一种多菌种益生菌补充剂对1型糖尿病成人血糖控制和代谢状况的有益影响：一项随机、双盲、安慰剂对照的试点研究。
The Beneficial Effects of a Multispecies Probiotic Supplement on Glycaemic Control and Metabolic Profile in Adults with Type 1 Diabetes: A Randomised, Double-Blinded, Placebo-Controlled Pilot-Study.
作者信息
Zhang Xiuzhen, Zhang Ying, Luo Limei, Le Ying, Li Ying, Yuan Fengyi, Wu Yan, Xu Ping
机构信息
Department of Endocrinology and Metabolism, Shenzhen People's Hospital (The Second Clinical Medical College, Jinan University; The First Affiliated Hospital, Southern University of Science and Technology), Shenzhen, Guangdong, People's Republic of China.
出版信息
Diabetes Metab Syndr Obes. 2023 Mar 18;16:829-840. doi: 10.2147/DMSO.S400119. eCollection 2023.
OBJECTIVE
In this pilot-study, the effects of a multispecies probiotic supplement on glycaemic control and metabolic parameters in adults with type 1 diabetes (T1DM) were explored.
MATERIAL AND METHODS
A total of 50 T1DM patients were enrolled and randomly placed into a group receiving capsules containing multi-probiotic strains (, , ) and insulin (probiotics group, n = 27) or a group receiving a placebo and insulin (placebo group, n = 23). All patients underwent continuous glucose monitoring at baseline and 12 weeks after intervention. The primary outcomes were determined by comparing factors such as changes in fasting blood glucose (FBG) and haemoglobin A1c (HbA1c) between the groups.
RESULTS
Probiotic supplementation significantly reduced FBG (-1.0 ± 4.7 vs 1.8 ± 4.7 mmol/L, p = 0.048), 30 min postprandial glucose (-0.5 ± 4.6 vs 1.9 ± 3.3 mmol/L, p = 0.0495), and low-density lipoprotein cholesterol (-0.07 ± 0.45 vs 0.32 ± 0.78 mmol/L, p = 0.0413), compared with the placebo. Although not statistically significant, probiotic supplementation also lowered HbA1c levels by 0.49% (-5.33 mmol/mol, p = 0.310). Besides, no significant difference was observed in the continuous glucose monitoring (CGM) parameters between the two groups. Further subgroup analysis revealed a significant reduction in mean sensor glucose (MSG; -0.75 (-2.11, 0.48) mmol/L vs 1.51 (-0.37, 2.74) mmol/L, p = 0.010) and time above range (TAR; -5.47 (-20.1, 3.04)% vs 18.9 (-1.11, 35.6)%, p = 0.006), as well as an greater improvement in the time in range (TIR; 9.32 (-4.84, 16.6)% vs -19.9 (-31.4, 0.69)%, p = 0.005) in male patients than female patients in the probiotics group.
CONCLUSION
Multispecies probiotics exerted beneficial effects on fasting and postprandial glucose and lipid profiles in adult T1DM patients, especially for male patients and those with higher baseline FBG levels.
目的
在这项初步研究中，探讨了一种多菌种益生菌补充剂对1型糖尿病（T1DM）成人患者血糖控制和代谢参数的影响。
材料与方法
共招募了50名T1DM患者，并随机分为两组，一组接受含有多种益生菌菌株（、、）的胶囊和胰岛素治疗（益生菌组，n = 27），另一组接受安慰剂和胰岛素治疗（安慰剂组，n = 23）。所有患者在基线时和干预后12周进行持续葡萄糖监测。通过比较两组之间空腹血糖（FBG）和糖化血红蛋白（HbA1c）等因素的变化来确定主要结局。
结果
与安慰剂相比，补充益生菌显著降低了FBG（-1.0±4.7 vs 1.8±4.7 mmol/L，p = 0.048）、餐后30分钟血糖（-0.5±4.6 vs 1.9±3.3 mmol/L，p = 0.0495）和低密度脂蛋白胆固醇（-0.07±0.45 vs 0.32±0.78 mmol/L，p = 0.0413）。虽然未达到统计学显著性，但补充益生菌也使HbA1c水平降低了0.49%（-5.33 mmol/mol，p = 0.310）。此外，两组在持续葡萄糖监测（CGM）参数方面未观察到显著差异。进一步的亚组分析显示，益生菌组男性患者的平均传感器葡萄糖（MSG；-0.75（-2.11，0.48）mmol/L vs 1.51（-0.37，2.74）mmol/L，p = 0.010）和高于范围时间（TAR；-5.47（-20.1，3.04）% vs 18.9（-1.11，35.6）%，p = 0.006）显著降低，且血糖在目标范围内时间（TIR；9.32（-4.84，16.6）% vs -19.9（-31.4，0.69）%，p = 0.005）的改善程度大于女性患者。
结论
多菌种益生菌对成年T1DM患者的空腹和餐后血糖及血脂状况具有有益作用，尤其是对男性患者和基线FBG水平较高者。
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