睡前零食增加妊娠糖尿病患者血糖血脂水平

The effect of bedtime snacks on morning fasting blood glucose in gestational diabetes mellitus: A randomized controlled trial

睡前零食对妊娠期糖尿病患者空腹血糖的影响的一项随机对照试验

Authors: Tianli Zhu, Jingjing Liu, Tuyan Fan, Hui Gao, Shuangqin Yan, Xiaomin Jia, Fengyu Yang, Ziwei Ding, Le Wang, Lanfang Zhao, Peng Zhu, Fangbiao Tao, Beibei Zhu

Source: Acta Diabetologica

DOI: 10.1007/s00592-025-02445-y

Abstract

Background: While guidelines recommend bedtime snacks for women with gestational diabetes mellitus (GDM), there is insufficient evidence championed those recommendation.

Objective: To evaluate if bedtime snacking is effective in preventing high fasting blood glucose incidence among women with GDM.

Methods:An open-label, parallel-group, randomized controlled trial was conducted from December 2023 to July 2024 at Ma'anshan Maternal and Child Health Care Center, Anhui, China. They were randomly and equally allocated to groups of bedtime snacks (25g nuts, intervention group) and no bedtime snacks (control group). The intervention was lasted for 8 weeks, during which fasting blood glucose was measured 3 times per week, 1-hour postprandial glucose and 2-hour postprandial glucose 2 times per week with a home glucometer. In the late pregnancy (approximately at 34 weeks), the glycated haemoglobin, high-density lipoprotein, low-density lipoprotein, triglycerides, total cholesterol were measured in the laboratory and birth outcomes information (birth weight, gestational weeks at delivery, delivery mode) were collected. The primary outcomes were the level of fasting blood glucose and the hyper-fasting blood glucose incidence during 8-week duration. The secondary outcomes were the level of the glycated haemoglobin, high-density lipoprotein, low-density lipoprotein, triglycerides and total cholesterol in the late pregnancy. Generalized estimating equations and analysis of covariates were conducted for the analysis of the primary outcomes. The multivariate linear regression was conducted for the analysis of the secondary outcomes. Post-hoc analysis was also conducted for the indicators of 1-hour postprandial glucose, 2-hour postprandial glucose and perinatal outcomes applying generalized estimating equations, analysis of covariates, the multivariate linear regression and logistics regression.

Results: A total of 62 GDM cases at the nutrition clinics were enrolled and completed the follow-up, with 31 in the intervention group and 31 in the control group. After adjusting for maternal age, pre-pregnancy body mass index, mid-pregnancy glucose, mid-pregnancy blood lipids and diet in late pregnancy, neither the average fasting blood glucose (control group: 4.90 mmol l-1, intervention group: 4.96 mmol l-1) (β= 0.05, [95% CI -0.22 to 0.31], P=0.720) nor hyper-fasting blood glucose incidence (control group: 0.19, intervention group: 0.26) (β= 0.07, [95% CI -0.07 to 0.20], P=0.335) were significant different between the two groups. And we found low-density lipoprotein level were higher in the intervention group (3.21 mmol l-1) compared to the control group (2.52 mmol l-1) (β= 0.70, [95% CI 0.07 to 1.34], P=0.031). Additionally, post-hoc analysis showed that the incidence of elevated 1-hour postprandial glucose was significantly higher in the intervention group (0.42) than in the control group (0.28) (β= 0.14, [95% CI 0.01 to 0.27], P=0.036). No difference was found regarding any perinatal outcomes between the two groups.

Conclusions: Bedtime snack did not reduce the risk of morning hyperglycaemia and adverse perinatal outcomes in women with gestational diabetes mellitus, but exacerbated lipid markers and the 1-hour postprandial glucose profile. Our study did not support clinicians and relevant guidelines to recommend bedtime snacking as a form of glycaemic control in women with GDM.

Keywords: Gestational diabetes mellitus; Fasting glucose; Snacks; Randomized controlled trail

摘要

背景：尽管指南建议妊娠期糖尿病（gestational diabetes mellitus，GDM）女性进行睡前加餐以管理血糖水平，但证据尚不充分。

目的：本研究的目的是为了探究睡前零食对GDM女性孕期的血糖控制效果，并探究其对于孕晚期的血脂水平和围产期结局的影响，为GDM的科学控制及指南制定提供高质量的循证学证据。

方法：本研究于2023年12月至2024年7月在中国安徽省马鞍山市妇幼保健院开展，是一项采用开放标签、平行分组设计的随机对照试验。采用随机化的方式将研究对象分为对照组和干预组。对干预组进行每天睡前吃25克坚果的加餐以及常规的GDM生活方式指导，对照组则进行常规GDM生活方式指导及睡前不吃任何食物。干预总共持续8周，在此期间，使用家用血糖仪每周测量3次空腹血糖，2次餐后1小时和餐后2小时血糖。妊娠晚期（约34周）时，在实验室测量糖化血红蛋白、高密度脂蛋白、低密度脂蛋白、甘油三酯和总胆固醇水平，并收集分娩结局信息（出生体重、分娩孕周、分娩方式）。主要结局指标为8周期间的空腹血糖水平和高血糖发病率。次要结局为妊娠晚期的糖化血红蛋白、高密度脂蛋白、低密度脂蛋白、甘油三酯和总胆固醇水平。采用广义估计方程和协变量分析对主要结局进行分析，采用多元线性回归对次要结局进行分析。同时，采用广义估计方程、协变量分析、多元线性回归和逻辑回归对1小时餐后血糖、2小时餐后血糖和围产结局指标进行事后分析。

结果：共62名GDM女性纳入并完成随访，其中干预组31人，对照组31人。在调整孕妇年龄、孕前体重指数、孕中期血糖、孕中期血脂和孕晚期饮食后，两组的平均空腹血糖（对照组：4.90 mmol/L，干预组：4.96 mmol/L）（β=0.05，[95% CI -0.22~0.31]，P=0.720）和高血糖发病率（对照组：0.19，干预组：0.26）（β=0.07，[95% CI -0.07~0.20]，P=0.335）均无显著差异。但是干预组的低密度脂蛋白水平高于对照组（3.21 mmol/L vs 2.52 mmol/L）（β=0.70，[95% CI 0.07~1.34]，P=0.031）。此外，事后分析显示，干预组餐后1小时高血糖发生率显著高于对照组（0.42 vs 0.28）（β=0.14，[95% CI 0.01~0.27]，P=0.036）。两组在围产结局方面无显著差异。

结论：睡前零食并未降低GDM女性的高血糖和不良围产结局的风险，反而升高了血脂和餐后1小时血糖水平。本研究尚不支持临床医生和相关指南将睡前零食作为GDM女性血糖控制的一种方式。

关键词：妊娠期糖尿病；空腹血糖；零食；随机对照试验