Effects of exercise training alone vs a combined exercise and nutritional lifestyle intervention on glucose homeostasis in prediabetic individuals: a randomised controlled trial.
Effects of exercise training alone vs a combined exercise and nutritional lifestyle intervention on glucose homeostasis in prediabetic individuals: a randomised controlled trial.
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DOI：
10.1007/s00125-016-4051-z
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发表时间：
2016-10
期刊：
影响因子：
8.2
通讯作者：
Kraus WE
中科院分区：
文献类型：
--
作者：
Slentz CA;Bateman LA;Willis LH;Granville EO;Piner LW;Samsa GP;Setji TL;Muehlbauer MJ;Huffman KM;Bales CW;Kraus WE
尽管糖尿病预防计划（DPP）将生活方式改变（饮食、运动和减肥）确立为糖尿病预防治疗的“金标准”，但运动单独对DPP饮食和运动联合作用的总体效用的相对贡献尚不清楚;此外，预防糖尿病进展的最佳运动强度仍存在很大争议。为了确定临床疗效，我们进行了一项研究（2009年至2013年），以确定：在DPP的前6个月后建模的6个月计划对葡萄糖稳态指标的影响有多大程度上是由运动单独引起的;中等强度或剧烈强度的运动是否更好地改善葡萄糖稳态;以及运动量在多大程度上有助于改善葡萄糖控制。主要终点是空腹血糖的改善，OGTT后血糖AUC反应的改善是主要的次要终点。该试验是一项平行临床试验。在杜克大学研究了来自达勒姆地区的45-75岁空腹血糖升高（5.28-6.94 mmol/l）但无心血管疾病、不受控制的高血压或糖尿病的不吸烟者（n=195）。他们被随机分为四个6个月的干预措施之一：（1）低量（42 kJ/kg体重−1周−1 [KKW]）/中等强度：相当于消耗42 KKW（例如，每周步行约16公里[8.6英里]），中等强度（50%峰值V ~ O2储备）运动;（2）高量（67 KKW）/中等强度：相当于消耗67 KKW（每周约22.3公里[13.8英里]），中等强度运动;（3）高量（67 KKW）/剧烈强度：相当于第2组，但进行剧烈强度运动（75%峰值V ~ 2 O ~ 2储备）;和（4）饮食+ 42 KKW中等强度：与第1组相同，但饮食和体重减轻（7%）以模拟DPP的前6个月。由我们的统计师（GPS）提供计算机生成的随机化列表。随机化列表由LHW和CAS维护，不了解时间安排或对其进行输入，而所有时间安排均由LAB完成，不了解随机化列表。受试者在OGTT当天由LHW自动分配至随机化表上列出的下一组（无法操纵列表顺序）。所有血浆分析均由进行测量（即脂质、葡萄糖、胰岛素）的个体设盲进行。受试者和研究人员（分析血液的个人除外）对分组不设盲。每组的随机化人数、完成者人数和使用完整OGTT数据分析的人数分别为：低剂量/中等强度（61，43，35）;高剂量/中等强度（61，44，40）;高剂量/高强度（61，43，38）;饮食/运动（54，45，37）。只有饮食和运动组的空腹血糖下降（p<0.001）。各组空腹血糖（mmol/l）变化的平均值和95% CI为：高量/中等强度-0.07（-0.20，0.06）;高量/剧烈0.06（-0.07，0.19）;低量/中等0.05（-0.05，0.15）;饮食/运动-0.32（-0.46，-0.18）。各组的效应量（同序）分别为：0.17、0.15、0.18和0.71。对于葡萄糖耐量（OGTT的葡萄糖AUC），观察到饮食和运动组（改善8.2%，效应量0.73）和67 KKW中等强度运动组（改善6.4%，效应量0.60）的改善相似;中等强度运动比同等强度运动更有效（p<0.0207）。单独进行等量的高强度运动并没有显著改善葡萄糖耐量（改善1.2%，效应量0.21）。胰岛素AUC、空腹血糖和胰岛素的变化在运动组之间没有差异，并且在数值上劣于饮食和运动组。在目前的临床疗效试验中，我们发现单独进行大量中等强度的运动对改善口服葡萄糖耐量非常有效，尽管体脂量变化相对较小，仅为2 kg。这些数据，结合大量已发表的关于餐后血糖浓度与未来糖尿病预测之间强独立关系的观察结果，表明步行~18.2 km（67 KKW中等强度组中规定22.3 km，依从率为81.6%）每周可能几乎与涉及饮食的更密集的多组分方法一样有效，运动和体重减轻以预防前驱糖尿病个体发展为糖尿病。这些发现对临床干预的选择具有重要意义，以防止高危人群进展为2型糖尿病。ClinicalTrials.gov NCT00962962
Although the Diabetes Prevention Program (DPP) established lifestyle changes (diet, exercise and weight loss) as the ‘gold standard’ preventive therapy for diabetes, the relative contribution of exercise alone to the overall utility of the combined diet and exercise effect of DPP is unknown; furthermore, the optimal intensity of exercise for preventing progression to diabetes remains very controversial. To establish clinical efficacy, we undertook a study (2009 to 2013) to determine: how much of the effect on measures of glucose homeostasis of a 6 month programme modelled after the first 6 months of the DPP is due to exercise alone; whether moderate- or vigorous-intensity exercise is better for improving glucose homeostasis; and to what extent amount of exercise is a contributor to improving glucose control. The primary outcome was improvement in fasting plasma glucose, with improvement in plasma glucose AUC response to an OGTT as the major secondary outcome. The trial was a parallel clinical trial. Sedentary, non smokers who were 45–75 year old adults (n=195) with elevated fasting glucose (5.28–6.94 mmol/l) but without cardiovascular disease, uncontrolled hypertension, or diabetes, from the Durham area, were studied at Duke University. They were randomised into one of four 6 month interventions: (1) low amount (42 kJ kg body weight−1 week−1 [KKW])/moderate intensity: equivalent of expending 42 KKW (e.g. walking ~16 km [8.6 miles] per week) with moderate-intensity (50% peak V̇O2reserve) exercise; (2) high amount (67 KKW)/moderate intensity: equivalent of expending 67 KKW (~22.3 km [13.8 miles] per week) with moderate-intensity exercise; (3) high amount (67 KKW)/vigorous intensity: equivalent to group 2, but with vigorous-intensity exercise (75% peak V̇O2reserve); and (4) diet + 42 KKW moderate intensity: same as group 1 but with diet and weight loss (7%) to mimic the first 6 months of the DPP. Computer-generated randomisation lists were provided by our statistician (GPS). The randomisation list was maintained by LHW and CAS with no knowledge of or input into the scheduling, whereas all scheduling was done by LAB, with no knowledge of the randomisation list. Subjects were automatically assigned to the next group listed on the randomisation sheet (with no ability to manipulate the list order) on the day that they came in for the OGTT, by LHW. All plasma analysis was done blinded by the individuals doing the measurements (i.e. lipids, glucose, insulin). Subjects and research staff (other than individuals analysing the blood) were not blinded to the group assignments. Number randomised, completers and number analysed with complete OGTT data for each group were: low-amount/moderate-intensity (61, 43, 35); high-amount/moderate-intensity (61, 44, 40); high-amount/vigorous-intensity (61, 43, 38); diet/exercise (54, 45, 37), respectively. Only the diet and exercise group experienced a decrease in fasting glucose ( p<0.001). The means and 95% CIs for changes in fasting glucose (mmol/l) for each group were: high-amount/moderate-intensity −0.07 (−0.20, 0.06); high-amount/vigorous 0.06 (−0.07, 0.19); low-amount/moderate 0.05 (−0.05, 0.15); and diet/exercise −0.32 (−0.46, −0.18). The effects sizes for each group (in the same order) were: 0.17, 0.15, 0.18 and 0.71, respecively. For glucose tolerance (glucose AUC of OGTT), similar improvements were observed for the diet and exercise (8.2% improvement, effect size 0.73) and the 67 KKW moderate-intensity exercise (6.4% improvement, effect size 0.60) groups; moderate-intensity exercise was significantly more effective than the same amount of vigorous-intensity exercise (p<0.0207). The equivalent amount of vigorous-intensity exercise alone did not significantly improve glucose tolerance (1.2% improvement, effect size 0.21). Changes in insulin AUC, fasting plasma glucose and insulin did not differ among the exercise groups and were numerically inferior to the diet and exercise group. In the present clinical efficacy trial we found that a high amount of moderate-intensity exercise alone was very effective at improving oral glucose tolerance despite a relatively modest 2 kg change in body fat mass. These data, combined with numerous published observations of the strong independent relation between postprandial glucose concentrations and prediction of future diabetes, suggest that walking ~18.2 km (22.3 km prescribed with 81.6% adherence in the 67 KKW moderate-intensity group) per week may be nearly as effective as a more intensive multicomponent approach involving diet, exercise and weight loss for preventing the progression to diabetes in prediabetic individuals. These findings have important implications for the choice of clinical intervention to prevent progression to type 2 diabetes for those at high risk. ClinicalTrials.gov NCT00962962