Aims/hypothesis

The aim of this study was to evaluate the impact on metabolic control of periodic use of a 5-day fasting-mimicking diet (FMD) programme as an adjunct to usual care in people with type 2 diabetes under regular primary care surveillance.

Methods

In this randomised, controlled, assessor-blinded trial, people with type 2 diabetes using metformin as the only glucose-lowering drug and/or diet for glycaemic control were randomised to receive 5-day cycles of an FMD monthly as an adjunct to regular care by their general practitioner or to receive regular care only. The primary outcomes were changes in glucose-lowering medication (as reflected by the medication effect score) and HbA_1c levels after 12 months. Moreover, changes in use of glucose-lowering medication and/or HbA_1c levels in individual participants were combined to yield a clinically relevant outcome measure (‘glycaemic management’), which was categorised as improved, stable or deteriorated after 1 year of follow-up. Several secondary outcome measures were also examined, including changes in body weight.

Results

One hundred individuals with type 2 diabetes, age 18–75 years, BMI ≥27 kg/m², were randomised to the FMD group (n=51) or the control group (n=49). Eight FMD participants and ten control participants were lost to follow-up. Intention-to-treat analyses, using linear mixed models, revealed adjusted estimated treatment effects for the medication effect score (−0.3; 95% CI −0.4, −0.2; p<0.001), HbA_1c (−3.2 mmol/mol; 95% CI −6.2, −0.2 and −0.3%; 95% CI −0.6, −0.0; p=0.04) and body weight (−3.6 kg; 95% CI −5.2, −2.1; p<0.001) at 12 months. Glycaemic management improved in 53% of participants using FMD vs 8% of control participants, remained stable in 23% vs 33%, and deteriorated in 23% vs 59% (p<0.001).

Conclusions/interpretation

Integration of a monthly FMD programme in regular primary care for people with type 2 diabetes who use metformin as the only glucose-lowering drug and/or diet for glycaemic control reduces the need for glucose-lowering medication, improves HbA_1c despite the reduction in medication use, and appears to be safe in routine clinical practice.

Trial registration

ClinicalTrials.gov NCT03811587

Funding

The project was co-funded by Health~Holland, Top Sector Life Sciences & Health, the Dutch Diabetes Foundation and L-Nutra.

Graphical Abstract

中文翻译：

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将模拟禁食饮食计划纳入 2 型糖尿病初级保健可减少药物需求并改善血糖控制：一项为期 12 个月的随机对照试验

目标/假设

本研究的目的是评估定期使用 5 天模拟禁食饮食 (FMD) 计划作为常规护理的辅助手段对接受定期初级保健监测的 2 型糖尿病患者的代谢控制的影响。

方法

在这项随机、对照、评估者盲法试验中，使用二甲双胍作为唯一降糖药物和/或饮食来控制血糖的 2 型糖尿病患者被随机分配，每月接受为期 5 天的 FMD 周期，作为常规护理的辅助手段由全科医生治疗或仅接受常规护理。主要结局是12 个月后降糖药物的变化（如药物效果评分所反映）和 HbA _1c水平。此外，将个体参与者降糖药物使用和/或 HbA _1c水平的变化结合起来，得出临床相关的结果测量（“血糖管理”），在一年的随访后将其分类为改善、稳定或恶化。向上。还检查了一些次要结果指标，包括体重变化。

结果

100 名 2 型糖尿病患者，年龄 18-75 岁，BMI ≥27 kg/m ²，被随机分为 FMD 组 ( n = 51) 或对照组 ( n = 49)。八名 FMD 参与者和十名对照参与者失访。使用线性混合模型的意向治疗分析揭示了药物效果评分的调整后估计治疗效果（-0.3；95% CI -0.4，-0.2；p <0.001）、HbA _1c（-3.2 mmol/mol；95 12 个月时的% CI -6.2，-0.2 和 -0.3%；95% CI -0.6，-0.0；p = 0.04）和体重（-3.6 kg；95% CI -5.2，-2.1；p <0.001）。使用 FMD 的参与者中有 53% 的血糖管理得到改善，而对照组参与者中这一比例为 8%；保持稳定的比例为 23% 相对于 33%；血糖管理恶化的比例为 23% 与 59%（p <0.001）。

结论/解释

对于使用二甲双胍作为唯一降糖药物和/或控制血糖的饮食的 2 型糖尿病患者，将每月 FMD 计划纳入常规初级保健中，可减少对降糖药物的需求，并在药物减少的情况下改善 HbA _1c使用，并且在常规临床实践中似乎是安全的。

试用注册

ClinicalTrials.gov NCT03811587

资金

该项目由 Health~Holland、Top Sector Life Sciences & Health、荷兰糖尿病基金会和 L-Nutra 共同资助。

图形概要