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

Nat Commun. 2021 Sep 10;12(1):5367. doi: 10.1038/s41467-021-25667-4.

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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Blood Pressure Determination
  • British Columbia
  • Caloric Restriction*
  • Diabetes Mellitus, Type 2 / blood
  • Diabetes Mellitus, Type 2 / diagnosis
  • Diabetes Mellitus, Type 2 / diet therapy*
  • Diet, Carbohydrate-Restricted*
  • Female
  • Glycated Hemoglobin / analysis
  • Humans
  • Male
  • Middle Aged
  • Pharmacies / organization & administration
  • Pharmacists / organization & administration*
  • Pragmatic Clinical Trials as Topic
  • Professional Role*
  • Quality of Life
  • Treatment Outcome
  • Triglycerides / blood

Substances

  • Glycated Hemoglobin A
  • Triglycerides
  • hemoglobin A1c protein, human

Associated data

  • ClinicalTrials.gov/NCT03181165

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