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孕期膳食补充剂对妊娠期糖尿病患者血糖和脂代谢的影响:一项随机对照试验的系统评价和网络荟萃分析方案。

The effects of prenatal dietary supplements on blood glucose and lipid metabolism in gestational diabetes mellitus patients: A systematic review and network meta-analysis protocol of randomized controlled trials.

机构信息

Department of Community Medicine, R. G. Kar Medical College, Kolkata, West Bengal, India.

Department of Mathematics, Mankar College, Mankar, West Bengal, India.

出版信息

PLoS One. 2022 May 3;17(5):e0267854. doi: 10.1371/journal.pone.0267854. eCollection 2022.

Abstract

BACKGROUND

Several randomized controlled trials (RCT) investigated antenatal dietary supplements' effect on gestational diabetes mellitus patients' fasting plasma glucose levels, glycated hemoglobin levels, homeostasis model assessment of- insulin resistance and β-cell function, quantitative insulin sensitivity check index for glucose, high-, low-, and very-low-density lipoprotein cholesterol levels, total cholesterol levels, triglyceride levels, and triglyceride to high-density lipoprotein ratio. However, an efficacy comparison across various dietary supplements and their co-supplements are unavailable for these outcomes. Therefore, a systematic review protocol is proposed here to make a network meta-analysis (NMA)-based juxtaposition across the following dietary supplements- vitamins, Myo-inositol, choline, minerals, probiotics, prebiotics, synbiotics, and omega-3 fatty acids.

MATERIALS AND METHODS

A database search will ensue in the PubMed, Embase, and Scopus databases for RCTs testing the above, irrespective of their geographical origin. Data on population characteristics, compared interventions, and outcomes of interest will get abstracted from the studies included in the proposed review. Each of the reviewed studies will get appraised using the revised Cochrane tool. For each outcome, the comparative efficacy across interventions will be estimated in weighted or standardized mean difference using the frequentist method NMA and presented with their 95% confidence interval using league tables. By constructing network maps and comparison-adjusted funnel plots, a visual assessment of the inter-interventional relation and publication bias in each NMA model will happen, respectively. The best-ranked intervention prediction for respective outcomes will transpire using the surface under the cumulative ranking curve values. The Stata statistical software (version 16) will be used for analysis, and statistical significance will be determined at p<0.05 and 95% confidence interval.

TRIAL REGISTRATION

PROSPERO registration number: CRD42020214378.

摘要

背景

几项随机对照试验(RCT)研究了产前膳食补充剂对妊娠期糖尿病患者空腹血浆葡萄糖水平、糖化血红蛋白水平、胰岛素抵抗和β细胞功能的稳态模型评估、葡萄糖定量胰岛素敏感性检查指数、高低密度脂蛋白胆固醇水平、总胆固醇水平、甘油三酯水平以及甘油三酯与高密度脂蛋白比值的影响。然而,对于这些结果,各种膳食补充剂及其联合补充剂的疗效比较尚不可用。因此,本研究提出了一个系统评价方案,旨在对以下膳食补充剂进行基于网络荟萃分析(NMA)的对比,包括维生素、肌醇、胆碱、矿物质、益生菌、益生元、合生元和欧米伽-3 脂肪酸。

材料和方法

将在 PubMed、Embase 和 Scopus 数据库中进行数据库搜索,以检索测试上述内容的 RCT,无论其地理位置如何。将从纳入本综述的研究中提取研究人群特征、比较干预措施和感兴趣的结局数据。将使用修订后的 Cochrane 工具对每个综述研究进行评估。对于每个结局,将使用频繁主义方法 NMA 以加权或标准化均数差估计干预措施之间的相对疗效,并使用列线图呈现其 95%置信区间。通过构建网络图和比较调整的漏斗图,分别对每个 NMA 模型中的干预措施之间的关系和发表偏倚进行视觉评估。使用累积排序曲线值下的表面将出现对每个结局的最佳排名干预预测。使用 Stata 统计软件(版本 16)进行分析,统计显著性将在 p<0.05 和 95%置信区间确定。

试验注册

PROSPERO 注册号:CRD42020214378。

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