Pathology, research and practice · 2026
BCG vaccination as an adjunctive strategy in type 1 diabetes: A systematic review of immunometabolic effects and clinical evidence.
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Shamsnia Hedieh Sadat, Peyrovinasab Amirreza, Niknejad Amirhossein, Soltani Sanam, Nikdoost Paria, Jamshidi Porsa, Mirhassani Reihaneh, Abdolghaffari Amir Hossein
Аннотация
AIMS: This study critically evaluates the role of Bacille Calmette-Guérin (BCG) vaccination in the prevention and adjunctive treatment of type 1 diabetes mellitus (T1D), with emphasis on its immunomodulatory and metabolic mechanisms.
METHODS: A systematic literature search was performed using PubMed, Google Scholar, and Cochrane databases. Clinical trials, cohort, case-control, and epidemiological studies published in English between 1969 and May 2026 were included.
RESULTS: The evidence was divided into studies supporting the hypothesis that BCG has beneficial effects in diabetes and those opposing it. Supportive studies, mainly interventional and mechanistic, reported improvements in C-peptide levels, reductions in HbA1c, partial β-cell recovery, and immune modulation via TNF induction, Treg activation, and increased glycolysis. In contrast, opposing evidence, largely from large observational cohorts and some randomized trials, showed no significant association between BCG vaccination and reduced incidence or progression of diabetes. Overall, the findings were highly heterogeneous, with inconsistencies across study designs, populations, and follow-up durations.
CONCLUSIONS: The pooled evidence remains conflicting. While interventional studies support a potential adjunctive therapeutic and immunometabolic role of BCG, observational data do not confirm a protective effect against diabetes. Therefore, the hypothesis remains unproven, and robust large-scale randomized controlled trials are required to resolve these discrepancies.
METHODS: A systematic literature search was performed using PubMed, Google Scholar, and Cochrane databases. Clinical trials, cohort, case-control, and epidemiological studies published in English between 1969 and May 2026 were included.
RESULTS: The evidence was divided into studies supporting the hypothesis that BCG has beneficial effects in diabetes and those opposing it. Supportive studies, mainly interventional and mechanistic, reported improvements in C-peptide levels, reductions in HbA1c, partial β-cell recovery, and immune modulation via TNF induction, Treg activation, and increased glycolysis. In contrast, opposing evidence, largely from large observational cohorts and some randomized trials, showed no significant association between BCG vaccination and reduced incidence or progression of diabetes. Overall, the findings were highly heterogeneous, with inconsistencies across study designs, populations, and follow-up durations.
CONCLUSIONS: The pooled evidence remains conflicting. While interventional studies support a potential adjunctive therapeutic and immunometabolic role of BCG, observational data do not confirm a protective effect against diabetes. Therefore, the hypothesis remains unproven, and robust large-scale randomized controlled trials are required to resolve these discrepancies.