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

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#berberine #diabetes-mellitus-type-2 #female #gastrointestinal-microbiome #glycated-hemoglobin

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

Zhang et al., 2020 | Nat Commun | Rct

Citation

Zhang Yifei, Gu Yanyun, ... Wang Weiqing. Gut microbiome-related effects of berberine and probiotics on type 2 diabetes (the PREMOTE study). Nat Commun. 2020-Oct-06;11(1):5015. doi:10.1038/s41467-020-18414-8

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).

Key Findings

(Clinicaltrial.gov Identifier: NCT02861261).

Outcomes Measured

  • Requires manual extraction

Population

Field Value
Population See abstract
Sample Size See abstract
Age Range See abstract
Condition diabetes

MeSH Terms

  • Berberine
  • Diabetes Mellitus, Type 2
  • Female
  • Gastrointestinal Microbiome
  • Glycated Hemoglobin
  • Humans
  • Hypoglycemic Agents
  • Male
  • Metagenome
  • Middle Aged
  • Placebos
  • Probiotics
  • Treatment Outcome

Evidence Classification

  • Level: Rct
  • Publication Types: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
  • Vertical: berberine

Provenance

Source extracted via PubMed E-utilities API on 2026-04-09