The effects of prebiotics on gastrointestinal side effects of metformin in youth: A pilot randomized control trial in youth-onset type 2 diabetes.
The effects of prebiotics on gastrointestinal side effects of metformin in youth: A pilot randomized control trial in youth-onset type 2 diabetes.
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益生元对二甲双胍在青年中的胃肠道副作用的影响：一项试验2型糖尿病的试验随机对照试验。
DOI：
10.3389/fendo.2023.1125187
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发表时间：
2023
影响因子：
5.2
通讯作者：
中科院分区：
文献类型：
--
作者：
Yadav 博士是 Postbiotics Inc 的首席科学官兼联合创始人，与这项工作没有利益冲突。所有其他作者没有需要披露的利益冲突。二甲双胍是唯一被批准用于患有 2 型糖尿病 (Y-T2DM) 的青少年的一线口服降糖药，但通常会引起胃肠道 (GI) 副作用，这可能会降低治疗依从性和疗效。摄入益生元可以通过改变微生物群组成和活性来减少二甲双胍的副作用。本研究的目的是确定益生元补充剂改善二甲双胍引起的胃肠道症状的可行性和耐受性，并探索血糖的变化和微生物群多样性的变化。在一项两阶段试点临床试验中，我们在为期 1 周的随机双盲交叉设计（第 1 阶段）中比较了每 1-2 天的大便频率和大便形状，以及在开始每日二甲双胍联合每日益生元或安慰剂奶昔时的复合下消化道症状（每周），然后是 1 个月的开放标签延伸（第 2 阶段）。在每个阶段之前和之后收集血浆血糖标志物和粪便样本。 6 名 Y-T2DM 患者（17.2 ± 1.7 年（平均值 ± 标准差），67% 为男性，BMI (42 ± 9 kg/m2)、HbA1c (6.4 ± 0.6%)）完成了干预。大便频率、大便成分和胃肠道症状评分在不同组别或研究阶段没有差异。没有报告严重或严重的不良事件，代谢或血糖标志物也没有差异。第一阶段二甲双胍/安慰剂一周后，变形菌、肠杆菌科和肠杆菌目被确定为二甲双胍作用的候选生物标志物。 β 多样性的原理坐标分析表明，二甲双胍/益生元干预与一周和一个月微生物组特征的明显变化相关。 Y-T2DM 患者在短期二甲双胍治疗期间服用益生元纤维补充剂的耐受性良好，并且与微生物组成的适度变化相关。这项研究为探索益生元-二甲双胍-微生物组相互作用作为二甲双胍辅助治疗的基础的可行性提供了概念验证。 https://clinicaltrials.gov/，标识符 NCT04209075。
Dr. Yadav is Chief Scientific Officer and Co-Founder of Postbiotics Inc and has no conflict of interest with this work. All other authors have no conflicts of interest to disclose. Metformin is the only approved first-line oral glucose lowering agent for youth with type 2 diabetes mellitus (Y-T2DM) but often causes gastrointestinal (GI) side effects, which may contribute to reduced treatment adherence and efficacy. Prebiotic intake may reduce metformin’s side effects by shifting microbiota composition and activity. The aims of this study were to determine the feasibility and tolerability of a prebiotic supplement to improve metformin-induced GI symptoms and explore the changes in glycemia and shifts in the microbiota diversity. In a two-phase pilot clinical trial, we compared, stool frequency and stool form every 1-2 days, and composite lower GI symptoms (weekly) at initiation of daily metformin combined with either a daily prebiotic or a placebo shake in a 1-week randomized double-blind crossover design (Phase 1), followed by a 1-month open-labeled extension (Phase 2). Plasma glycemic markers and stool samples were collected before and after each phase. Six Y-T2DM (17.2 ± 1.7y (mean ± SD), 67% male, BMI (42 ± 9 kg/m2), HbA1c (6.4 ± 0.6%)) completed the intervention. Stool frequency, stool composition, and GI symptom scores did not differ by group or study phase. There were no serious or severe adverse events reported, and no differences in metabolic or glycemic markers. After one week Phase 1metformin/placebo Proteobacteria, Enterobacteriaceae, and Enterobacteriales were identified as candidate biomarkers of metformin effects. Principle coordinate analyses of beta diversity suggested that the metformin/prebiotic intervention was associated with distinct shifts in the microbiome signatures at one week and one month. Administration of a prebiotic fiber supplement during short-term metformin therapy was well tolerated in Y-T2DM and associated with modest shifts in microbial composition. This study provides a proof-of-concept for feasibility exploring prebiotic-metformin-microbiome interactions as a basis for adjunctive metformin therapy. https://clinicaltrials.gov/, identifier NCT04209075.
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DOI：
10.1038/ismej.2012.8
发表时间：
2012-08
期刊：
The ISME journal
影响因子：
--
作者：
通讯作者：
--
影响因子：
7.2
作者：
Hermans, M. P.;Ahn, S. A.;Rousseau, M. F.
通讯作者：
Rousseau, M. F.
影响因子：
5.8
作者：
Mishra, Sidharth P.;Jain, Shalini;Yadav, Hariom
通讯作者：
Yadav, Hariom
影响因子：
3.1
作者：
Gordon, S;Ameen, V;Carter, E
通讯作者：
Carter, E
影响因子：
11.1
作者：
Nagpal, Ravinder;Neth, Bryan J.;Yadav, Hariom
通讯作者：
Yadav, Hariom