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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.

SUBMITTER: Durrer C

PROVIDER: S-EPMC8433183 | biostudies-literature | 2021 Sep

REPOSITORIES: biostudies-literature

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

Durrer Cody C McKelvey Sean S Singer Joel J Batterham Alan M AM Johnson James D JD Gudmundson Kelsey K Wortman Jay J Little Jonathan P JP

Nature communications 20210910 1

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 ph ...[more]

PMID: 34508090

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Project description:BACKGROUND:The current treatment paradigm for type 2 diabetes mellitus (T2D) typically involves use of multiple medications to lower glucose levels in hope of reducing long-term complications. However, such treatment does not necessarily address the underlying pathophysiology of the disease and very few patients achieve partial, complete, or prolonged remission of T2D after diagnosis. The therapeutic potential of nutrition has been highlighted recently based on results of clinical trials reporting remission of T2D with targeted dietary approaches. During the initial phase of such interventions that restrict carbohydrates and/or induce rapid weight loss, hypoglycemia presents a notable risk to patients. We therefore hypothesized that delivering very low-carbohydrate, low-calorie therapeutic nutrition through community pharmacies would be an innovative strategy to facilitate lowering of glycated hemoglobin (A1C) while safely reducing the use of glucose-lowering medications in T2D. METHODS:A community-based randomized controlled trial that is pragmatic in nature, following a parallel-group design will be conducted (N = 200). Participants will have an equal chance of being randomized to either a pharmacist-led, therapeutic carbohydrate restricted (Pharm-TCR) diet or guideline-based treatment as usual (TAU). Pharm-TCR involves a 12-week very low carbohydrate, calorie-restricted commercial diet plan led by pharmacists and lifestyle coaches with pharmacists responsible for managing medications in collaboration with the participants' family physicians. Main inclusion criteria are diagnosis of T2D, currently treated with glucose-lowering medications, age 30-75 years, and body mass index ≥ 30. The primary outcome is a binary measure of use of glucose-lowering medication. Secondary outcomes include A1C, anthropometrics and clinical blood markers. DISCUSSION:There are inherent risks involved if patients with T2D who take glucose-lowering medications follow very low carbohydrate diets. This randomized controlled trial aims to determine whether engaging community pharmacists is a safe and effective way to deliver therapeutic carbohydrate restriction and reduce/eliminate the need for glucose-lowering medications in people with T2D. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03181165. Registered on 8 June 2017.

Project description:ObjectivesThe effectiveness and costs associated with addition of pharmacist-led group medical visits to standard care for patients with Type-2 Diabetes Mellitus (T2DM) is unknown.MethodsRandomized-controlled-trial in three US Veteran Health Administration (VHA) Hospitals, where 250 patients with T2DM, HbA1c >7% and either hypertension, active smoking or hyperlipidemia were randomized to either (1) addition of pharmacist-led group-medical-visits or (2) standard care alone for 13 months. Group (4-6 patients) visits consisted of 2-hour, education and comprehensive medication management sessions once weekly for 4 weeks, followed by quarterly visits. Change from baseline in cardiovascular risk estimated by the UKPDS-risk-score, health-related quality-of-life (SF36v) and institutional healthcare costs were compared between study arms.ResultsAfter 13 months, both groups had similar and significant improvements from baseline in UKPDS-risk-score (-0.02 ±0.09 and -0.04 ±0.09, group visit and standard care respectively, adjusted p<0.05 for both); however, there was no significant difference between the study arms (adjusted p = 0.45). There were no significant differences on improvement from baseline in A1c, systolic-blood-pressure, and LDL as well as health-related quality-of-life measures between the study arms. Compared to 13 months prior, the increase in per-person outpatient expenditure from baseline was significantly lower in the group visit versus the standard care arm, both during the study intervention period and at 13-months after study interventions. The overall VHA healthcare costs/person were comparable between the study arms during the study period (p = 0.15); then decreased by 6% for the group visit but increased by 13% for the standard care arm 13 months post-study (p<0.01).ConclusionsAddition of pharmacist-led group medical visits in T2DM achieved similar improvements from baseline in cardiovascular risk factors than usual care, but with reduction in the healthcare costs in the group visit arm 13 months after completion compared to the steady rise in cost for the usual care arm.Trial registrationNCT00554671 ClinicalTrials.gov.

Project description:PurposeThe study aimed to determine the impact of pharmacist-led interventions on diabetes management at a community pharmacy in Pakistan.MethodsA one-month follow-up, randomized controlled trial (RCT) was carried out between December 1, 2016 and June 30, 2017. Sampling population consisted of patients diagnosed with type 2 diabetes mellitus (T2DM). The study population was randomized to a control group or an intervention group to determine the impact of a community pharmacist intervention on glycemic control fasting blood glucose (FBG) and random blood glucose (RBG), medication adherence (MMAS), and health-related quality of life (HRQoL) (EQ-5D-3L). Both non-pharmacological and pharmacological interventional tools were used that consist of array of charts and verbal communication by pharmacist. Outcomes for continuous variables were analyzed using paired sample t-test for time effect and one sample t-test to evaluate the study group effect. Independent sample t-test was used to compare each independent variable with dependent variable. A P-value of <.05 was considered statistically significant.ResultsThe control and intervention groups showed significant improvement (P-value < .05) in glycemic control, medication adherence, and HRQoL. However, the difference between the control and intervention groups was not statistically significant in terms of blood glucose levels and HRQoL (time trade off, TTO). There was a clinically significant association between pharmacist intervention and predefined glycemic control among the study participants (FBG: P-value < .001 and RBG: P-value = .04). A clinically significant association was also found between pharmacist intervention and medication adherence at the end of the trial compared with baseline values (P-value < .001). Similarly, a clinically significant association was found between pharmacist intervention and predefined HRQoL [TTO: P-value = .002 and EQ-VAS: P-value = .001].ConclusionA significant proportion of T2DM patients in the intervention group achieved predefined glycemic control, medication adherence, and health related quality of life.

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

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

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