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A 12-week trial assessing the effects of a low calorie, low carbohydrate diet facilitated by community pharmacists suggests this approach could contribute to the remission of type 2 diabetes in adult patients.
Data from a 12-week trial assessing the effects of a low calorie, low carbohydrate diet in patients with type 2 diabetes is highlighting the impact of diet in the remission of type 2 diabetes.
Results of the trial, which compared a low calorie, low carbohydrate diet against usual treatment, provided results indicating implementing such a dietary intervention through a pharmacist-led team could reduce the need of glucose-lowering medications in patients with type 2 diabetes.
“Type 2 diabetes can be treated, and sometimes reversed, with dietary interventions,” said trial investigator Jonathan Little, PhD, associate professor at the University of British Columbia’s Okanagan School of Health and Exercise Sciences, in a statement. “However, we needed a strategy to help people implement these interventions while keeping an eye on their medication changes.”
With interest and research into the effects of nutrition at an all-time high, Little and colleagues from the University of British Columbia and Teesside University in England sought to assess whether use of a delivered through community pharmacists could reduce the need for glucose-lowering medications among adult patients with type 2 diabetes. With this in mind, the Pharmacist-led Therapeutic Nutritional Intervention in Type 2 Diabetes was designed as a pragmatic, community-based parallel-group randomized controlled trial comparing the effects of a low calorie, low carbohydrate diet to typical treatment over a period of 12 weeks in a population of patients aged 30-75 years, with a diagnosis of type 2 diabetes from a physician, and a BMI of 30 kg/m2 or greater.
Conducted across 12 different community pharmacies within southern British Columbia, Canada, the trial had a primary outcome measure of use or nonuse of glucose-lowering medications after conclusion of the 12-week study period. The trial also included changes in HbA1c, glucose-lowering medication dose, BMI, body weight, and waist circumference, among others. Patients included in the trial randomized to the dietary intervention were provided with a free-of-charge diet plan that consisted of individuals food choices selected within the diet plan. Investigators noted the daily macronutrient content equated to fewer than 50 grams of carbohydrates, 35–45 grams of fat, and 110–120 grams of protein for a total of 850–1100 kcal.
Additionally, patients randomized to the intervention arm of the study took part in weekly visits to a pharmacy for visits with a lifestyle coach and pharmacist to monitor progress, collect intervention foods, and assess medication usage.
Overall, 188 patients were rolled in the trial. Of these, 98 were assigned to the intervention arm and 90 were assigned to the standard treatment arm. Investigators pointed out 78 of the 98 patients in the intervention arm completed the intervention and 60 of the 90 in the typical treatment arm completed the trial.
Upon completion of the trial, results suggested the low calorie, low carbohydrate intervention was associated with a reduction in need for glucose-lowering medications through complete discontinuation of medications, which occurred in 35 patients in the intervention arm and 0 patients in the typical treatment arm (P <.0001). Investigators pointed out patients in the dietary intervention arm also had reduced medication effect scores compared to the typical treatment arm, with these reductions occurring concurrently with clinically meaningful improvements in HbA1c, anthropometrics, blood pressure, and triglycerides (P for all <.0001).
In a safety analysis, 4 adverse events were observed among patients in the intervention arm and none reported in those within the typical treatment arm. Of the adverse events reported, 2 were related to mild hypoglycemia in patients reluctant to reduce insulin dosages to the recommended amount, 1 was related to hypoglycemic symptoms but none of the measured blood glucose values were lower than 5.2 mmol/L, and the final adverse events was a cardiac event occurring 3 weeks into the trial deemed unrelated to the intervention by a data safety and monitoring board.
“Community pharmacists have expertise in medication management and can serve an important role in overall diabetes care,” said Little. “When Type 2 diabetes patients follow a very low-carbohydrate or low-calorie diet, there is a need to reduce or eliminate glucose-lowering medications. Community pharmacists are ideally positioned to safely and effectively deliver interventions targeted at reducing diabetes medications while promoting Type 2 diabetes remission.”
This study, “A randomized controlled trial of pharmacist-led therapeutic carbohydrate and energy restriction in type 2 diabetes,” was published in Nature Communications.