Department of Medicine, University of Otago,Wellington, New Zealand.
Diabetologia. 2012 Apr;55(4):905-14. doi: 10.1007/s00125-012-2461-0.
AIMS/HYPOTHESIS: To compare the effectiveness of low-fat high-protein and low-fat high-carbohydrate dietary advice on weight loss, using group-based interventions, among overweight people with type 2 diabetes. Study design Multicentre parallel (1:1) design, blinded randomised controlled trial.
Individuals with type 2 diabetes aged 30–75 years and a BMI >27 kg/m2 were randomised, by an independent statistician using sequentially numbered sealed envelopes, to be prescribed either a low-fat high-protein (30% of energy as protein, 40% as carbohydrate, 30% as fat) or a low-fat high carbohydrate(15% of energy as protein, 55%as carbohydrate,30% as fat) diet. Participants attended 18 group sessions over 12 months. Primary outcomes were change in weight and waist circumference assessed at baseline, 6 and 12 months.Secondary outcomes were body fatness, glycaemic control,lipid profile, blood pressure and renal function. A further assessment was undertaken 12 months after the intervention.Research assessors remained blinded to group allocation throughout. Intention-to-treat analysis was performed.
A total of 419 participants were enrolled (mean±SDage 58±9.5 years,BMI 36.6±6.5 kg/m2 and HbA1c 8.1±1.2%(65 mmol/mol)). The study was completed by 70%(294/419).No differences between groups were found in change in weight or waist circumference during the intervention phase or the 12-month follow-up. Both groups had lost weight (2–3 kg, p<0.001) and reduced their waist circumference (2–3 cm, p<0.001) by 12 months and largely maintained this weight loss for the following 12 months. By 6 months, the difference in self-reported dietary protein between groups was small (1.1%total energy; p<0.001). No significant differences between groups were found in secondary outcomes: body fatness, HbA1c, lipids, blood pressure and renal function.There were no important adverse effects.
CONCLUSIONS/INTERPRETATION: In a 'real-world' setting, prescription of an energy-reduced low-fat diet, with either increased protein or carbohydrate, results in similar modest losses in weight and waist circumference over 2 years
目的/假设：比较基于小组干预的低脂高蛋白和低脂高碳水化合物饮食建议在超重 2 型糖尿病患者中减肥的效果。研究设计：多中心平行（1:1）设计，盲随机对照试验。
年龄 30-75 岁、BMI>27kg/m2 的 2 型糖尿病患者，由独立统计学家使用连续编号的密封信封随机分组，分别接受低脂高蛋白（能量的 30%来自蛋白质，40%来自碳水化合物，30%来自脂肪）或低脂高碳水化合物（能量的 15%来自蛋白质，55%来自碳水化合物，30%来自脂肪）饮食。参与者在 12 个月内参加 18 次小组会议。主要结局指标为基线、6 个月和 12 个月时体重和腰围的变化。次要结局指标为体脂率、血糖控制、血脂谱、血压和肾功能。干预后 12 个月进行进一步评估。研究评估人员在整个过程中保持对分组分配的盲态。意向治疗分析。
共纳入 419 名参与者（平均年龄 58±9.5 岁，BMI 36.6±6.5kg/m2，HbA1c 8.1±1.2%（65mmol/mol））。419 名参与者中有 70%（294 名）完成了研究。干预阶段和 12 个月随访期间，两组体重或腰围变化无差异。两组体重均减轻（2-3kg，p<0.001），腰围减少（2-3cm，p<0.001），12 个月后基本维持体重减轻。6 个月时，两组报告的膳食蛋白质差异较小（总能量的 1.1%；p<0.001）。两组在次要结局方面无显著差异：体脂率、HbA1c、血脂、血压和肾功能。无重要不良事件发生。
结论/解释：在“真实世界”环境中，给予能量减少的低脂饮食，增加蛋白质或碳水化合物，在 2 年内体重和腰围的适度减轻效果相似。
