4.5 Article

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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ELSEVIER SCI LTD
DOI: 10.1016/j.numecd.2007.07.006

关键词

Type 2 diabetes; Lifestyle intervention; Physical exercise; Fitness; Cardiovascular risk factors

资金

  1. LifeScan Italia
  2. Johnson Et Johnson Medical Spa
  3. Novo Nordisk Ltd
  4. Bristol Myers Squibb
  5. Technogym SPA
  6. Cosmed SrL

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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/m(2), 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. (C) 2007 Elsevier B.V. All rights reserved.

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