Pharmacist-led therapeutic carbohydrate restriction as a treatment strategy for type 2 diabetes: the Pharm-TCR randomized controlled trial protocol

Autor: Sean McKelvey, Cody Durrer, Joel Singer, Jay Wortman, Jonathan P. Little, Alan M. Batterham, James D. Johnson
Jazyk: angličtina
Rok vydání: 2019
Předmět:
Adult
medicine.medical_specialty
Commission on Professional and Hospital Activities
Pharmacist
Medicine (miscellaneous)
030209 endocrinology & metabolism
Pharmacy
Community Pharmacy Services
Type 2 diabetes
Hypoglycemia
Pharmacists
Body Mass Index
law.invention
Study Protocol
Diet
Carbohydrate-Restricted
03 medical and health sciences
chemistry.chemical_compound
0302 clinical medicine
Randomized controlled trial
law
Pragmatic Clinical Trials as Topic
Insulin
Humans
Medicine
Pharmacology (medical)
030212 general & internal medicine
Intensive care medicine
Caloric Restriction
Nutrition
Glycated Hemoglobin
lcsh:R5-920
business.industry
Diabetes
Guideline
Ketogenic diet
medicine.disease
A1C
3. Good health
Diet
Clinical trial
Glucose
Diabetes Mellitus
Type 2
chemistry
Research Design
Patient Safety
Glycated hemoglobin
business
lcsh:Medicine (General)
Zdroj: Trials, Vol 20, Iss 1, Pp 1-9 (2019)
Trials
ISSN: 1745-6215
Popis: 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.
Databáze: OpenAIRE
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