. Blocking was used with variable block sizes.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
65
Accrual to date
Final
Recruitment outside Australia
Country [1] 133 0
New Zealand
State/province [1] 133 0

Funding & Sponsors
Funding source category [1] 280 0
Government body
Name [1] 280 0
Auckland District Health Board
Country [1] 280 0
New Zealand
Funding source category [2] 281 0
Commercial sector/Industry
Name [2] 281 0
Eli Lilly
Country [2] 281 0
New Zealand
Primary sponsor type
Individual
Name
John Collins
Address
Dept of Renal Medicine, 12th floor Auckland Hospital Support Building, Park Rd, Grafton, Auckland, 1023
Country
New Zealand
Secondary sponsor category [1] 215 0
Individual
Name [1] 215 0
Geoff Braatvedt
Address [1] 215 0
Dept of Medicine, Univeristy of Auckland, 12th floor Auckland Hospital Support Building, Park Rd, Grafton, Auckland, 1023
Country [1] 215 0
New Zealand
Secondary sponsor category [2] 216 0
Individual
Name [2] 216 0
Warwick Bagg
Address [2] 216 0
Dept of Medicine, Univeristy of Auckland, 12th floor Auckland Hospital Support Building, Park Rd, Grafton, Auckland, 1023
Country [2] 216 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1134 0
Central Auckland
Ethics committee address [1] 1134 0
Ethics committee country [1] 1134 0
New Zealand
Date submitted for ethics approval [1] 1134 0
Approval date [1] 1134 0
Ethics approval number [1] 1134 0
Ethics committee name [2] 1135 0
West Auckland and North shore
Ethics committee address [2] 1135 0
Ethics committee country [2] 1135 0
New Zealand
Date submitted for ethics approval [2] 1135 0
Approval date [2] 1135 0
Ethics approval number [2] 1135 0

Summary
Brief summary
This study will examine the effects of tight blood pressure control in Maori and Pacific patients with type 2 diabetes complicated by diabetic renal disease. It is already a well known that keeping blood pressure below 130/80 will delay the progression of renal disease caused by diabetes. However many patients do not achieve this level of blood pressure control. 65 people who meet the inclusion criteria will be allocated to either conventional treatment (general practitioner and specialist clinics) or community care (general practitioner, specialist clinics and a community health care worker). The community health care worker will be of the same ethnicity as the patient and will visit the person at home or their place of employment on a monthly basis. At these visits blood pressure will be measured and under the supervision of research doctor blood pressure medication will be adjusted if need be. This trial will involve 65 patients in the Central Auckland and West Auckland areas.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36213 0
Address 36213 0
Country 36213 0
Phone 36213 0
Fax 36213 0
Email 36213 0
Contact person for public queries
Name 9301 0
Warwick Bagg
Address 9301 0
Department of Medicine University of Auckland , 12th floor, Auckland Hospital Support Building
Country 9301 0
New Zealand
Phone 9301 0
+64 9 3737599 ext 89794
Fax 9301 0
Email 9301 0
[email protected]
Contact person for scientific queries
Name 229 0
Warwick Bagg
Address 229 0
Department of Medicine University of Auckland , 12th floor, Auckland Hospital Support Building
Country 229 0
New Zealand
Phone 229 0
+64 9 3737599 (Ext. 89794)
Fax 229 0
Email 229 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.