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.
Keywords: A1C; Diabetes; Diet; Glucose; Insulin; Ketogenic diet; Nutrition; Pharmacy.
Conflict of interest statement
JPL and JDJ are Co-Chief Scientific Officers and SM is CEO for the Institute for Personalized Therapeutic Nutrition (IPTN), a not-for-profit organization with goals of helping prepare healthcare providers to safely implement therapeutic nutrition.
JPL is Scientific Advisor and holds shares in Metabolic Insights Inc., a for-profit company designing non-invasive metabolic monitoring tools.
Although Ideal Protein is not a partner for this research, Pharmasave pharmacies can sell Ideal Protein weight loss products.
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