The Italian Diabetes and Exercise Study (IDES): Design and methods for a prospective Italian multicentre trial of intensive lifestyle intervention in people with type 2 diabetes and the metabolic syndrome

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Abstract

Background and aims

The IDES is a prospective Italian multicentre randomized controlled trial to evaluate the efficacy of an intensive lifestyle intervention on modifiable cardiovascular disease (CVD) risk factors in a large cohort of people with type 2 diabetes and the metabolic syndrome.

Methods and results

We recruited 606 subjects with type 2 diabetes and waist circumference >94 cm (M) and >80 cm (F), plus >1 other metabolic syndrome trait (IDF criteria) for both sexes, aged 40–75 years, BMI 27–40 kg/m2, diabetes duration >1 year with a sedentary lifestyle of >6 months. Patients were randomized into two groups: a control group, receiving conventional care including exercise counselling and an intervention group, treated with a mixed (aerobic and resistance) exercise programme (150 min/week) prescribed and supervised for 12 months. Primary outcome is HbA1c reduction. Secondary outcomes include other traditional and non-traditional risk factors and their relationship to exercise volume/intensity and fitness; dosage of glucose, lipid and blood pressure-lowering drugs; global CVD 10-year risk; patient well-being; and costs.

Conclusion

This trial verifies whether a prescribed and supervised exercise programme, including both aerobic and resistance training, is more effective than conventional exercise counselling in reducing modifiable CVD risk factors in type 2 diabetic subjects with the metabolic syndrome.

Introduction

Prevalence of diabetes mellitus, particularly type 2, is rapidly increasing worldwide and, although the rise is more pronounced in developing countries, Europe and North America are not spared [1]. As a consequence, the burden of the disabling long-term complications of diabetes is expected to rise, with an inevitable increase in the social and economic costs associated with the disease.

People with diabetes are at higher risk for macro- and microvascular disease than the general population [2]. The increased morbidity and mortality for cardiovascular disease (CVD) has been attributed to chronic hyperglycaemia per se and co-morbid conditions occurring in diabetic patients more frequently than in non-diabetic subjects. These conditions include central obesity, dyslipidaemia and arterial hypertension, which have been shown to cluster and associate with insulin resistance and disturbances of glucose metabolism, thus suggesting the existence of a unique pathophysiological condition, called the metabolic syndrome [3].

Sedentary habits have been associated with an increased prevalence of diabetes and the metabolic syndrome. Moreover, a low cardiorespiratory fitness was shown to be a powerful and independent predictor of all-cause- and CVD-mortality in type 2 diabetic subjects [4], [5], [6], [7]. Conversely, lifestyle-modification programmes, including physical activity, were shown to prevent the development of type 2 diabetes in high risk subjects; this was associated with significant improvements in body weight, central adiposity, HbA1c and lipid levels, insulin sensitivity and prevalence of hypertension [8], [9], [10], [11], [12], [13]. Moreover, in type 2 diabetic patients, a moderate or high level of physical activity (occupational, commuting and leisure time) reduced total and CVD mortality by improving glycaemic control and other CVD risk factors [14], [15].

The Italian Diabetes and Exercise Study (IDES) was designed to evaluate the efficacy of an intensive mixed (aerobic and resistance) exercise training programme, prescribed and supervised, on modifiable CVD risk factors, as compared with standard care including exercise counselling in type 2 diabetic subjects with the metabolic syndrome. This paper describes the study design and methods.

Section snippets

Study design

The study complies with the Declaration of Helsinki. The research protocol was approved by the locally appointed ethics committees.

Primary outcome

The primary research goal was the evaluation of the efficacy of a mixed exercise training programme, prescribed and supervised, as compared with standard care, in terms of HbA1c reduction.

Secondary outcomes

Secondary research goals included an exploration of:

  • Percentage of patients in each group that after 12 months achieved one or more of the following targets: a >15% reduction of HbA1c levels; a >15% reduction of serum triglyceride levels; a >15% reduction of serum LDL-cholesterol levels; a >5% of serum

Discussion

Modifiable CVD risk factors represent the main endpoints of this study because it has been clearly demonstrated that physical exercise has a beneficial effect on CVD mortality and morbidity in type 2 diabetic patients by improving glycemic control as well as other CVD risk factors, including those clustering in the metabolic syndrome [23], [24], [25], [26], [27]. Recent evidence suggests that physical exercise also reduces inflammation, oxidative stress and endothelial dysfunction associated

Acknowledgement

This project, proposed by the Metabolic Fitness Organization of Italy, a non-profit foundation, has received the support of grants from LifeScan Italia, Johnson & Johnson Medical Spa, Novo Nordisk Ltd, Bristol Myers Squibb, Technogym SPA and Cosmed SrL. The IDES Study Group is registered as ISRCTN04252749.

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    This paper is dedicated to the memory of Umberto Di Mario (1948–2004). His warmth and intellectual curiosity were inspirational to all of us.

    1

    A complete list of the members of the IDES Research Group and their professional affiliations can be found in Appendix A.

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