TY - JOUR
T1 - Gut microbiome-related effects of berberine and probiotics on type 2 diabetes (the PREMOTE study)
AU - Zhang, Yifei
AU - Gu, Yanyun
AU - Ren, Huahui
AU - Wang, Shujie
AU - Zhong, Huanzi
AU - Zhao, Xinjie
AU - Ma, Jing
AU - Gu, Xuejiang
AU - Xue, Yaoming
AU - Huang, Shan
AU - Yang, Jialin
AU - Chen, Li
AU - Chen, Gang
AU - Qu, Shen
AU - Liang, Jun
AU - Qin, Li
AU - Huang, Qin
AU - Peng, Yongde
AU - Li, Qi
AU - Wang, Xiaolin
AU - Kong, Ping
AU - Hou, Guixue
AU - Gao, Mengyu
AU - Shi, Zhun
AU - Li, Xuelin
AU - Qiu, Yixuan
AU - Zou, Yuanqiang
AU - Yang, Huanming
AU - Wang, Jian
AU - Xu, Guowang
AU - Lai, Shenghan
AU - Li, Junhua
AU - Ning, Guang
AU - Wang, Weiqing
N1 - Publisher Copyright:
© 2020, The Author(s).
PY - 2020/12/1
Y1 - 2020/12/1
N2 - Human gut microbiome is a promising target for managing type 2 diabetes (T2D). Measures altering gut microbiota like oral intake of probiotics or berberine (BBR), a bacteriostatic agent, merit metabolic homoeostasis. We hence conducted a randomized, double-blind, placebo-controlled trial with newly diagnosed T2D patients from 20 centres in China. Four-hundred-nine eligible participants were enroled, randomly assigned (1:1:1:1) and completed a 12-week treatment of either BBR-alone, probiotics+BBR, probiotics-alone, or placebo, after a one-week run-in of gentamycin pretreatment. The changes in glycated haemoglobin, as the primary outcome, in the probiotics+BBR (least-squares mean [95% CI], −1.04[−1.19, −0.89]%) and BBR-alone group (−0.99[−1.16, −0.83]%) were significantly greater than that in the placebo and probiotics-alone groups (−0.59[−0.75, −0.44]%, −0.53[−0.68, −0.37]%, P < 0.001). BBR treatment induced more gastrointestinal side effects. Further metagenomics and metabolomic studies found that the hypoglycaemic effect of BBR is mediated by the inhibition of DCA biotransformation by Ruminococcus bromii. Therefore, our study reports a human microbial related mechanism underlying the antidiabetic effect of BBR on T2D. (Clinicaltrial.gov Identifier: NCT02861261).
AB - Human gut microbiome is a promising target for managing type 2 diabetes (T2D). Measures altering gut microbiota like oral intake of probiotics or berberine (BBR), a bacteriostatic agent, merit metabolic homoeostasis. We hence conducted a randomized, double-blind, placebo-controlled trial with newly diagnosed T2D patients from 20 centres in China. Four-hundred-nine eligible participants were enroled, randomly assigned (1:1:1:1) and completed a 12-week treatment of either BBR-alone, probiotics+BBR, probiotics-alone, or placebo, after a one-week run-in of gentamycin pretreatment. The changes in glycated haemoglobin, as the primary outcome, in the probiotics+BBR (least-squares mean [95% CI], −1.04[−1.19, −0.89]%) and BBR-alone group (−0.99[−1.16, −0.83]%) were significantly greater than that in the placebo and probiotics-alone groups (−0.59[−0.75, −0.44]%, −0.53[−0.68, −0.37]%, P < 0.001). BBR treatment induced more gastrointestinal side effects. Further metagenomics and metabolomic studies found that the hypoglycaemic effect of BBR is mediated by the inhibition of DCA biotransformation by Ruminococcus bromii. Therefore, our study reports a human microbial related mechanism underlying the antidiabetic effect of BBR on T2D. (Clinicaltrial.gov Identifier: NCT02861261).
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U2 - 10.1038/s41467-020-18414-8
DO - 10.1038/s41467-020-18414-8
M3 - Article
C2 - 33024120
AN - SCOPUS:85092026742
SN - 2041-1723
VL - 11
JO - Nature communications
JF - Nature communications
IS - 1
M1 - 5015
ER -