At a glance
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A Pilot Study: Metformin as an Inflammatory Modulating Therapy in Older Adults Without Diabetes
In Brief
A Phase 2 clinical trial evaluating MetFORMIN Hydrochloride ER and Placebo for Inflammatory Response. Completed, enrolled 32 participants across 1 site.
Detailed Summary
Metformin has a well-established safety profile and it has become clear that metformin has additional salutary effects, including anti-inflammatory, anti-aging, and anti-thrombotic properties. In this study, subjects will provide both venous blood samples and stool samples in addition to completing cognitive and physiologic testing at baseline, throughout a 90 day exposure to metformin, and 30 days following exposure to metformin in order to evaluate their immune, microbiome, cellular respiration, thrombotic, and inflammatory responses.
Study Details
Timeline
Interventions
Subjects will be exposed to 500mg, 1000mg, or 1500mg of daily ER Metformin, by mouth, for up to 90 days. Subjects will have their venous blood sampled and baseline, throughout the trial, and following completion of their metformin exposure.
Subjects will be exposed to placebo, by mouth, for up to 90 days. Subjects will have their venous blood sampled and baseline, throughout the trial, and following completion of their metformin exposure.