Background
T2DM, diabetes
TYPE 2 DIABETES, DIABETES
Metformin is the most widely prescribed anti-diabetic agent in the world and a first line treatment for type 2 diabetes (T2DM) in both adults and children (While the precise mechanism of metformin-induced GI side effects remains elusive, emerging data strongly suggest that certain dietary fibers or fiber supplements, including prebiotics which affect the microbiome, may benefit patients with diabetes (This pilot study examined the use of a prebiotic with polyphenols as an adjunct to improving metformin tolerability and facilitating short-term dose escalation and explored the underlying gut-based mechanisms of metformin and fiber in Y-T2DM. Our primary objective was to compare GI symptoms at initiation of daily metformin therapy when used with a daily metformin/prebiotic agent versus a metformin/placebo agent. We hypothesized that the metformin/prebiotic agent would be associated with higher tolerability scores (a composite score of lower GI-related side effects and stool consistency) compared to the placebo. Additional exploratory aims included evaluating changes in glucose and insulin concentrations and changes in gut microbiota diversity and bacterial phylogenetic abundances after the daily metformin/prebiotic agent use in contrast to the placebo.