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Prevention of heart failure in type 2 diabetes by exercise intervention: protocol and design of the PROTECTION study


 
 
 Type of funding sources: Public grant(s) – National budget only. Main funding source(s): research Foundation - Flanders (FWO)
 
 
 
 Cardiac dysfunction is highly prevalent in patients with type 2 diabetes mellitus (T2DM), leading to increased risk of cardiac morbidity and premature death. Previous research underscored the high prevalence of a disturbed global longitudinal strain (GLS), a marker to predict this cardiac dysfunction, in both symptomatic and asymptomatic T2DM patients. Exercise-based therapy is recommended in the management of patients with type 2 diabetes. However, it remains unclear i) which type of exercise therapy to have the biggest effect on GLS and ii) which factors modify the effect of exercise therapy on GLS.
 
 
 
 The PROTECTION study will i) investigate the impact of exercise volume and intensity on GLS to optimize exercise prescription in T2DM and will ii) assess which patient-specific factors influence the change in GLS and physical fitness as a result of exercise intervention in T2DM.
 
 
 
 The PROTECTION study is composed of two work packages (WP). In WP 1, 100 T2DM adults (50% male, aged 30-75 years) will be randomized to a usual care group or one of the three supervised exercise intervention groups (see Table 1) for a duration of 26 weeks. Outcome measures will be performed at baseline, 13, 26 and 52 weeks of follow-up. The primary outcomes are GLS and cardiac dimensions. Secondary outcomes include health-related physical fitness, blood biomarkers and physical activity behavior. Data will be analyzed by two-way ANOVA repeated measures. A two-tailed P-value <0.05 will be considered statistically significant.
 Parallel with the randomized controlled trial, a longitudinal intervention study (WP2) involving 107 adults (50% male, aged 30-75 years) with T2DM will be conducted. All participants will engage in a supervised intervention for 26 weeks, including a high volume of moderate intense physical activity (see Table 1). The main objective of this work package is to define determinants of change in GLS during an exercise intervention. Moreover, the interaction between diet-exercise, habitual physical activity-exercise and phenotype-exercise on change in GLS will be studied in great detail. Patient-specific data will be analyzed by multivariate regression analysis. A two-tailed P-value <0.05 will be considered statistically significant.
 
 
 
 It is anticipated that the PROTECTION study will contribute to a better understanding on i) which exercise characteristics are preferred to maximally improve GLS in T2DM and on ii) the determinants of the responsiveness of GLS and physical fitness to exercise in T2DM.
