Aims/hypothesis

We conducted the largest and longest clinical trial comparing a whole-food, plant-based intervention with standard medical care (SMC) in individuals with type 2 diabetes.

Methods

We randomised (parallel-arm; computerised 1:1 randomisation ratio) 169 adults aged 18–75 years with type 2 diabetes in the Marshall Islands to an intensive whole-food, plant-based intervention with moderate exercise (PB+Ex) or SMC for 24 weeks. The PB+Ex intervention included 12 weeks of meals, exercise sessions and group classes. Primary outcomes were glycaemic control (HbA_1c, glucose, insulin and HOMA-IR) and glucose-lowering medication use. Secondary outcomes included lipids, blood pressure, heart rate and C-reactive protein. Only lab analysts were blinded.

Results

Compared with SMC (n=90 randomised; n=70 analysed), the PB+Ex (n=79 randomised; n=66 analysed) intervention decreased HbA_1c by an additional 14 mmol/mol (1.3%) at week 12 (−22 vs −7 mmol/mol [−2.0% vs −0.7%]; p<0.0001) and 8 mmol/mol (0.7%) at week 24 (−16 vs −8 mmol/mol [−1.4% vs −0.7%]; p=0.01). Concomitantly, 63% of medicated PB+Ex participants reduced their glucose-lowering medications (vs 24%; p=0.006), and 23% of PB+Ex participants with a baseline HbA_1c <75 mmol/mol (<9%) achieved remission. Additionally, the PB+Ex intervention reduced weight (−2.7 kg; p<0.0001), C-reactive protein (−11 nmol/l; p=0.005) and cardiovascular medication use compared with SMC. At intermediate timepoints, it improved glucose, insulin, HOMA-IR, cholesterol, triglycerides and heart rate, but not at week 24.

Conclusions/interpretation

A whole-food, plant-based lifestyle intervention was more effective for improving glycaemic control than SMC. It also reduced the need for diabetes and cardiovascular medications and induced diabetes remission in some participants. Therefore, it is an effective, evidence-based lifestyle option for individuals with type 2 diabetes.

Trial registration

ClinicalTrials.gov NCT03862963

Funding

This research was funded by the Department of the Army (W81XWH-05-1-0547). CJH received support through a National Institutes of Health Predoctoral T32 Obesity Fellowship (T32 HL105349).

Graphical Abstract

中文翻译：

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全食物、植物性强化生活方式干预可改善 2 型糖尿病患者的血糖控制并减少药物：一项随机对照试验

 目标/假设

我们进行了规模最大、持续时间最长的临床试验，比较了 2 型糖尿病患者的全食物、植物性干预与标准医疗保健 （SMC）。

 方法

我们将马绍尔群岛的 169 名年龄在 18-75 岁之间的 2 型糖尿病成人患者随机分配（平行组;计算机化 1：1 随机化比例）接受强化全食物、植物性干预，联合适度运动 （PB+Ex） 或 SMC，为期 24 周。PB+Ex 干预包括 12 周的膳食、锻炼课程和小组课程。主要结局是血糖控制 （HbA_1c、葡萄糖、胰岛素和 HOMA-IR） 和降糖药物的使用。次要结局包括血脂、血压、心率和 C 反应蛋白。只有实验室分析人员被设盲。

 结果

与 SMC 相比 （n=90 随机;分析了 n=70）、PB+Ex （n=79 随机;n=66 分析）干预在第 12 周时将 HbA_1c 额外降低了 14 mmol/mol （1.3%） （-22 vs -7 mmol/mol [-2.0% vs -0.7%];p<0.0001）和第 24 周时 8 mmol/mol （0.7%） （-16 vs -8 mmol/mol [-1.4% vs -0.7%];p=0.01）。同时，63% 的含药 PB+Ex 参与者减少了他们的降糖药物（对 24%;p=0.006），基线 HbA_1c <75 mmol/mol （<9%） 的 PB+Ex 参与者中有 23% 达到缓解。此外，PB+Ex 干预减轻了体重 （-2.7 kg;p<0.0001）、C 反应蛋白 （-11 nmol/l;p=0.005）和心血管药物使用与 SMC 相比。在中间时间点，它改善了葡萄糖、胰岛素、HOMA-IR、胆固醇、甘油三酯和心率，但在第 24 周没有改善。

结论/解释

全食物、植物性生活方式干预比 SMC 更有效地改善血糖控制。它还减少了对糖尿病和心血管药物的需求，并诱导了一些参与者的糖尿病缓解。因此，对于 2 型糖尿病患者来说，这是一种有效的、循证的生活方式选择。

 试用注册

ClinicalTrials.gov NCT03862963

 资金

这项研究由陆军部 （W81XWH-05-1-0547） 资助。CJH 通过美国国立卫生研究院博士前 T32 肥胖奖学金 （T32 HL105349） 获得支持。

 图形摘要