Gut microbiome-related effects of berberine and probiotics on type 2 diabetes (the PREMOTE study)

Yifei Zhang, Yanyun Gu, Huahui Ren, Shujie Wang, Huanzi Zhong, Xinjie Zhao, Jing Ma, Xuejiang Gu, Yaoming Xue, Shan Huang, Jialin Yang, Li Chen, Gang Chen, Shen Qu, Jun Liang, Li Qin, Qin Huang, Yongde Peng, Qi Li, Xiaolin WangPing Kong, Guixue Hou, Mengyu Gao, Zhun Shi, Xuelin Li, Yixuan Qiu, Yuanqiang Zou, Huanming Yang, Jian Wang, Guowang Xu, Shenghan Lai, Junhua Li, Guang Ning, Weiqing Wang

Research output: Contribution to journalArticlepeer-review

Abstract

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).

Original languageEnglish (US)
Article number5015
JournalNature communications
Volume11
Issue number1
DOIs
StatePublished - Dec 1 2020

ASJC Scopus subject areas

  • Chemistry(all)
  • Biochemistry, Genetics and Molecular Biology(all)
  • Physics and Astronomy(all)

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