Pharmacist-led Therapeutic Nutritional Intervention in Type 2 Diabetes

Impact of a Pharmacist-led Therapeutic Nutritional Intervention on Medications and Glucose Control in Type 2 Diabetes

Type 2 diabetes represents a significant burden to both the individual and our healthcare system. Individuals with type 2 diabetes are typically prescribed one or more glucose-lowering medications, many of which have undesirable side effects (e.g., nausea, risk of cardiovascular complications, weight gain) and cost our healthcare system a lot of money. An alternative strategy to lower blood glucose is to consume a low-carbohydrate diet. However, adjusting medications after choosing to follow a low-carbohydrate diet can be difficult. Delivering a low-carbohydrate diet through pharmacists could circumvent this difficulty in medications adjustment because pharmacists are trained to adjust medications. In this study the investigators will determine whether type 2 diabetes patients can reduce medications and improve blood glucose by following a low-carbohydrate, low-calorie diet under the direction of a pharmacist.

Study Overview

• Status: Completed
• Conditions: Diet Modification
• Intervention / Treatment: Behavioral: Low-carbohydrate Therapeutic Nutrition

• Study Type: Interventional
• Enrollment (Actual): 188
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Kelowna, British Columbia, Canada, V1V1V7
      • University of British Columbia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Between the ages of 30 and 75, have type 2 diabetes mellitus diagnosed by a physician, are taking one or more glucose-lowering medications, have a BMI ≥30, have no contraindications to following low-carbohydrate, energy-restricted, high-protein diet, and can read and speak English.

Exclusion Criteria:

Exlcusion criteria are:

1. Recent (within the last 2 years) diagnosis of coronary heart disease, stroke, or a heart attack.
2. Unstable cardiovascular disorder.
3. History of liver disease.
4. History of kidney disease or impaired renal function.
5. Previously undergone bariatric surgery.
6. Multiple sclerosis or other diagnosed neurological disease.
7. Currently pregnant or lactating, or planning on becoming pregnant in the next 12 months.
8. Any form of cancer within the last 5 years.
9. Body mass index (BMI) of <30.
10. Dietary restrictions that do not allow you to follow a low-carbohydrate, energy-restricted, high-protein diet (e.g., vegan, food allergies).
11. Any sensitivities to the ingredients in the pre-packaged foods

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low-carbohydrate Therapeutic Nutrition; A 12-week low-carbohydrate, energy-restricted diet will be administered using a combination of pre-packaged foods and whole foods from pre-specified lists.	Behavioral: Low-carbohydrate Therapeutic Nutrition; The pharmacist or pharmacy lifestyle coach will work with the participant to develop a diet plan that is low in carbohydrate and energy-restricted based on personal preferences and characteristics. A combination of pre-packaged low-carbohydrate foods and whole foods from pre-specified lists will be used.
No Intervention: Treatment-as-usual waitlist control; Participants will receive standard lifestyle advice to follow a low-fat, low-sugar, high fibre diet and aim to accumulate 150 minutes of moderate activity per week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants not on glucose-lowering medications	Number of individuals taking no medications divided by the total number of participants.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin A1C	Blood test to measure glucose control	12 weeks
Reduction in glucose-lowering medications	Reduction in total dose of glucose-lowering medications	12 weeks
Body mass index	Body mass in kilograms divided by height in meters squared.	12 weeks
Waist circumference	Waist circumference in centimeters	12 weeks
Body fat percentage	Body fat percentage measured by bioelectrical impedance analysis	12 weeks
Body mass	Body mass in kg	12 weeks
Health related quality of life	Short-form (SF)-20 questionnaire	12 weeks
Reduction in non-glucose lowering medications	Dose of medications other than glucose-lowering	12 weeks
Blood lipid profile	triglycerides, HDL and LDL cholesterol	12 weeks
Fasting insulin	Fasting insulin	12 weeks
Fasting C-peptide	fasting C-peptide	12 weeks
C-reactive protein	Fasting high-sensitivity C-reactive protein	12 weeks
Liver enzymes	liver alanine amino transferase, aspartate aminotransferase, gamma-gluatmyl transpeptidase	12 weeks
Fasting plasma glucose	Fasting plasma glucose	12 weeks
Systolic Blood Pressure	Systolic Blood Pressure measured by automatic cuff	12 weeks
Diastolic Blood Pressure	Diastolic Blood Pressure measured by automatic cuff	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Habitual physical activity	Godin leisure-time exercise questionnaire	12 weeks
Energy intake	3-day diet record	Baseline, 6 weeks, and 12 weeks
Macronutrient intake	3-day diet record	Baseline, 6 weeks, and 12 weeks
Intervention Satisfaction	Satisfaction with intervention delivery questionnaire	12 weeks

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: Mitacs; Pharmasave

Publications and helpful links

General Publications

• Durrer C, McKelvey S, Singer J, Batterham AM, Johnson JD, Gudmundson K, Wortman J, Little JP. A randomized controlled trial of pharmacist-led therapeutic carbohydrate and energy restriction in type 2 diabetes. Nat Commun. 2021 Sep 10;12(1):5367. doi: 10.1038/s41467-021-25667-4. Erratum In: Nat Commun. 2022 May 5;13(1):2590.
• Durrer C, McKelvey S, Singer J, Batterham AM, Johnson JD, Wortman J, Little JP. Pharmacist-led therapeutic carbohydrate restriction as a treatment strategy for type 2 diabetes: the Pharm-TCR randomized controlled trial protocol. Trials. 2019 Dec 27;20(1):781. doi: 10.1186/s13063-019-3873-7.

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2017
• Primary Completion (Actual): November 15, 2019
• Study Completion (Actual): July 15, 2020

Study Registration Dates

• First Submitted: June 6, 2017
• First Submitted That Met QC Criteria: June 6, 2017
• First Posted (Actual): June 8, 2017

Study Record Updates

• Last Update Posted (Actual): September 11, 2020
• Last Update Submitted That Met QC Criteria: September 9, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Low-carbohydrate; Low calorie; Energy restricted
• Other Study ID Numbers: H16-01539

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual values will be reported in figures if applicable.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No