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Effects of lifestyle modification and active risk factor intervention on myocardial and vascular structure and reactivity in diabetes mellitus

The effect of exercise training and dietary intervention in apparently healthy subjects with type II diabetes mellitus in preventing cardiovascular disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12607000060448
Acronym
LIFESTYLE
Enrollment
240
Registered
2007-01-18
Start date
2003-01-12
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

Patients with type 2 diabetes are at risk of developing cardiovascular disease. Lifestyle changes and an exercise program may reduce damage to the structure and function of blood vessels and improve heart function. In this trial, subjects with type 2 diabetes will be randomly assigned to one of two groups – “Usual care” (ie standard treatment of diabetes according to guidelines) or “Active intervention” (additional measures such as frequent follow-up, additional dietary advice and an exercise program, in addition to usual care). The efficacy of these interventions on cardiovascular structure and function, exercise capacity, attainment of target biochemistry and outcome will be assessed after 1 month, 1 year and 3 years

Interventions

Intervention/s: The intervention group will undergo a 3-year program targeting lifestyle factors important in the development of cardiovascular complications of diabetes, and comprising 3 components; 1) Exercise training (both aerobic and strength training) will start with 1 month of twice-weekly supervised training, in combination with a home training program. After the supervised period, the program will be adjusted and patients will continue with this at home. Ongoing telephone contact will b

Intervention/s: The intervention group will undergo a 3-year program targeting lifestyle factors important in the development of cardiovascular complications of diabetes, and comprising 3 components; 1) Exercise training (both aerobic and strength training) will start with 1 month of twice-weekly supervised training, in combination with a home training program. After the supervised period, the program will be adjusted and patients will continue with this at home. Ongoing telephone contact will be maintained and the program altered according to progress. 2) Dietary advice will start with weekly dietician visits for 3 months. These will include weighing, 6 minute walk, review of dietary intake and education. Ongoing dietary advice will continue by provision of telephone contact and “refresher” courses every 6 months. 3) Ongoing personalized support and counselling by the study nurse, to ensure attendance for testing and optimize compliance with guideline-based medical therapy by the patient’s general practitioner, including aggressive management of insulin resistance and glucose levels.

Sponsors

Professor T Marwick
Lead SponsorIndividual

Study design

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

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Adults with type 2 diabetes including patients attending the Princess Alexandra Hospital Diabetes Clinic and patients recruited from the local community via advertisements.

Exclusion criteria

Unable/unwilling to comply with frequent follow-up, currently enrolled in another investigational study, life expectancy is severely limited due to pre-existing malignancy or other disease (<6 months), pregnancy.

Outcome results

None listed

Source: ANZCTR · Data processed: Apr 3, 2026