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Trials should co-primary (1) mechanistic change (e.g., Prx cycling, 2-OH-E, LIP) and (2) clinical improvement (function, organ scores), preventing the common trap of ROS lowering without benefit (Guideline 2022)
Sitagliptin, a dipeptidyl peptidase-4 inhibitor, was selected as an active-comparator placebo proxy because it was recommended in clinical guidelines as a second-line glucose-lowering therapy, had a similar high cost to the study drugs, showed no effect on cardiovascular outcomes in a large randomized controlled trial and has been validated as a placebo proxy in prior claims-based research 20,41
As the conversation around weight loss changes, so must the strategies used to promote long-term health
(2023) JAMA, 330: 537.(261)Feng L, et al
ROS are mainly derived from the mitochondria where they are regularly produced as a natural byproduct of metabolism [55]
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