A randomized controlled trial of pharmacist-led therapeutic carbohydrate and energy restriction in type 2 diabetes

Cody Durrer, Sean McKelvey, Joel Singer, Alan Mark Batterham, James Johnson, Kelsey Gudmundson, Jay Wortman, Jonathan P. Little

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Abstract

Type 2 diabetes can be treated, and sometimes reversed, with dietary interventions; however,
strategies to implement these interventions while addressing medication changes are lacking. We
conducted a 12-week pragmatic, community-based parallel-group randomized controlled trial
(ClinicalTrials.gov: NCT03181165) evaluating the effect of a low-carbohydrate (<50g), energy-
restricted diet (~850-1100 kcal/day; Pharm-TCR; n=98) compared to treatment-as-usual (TAU;
n=90), delivered by community pharmacists, on glucose-lowering medication use,
cardiometabolic health, and health-related quality of life. The Pharm-TCR intervention was
effective in reducing the need for glucose-lowering medications through complete
discontinuation of medications (35.7%; n=35 vs. 0%; n=0 in TAU; p<0.0001) and reduced
medication effect score compared to TAU. These reductions occurred concurrently with
clinically meaningful improvements in hemoglobin A1C, anthropometrics, blood pressure, and
triglycerides (all p<0.0001). These data indicate community pharmacists are a viable and
innovative option for implementing short-term nutritional interventions for people with type 2
diabetes, particularly when medication management is a safety concern.
Original languageEnglish
JournalNature Communications
Publication statusAccepted/In press - 12 Aug 2021

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