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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

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....

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Published in:Nutrition, metabolism, and cardiovascular diseases metabolism, and cardiovascular diseases, 2008-11, Vol.18 (9), p.585-595
Main Authors: Balducci, Stefano, Zanuso, Silvano, Massarini, Massimo, Corigliano, Gerardo, Nicolucci, Antonio, Missori, Serena, Cavallo, Stefano, Cardelli, Patrizia, Alessi, Elena, Pugliese, Giuseppe, Fallucca, Francesco
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Language:English
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Summary: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.
ISSN:0939-4753
1590-3729
DOI:10.1016/j.numecd.2007.07.006