Key result
Supervised exercise-based lifestyle intervention fails to reduce diastolic dysfunction vs usual care in T2DM.
Why the study?
Diastolic dysfunction is associated with adverse cardiovascular outcomes, and the impact of exercise-based lifestyle intervention on its evolution in patients with type 2 diabetes mellitus was unclear.
RCT (n=223)
randomized
Does not support supervised exercise for diastolic dysfunction prevention in T2DM; hypothesis-generating and requires randomized confirmation.
BACKGROUND: Diastolic dysfunction (DD) is associated with adverse cardiovascular outcomes. We studied the impact of an exercise-based lifestyle intervention on the evolution of DD in patients with type 2 diabetes mellitus (T2DM) and prospectively investigated the clinical correlates of DD progression. METHODS AND RESULTS: A total of 223 outpatients with T2DM were randomized to supervised exercise-based lifestyle intervention (initial gym-based program and lifestyle and diet advice followed by telephone-guided supervision) or usual care. Patients underwent echocardiographic assessment of diastolic function and metabolic and clinical evaluation at baseline and 3 years. Changes in prevalence and evolution of DD were assessed and correlations sought with clinical and metabolic variables. DD was present in 50% of patients at baseline and 54% at 3 years, with no difference between the usual care and intervention groups (60% versus 48%, P=0.10). Abnormal DD at the final visit was independently associated with older age and a decrease in peak oxygen consumption over time (P<0.05). There was no impact on glycemic control or exercise capacity. In a subanalysis restricted to patients who finished the full 3-year follow-up, control subjects were independently associated with DD at 3 years (β=0.90; odds ratio, 2.46; P=0.034), with the only other independent correlate being older age (β=0.05; odds ratio, 1.06; P=0.019). CONCLUSIONS: Despite being efficacious in the subgroup who completed 3 years of exercise-based lifestyle intervention, randomization to this program was not effective in reducing progression of subclinical DD in patients with T2DM, which may reflect the recognized difficulty of adherence to prolonged exercise intervention. CLINICAL TRIAL REGISTRATION: URL: http://www.anzctr.org.au. Unique identifier: ACTRN12607000060448.
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Hare et al. (2011) conducted an RCT in type 2 diabetes mellitus (n=223). Supervised exercise-based lifestyle intervention vs. Usual care was evaluated on Prevalence of diastolic dysfunction at 3 years (p=0.10). A supervised exercise-based lifestyle intervention did not significantly reduce the prevalence of diastolic dysfunction at 3 years compared to usual care in patients with T2DM (48% vs 60%; P=0.10).
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