新诊断 2 型糖尿病患者的饮食或饮食加体力活动与常规护理的比较：早期 ACTID 随机对照试验。
Diet or diet plus physical activity versus usual care in patients with newly diagnosed type 2 diabetes: the Early ACTID randomised controlled trial.
机构信息
School of Clinical Sciences, University of Bristol, Bristol, UK.
出版信息
Lancet. 2011 Jul 9;378(9786):129-39. doi: 10.1016/S0140-6736(11)60442-X. Epub 2011 Jun 24.
BACKGROUND
Lifestyle changes soon after diagnosis might improve outcomes in patients with type 2 diabetes mellitus, but no large trials have compared interventions. We investigated the effects of diet and physical activity on blood pressure and glucose concentrations.
METHODS
We did a randomised, controlled trial in southwest England in adults aged 30-80 years in whom type 2 diabetes had been diagnosed 5-8 months previously. Participants were assigned usual care (initial dietary consultation and follow-up every 6 months; control group), an intensive diet intervention (dietary consultation every 3 months with monthly nurse support), or the latter plus a pedometer-based activity programme, in a 2:5:5 ratio. The primary endpoint was improvement in glycated haemoglobin A(1c)(HbA(1c)) concentration and blood pressure at 6 months. Analysis was done by intention to treat. This study is registered, number ISRCTN92162869.
FINDINGS
Of 593 eligible individuals, 99 were assigned usual care, 248 the diet regimen, and 246 diet plus activity. Outcome data were available for 587 (99%) and 579 (98%) participants at 6 and 12 months, respectively. At 6 months, glycaemic control had worsened in the control group (mean baseline HbA(1c) percentage 6·72, SD 1·02, and at 6 months 6·86, 1·02) but improved in the diet group (baseline-adjusted difference in percentage of HbA(1c) -0·28%, 95% CI -0·46 to -0·10; p=0·005) and diet plus activity group (-0·33%, -0·51 to -0·14; p<0·001). These differences persisted to 12 months, despite less use of diabetes drugs. Improvements were also seen in bodyweight and insulin resistance between the intervention and control groups. Blood pressure was similar in all groups.
INTERPRETATION
An intensive diet intervention soon after diagnosis can improve glycaemic control. The addition of an activity intervention conferred no additional benefit.
FUNDING
Diabetes UK and the UK Department of Health.
背景
在诊断后不久进行生活方式的改变可能会改善 2 型糖尿病患者的预后，但还没有大型试验比较过各种干预措施。我们旨在研究饮食和身体活动对血压和血糖浓度的影响。
方法
我们在英格兰西南部进行了一项随机对照试验，纳入了年龄在 30-80 岁之间、在过去 5-8 个月被诊断为 2 型糖尿病的成年人。参与者被随机分配到常规护理组（初始饮食咨询和每 6 个月一次的随访；对照组）、强化饮食干预组（每 3 个月进行一次饮食咨询，并每月接受护士支持）或后者加上基于计步器的活动方案组，比例为 2:5:5。主要终点是 6 个月时糖化血红蛋白 A1c（HbA1c）浓度和血压的改善。分析采用意向治疗。这项研究已注册，编号为 ISRCTN92162869。
结果
在 593 名符合条件的个体中，99 名被分配到常规护理组，248 名被分配到饮食组，246 名被分配到饮食加活动组。分别有 587（99%）和 579（98%）名参与者在 6 个月和 12 个月时获得了结局数据。在 6 个月时，对照组的血糖控制情况恶化（平均基线 HbA1c 百分比为 6.72，标准差为 1.02，而在 6 个月时为 6.86，1.02），但饮食组（HbA1c 百分比的基线调整差异为-0.28%，95%CI-0.46 至-0.10；p=0.005）和饮食加活动组（-0.33%，-0.51 至-0.14；p<0.001）的情况有所改善。尽管糖尿病药物的使用减少了，但这些差异在 12 个月时仍然存在。干预组和对照组之间的体重和胰岛素抵抗也有改善。所有组的血压相似。
解释
在诊断后不久进行强化饮食干预可以改善血糖控制。活动干预的加入没有带来额外的益处。
资金来源
英国糖尿病协会和英国卫生部。
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