A randomized controlled trial of pharmacist-led therapeutic carbohydrate and energy restriction in type 2 diabetes.
Cody DurrerSean McKelveyJoel SingerAlan M BatterhamJames D JohnsonKelsey GudmundsonJay WortmanJonathan Peter LittlePublished in: Nature communications (2021)
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.
Keyphrases
- healthcare
- type diabetes
- randomized controlled trial
- physical activity
- mental health
- blood pressure
- cerebrospinal fluid
- study protocol
- blood glucose
- glycemic control
- adverse drug
- regulatory t cells
- public health
- cardiovascular disease
- electronic health record
- insulin resistance
- systematic review
- weight loss
- adipose tissue
- skeletal muscle
- primary care
- risk assessment
- immune response
- emergency department
- human health
- newly diagnosed
- deep learning
- climate change
- double blind