After analyzing data from the first ten participants, a preplanned interim analysis using O’Brien-Fleming criteria (p-value threshold of 0.0051) showed a strong trend toward negative results for our key outcomes (GIR and FMD).
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A one-week reduced-carbohydrate diet to mitigate iatrogenic peripheral hyperinsulinemia does not improve insulin sensitivity or endothelial function in a randomized, crossover trial in patients with type 1 diabetes.
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