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Delay Future End Stage Nephropathy due to Diabetes

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.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12605000112662
Acronym
DEFEND
Enrollment
65
Registered
2005-08-09
Start date
2004-11-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Sponsors

John Collins
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
30 Years to 75 Years
Healthy volunteers
No

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.

Exclusion criteria

No exclusion criteria

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026