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
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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DOI：
10.1016/j.numecd.2007.07.006
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发表时间：
2008-11-01
影响因子：
3.9
通讯作者：
Fallucca, Francesco
中科院分区：
文献类型：
--
作者：
Balducci, Stefano;Zanuso, Silvano;Fallucca, Francesco
背景和目标：IDES是一项前瞻性的意大利多中心随机对照试验，旨在评估在2型糖尿病和代谢综合征患者的大型队列中，强化生活方式干预对可改变的心血管疾病（CVD）风险因素的疗效。方法和结果：我们招募了606名2型糖尿病患者，腰围>94 cm（男性）和>80 cm（女性），加上>1个其他代谢综合征特征（IDF标准）男女，年龄40-75岁，BMI 27-40 kg/m2，糖尿病病程>1年，久坐生活方式>6个月。患者被随机分为两组：对照组，接受常规护理，包括运动咨询和干预组，治疗与混合（有氧和阻力）运动计划（150分钟/周）规定和监督12个月。主要结局是HbA 1c降低。次要结果包括其他传统和非传统风险因素及其与运动量/强度和健身的关系;血糖、血脂和降压药物的剂量;全球CVD 10年风险;患者健康;和成本。这项试验验证了一个规定和监督的锻炼计划，包括有氧和阻力训练，在降低2型糖尿病代谢综合征受试者中可改变的CVD危险因素方面，比传统的运动咨询更有效。(C)2007 Elsevier B. V.保留所有权利。
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.