A whole-food, plant-based intensive lifestyle intervention improves glycaemic control and reduces medications in individuals with type 2 diabetes: a randomised controlled trial

IF 8.4 1区医学 Q1 ENDOCRINOLOGY & METABOLISM Diabetologia Pub Date : 2024-09-21 DOI:10.1007/s00125-024-06272-8

Cody J. Hanick, Courtney M. Peterson, Brenda C. Davis, Joan Sabaté, John H. Kelly

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Abstract

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

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全食物、以植物为基础的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用药：随机对照试验

我们对马绍尔群岛 169 名 18-75 岁的 2 型糖尿病患者进行了为期 24 周的随机分组（平行臂；计算机化 1:1 随机分配比例），将他们分配到强化全食物、植物性干预和适度运动（PB+Ex）或标准医疗护理（SMC）中。PB+Ex 干预包括 12 周的膳食、运动课程和小组课程。主要结果是血糖控制（HbA1c、葡萄糖、胰岛素和 HOMA-IR）和降糖药物的使用。次要结果包括血脂、血压、心率和 C 反应蛋白。结果与 SMC（随机人数=90；分析人数=70）相比，PB+Ex（随机人数=79；分析人数=66）干预在第 12 周将 HbA1c 再降低 14 mmol/mol（1.3%），第 24 周时降低 8 mmol/mol (0.7%) (-16 vs -8 mmol/mol [-1.4% vs -0.7%]; p=0.01)。同时，63% 的 PB+Ex 参与者减少了降糖药物的服用（vs 24%；p=0.006），基线 HbA1c 为 75 mmol/mol (<9%) 的 PB+Ex 参与者中有 23% 实现了病情缓解。此外，与 SMC 相比，PB+Ex 干预措施降低了体重（-2.7 千克；p<0.0001）、C 反应蛋白（-11 毫摩尔/升；p=0.005）和心血管药物使用量。在中间时间点，它改善了血糖、胰岛素、HOMA-IR、胆固醇、甘油三酯和心率，但在第 24 周时没有改善。结论/解释与 SMC 相比，全食物、以植物为基础的生活方式干预对改善血糖控制更有效。它还减少了对糖尿病和心血管药物的需求，并使一些参与者的糖尿病得到缓解。因此，对于 2 型糖尿病患者来说，这是一种有效的、以证据为基础的生活方式选择。试验注册ClinicalTrials.gov NCT03862963资助本研究由陆军部（W81XWH-05-1-0547）资助。CJH获得了美国国立卫生研究院T32肥胖症博士前期奖学金（T32 HL105349）的资助。

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来源期刊

Diabetologia 医学-内分泌学与代谢

CiteScore

18.10

自引率

2.40%

发文量

193

审稿时长

1 months

期刊介绍： Diabetologia, the authoritative journal dedicated to diabetes research, holds high visibility through society membership, libraries, and social media. As the official journal of the European Association for the Study of Diabetes, it is ranked in the top quartile of the 2019 JCR Impact Factors in the Endocrinology & Metabolism category. The journal boasts dedicated and expert editorial teams committed to supporting authors throughout the peer review process.