Tier 2 — strong

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

Zhang Y, Gu Y, Ren H, Wang S, Zhong H, Zhao X, Ma J, Gu X, Xue Y, Huang S, Yang J, Chen L, Chen G, Qu S, Liang J, Qin L, Huang Q, Peng Y, Li Q, Wang X, Kong P, Hou G, Gao M, Shi Z, Li X, Qiu Y, Zou Y, Yang H, Wang J, Xu G, Lai S, Li J, Ning G, Wang W
Nature communications 2020 11(1):5015

Bibliography

PubMed
PMID 33024120
PubMed Central
PMC7538905
Trial registry
View on ClinicalTrials.gov Registered trial — results not yet published in a peer-reviewed journal.
Funding
Funding was not established from the accessible source; this is not a declaration of no funding.
Competing interests
The authors declared no competing interests in the publication.

Study snapshot

DesignMulticenter double-blind four-arm randomized trial
ModelHuman participants; see population
Sample409 participants completed randomized treatment
InterventionBerberine, probiotics, combination or placebo after gentamicin run-in
Duration12 weeks
EndpointsFasting and postload glucose; HbA1c and insulin sensitivity; Lipid profile and tolerability

What the study showed, in plain terms

PREMOTE found a greater HbA1c decline in the berberine-containing arms than in placebo or probiotics alone. Microbiome analyses generated a possible bile-acid mechanism.

Key findings

  • HbA1c changed about -0.99 percentage points with berberine versus -0.59 with placebo.
  • Gastrointestinal complaints were more frequent with berberine.

What this study can and cannot tell us

Antibiotic pretreatment and newly diagnosed diabetes limit generalization; microbial associations do not fully establish mediation.

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