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

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 (<50 g), 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.

Conflict of interest statement

J.P.L. holds founder shares and advises for Metabolic Insights Inc., and is volunteer Chief Scientific Officer for the not-for-profit Institute for Personalized Therapeutic Nutrition. S.M. is employed as Chief Executive Officer for the not-for-profit Institute for Personalized Therapeutic Nutrition. J.W. is a member of the Scientific Advisory Board, and has received travel support and speaker’s honoraria, from Atkins Nutritionals Inc. J.D.J. is Chair of the Board for the Institute for Personalized Therapeutic Nutrition and receives no compensation. C.D., J.S., A.M.B., and K.G. have nothing to declare.

© 2021. The Author(s).

Figures

Fig. 1. Trial CONSORT flow diagram.

Pharm-TCR Pharmacist-led therapeutic carbohydrate restriction, TAU Treatment-as-usual, ITT Intention-to-treat. Created with BioRender.com.

Fig. 2. Descriptive analysis of weekly data collected in the Pharm-TCR group.

Data are weekly effect estimates for changes from baseline (Week 0; gray line) with confidence intervals in the Pharm-TCR group for (a) medication effect score (MES); (b) body mass index; (c) waist circumference; (d) body fat percentage; (e) systolic blood pressure; and (f) diastolic blood pressure. Values are effect estimates for adjusted mean change from baseline in a–f. Bias-adjusted and accelerated confidence intervals derived from non-parametric bootstrap analysis are presented in panel a. Error bars for panels b–f represent 95% confidence intervals. Data are based on participants for which baseline data were collected (n = 92) except for waist circumference (n = 90) and body fat percentage (n = 91). Source data are provided as a source data file.