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.

Effect of Ketogenic Diet on Quality of Life in Adults with Chronic Disease: A Systematic Review of Randomized Controlled Trials

“…Regarding chronic diseases, four studies were conducted on cancer patients (several types of stages 2 and 3 cancer [36], ovarian or endometrial cancer [42], glioblastoma [39], and breast cancer [40]), two on patients with neurological disorders (multiple sclerosis [43] and Alzheimer's disease [41]), two on patients with obesity, and type II diabetes [37,38], and one on patients with knee osteoarthritis [44]. Regarding the design, only the study by Philips et al [41], was a two-period crossover RCT.…”

“…The prescription of the KD varied between studies including a CHO intake less than 20 g per day [42,44], or less than 50 g per day [37,38] or net CHO less than 6% of total…”

“…Characteristics of the included RCTs are summarized in Table 1 and detailed in Supplementary Material Table S2. Three studies were conducted in the USA [36][37][38], and one study took place in each of Trinidad and Tobago [36], Australia [37], Canada [38], UK [39], Iran [40], and in New Zealand [41]. Most of the studies were published within the last two years [37][38][39][41][42][43][44].…”

“…Three studies were conducted in the USA [36][37][38], and one study took place in each of Trinidad and Tobago [36], Australia [37], Canada [38], UK [39], Iran [40], and in New Zealand [41]. Most of the studies were published within the last two years [37][38][39][41][42][43][44].…”

“…The prescription of the KD varied between studies including a CHO intake less than 20 g per day [42,44], or less than 50 g per day [37,38] or net CHO less than 6% of total energy per day [41]. Only in Durrer et al [38] did the intervention consist of a commercial ketogenic weight loss diet plan supplemented with whole foods; whereas in Augustus et al [36], Lee et al [43], and Martin McGill et al [39], the intervention con-sisted of MCT-KD. The duration of intervention ranged between 12 weeks [38,[40][41][42]44] and 12 months [37].…”