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| Name | Class |
|---|---|
| Mitacs | INDUSTRY |
| Pharmasave | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-carbohydrate Therapeutic Nutrition | Experimental | 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. |
|
| Treatment-as-usual waitlist control | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-carbohydrate Therapeutic Nutrition | Behavioral | 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. |
| 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 |
| 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 |
| 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 |
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:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan P Little, PhD | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of British Columbia | Kelowna | British Columbia | V1V1V7 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38797835 | Derived | Durrer C, Islam H, Cen HH, Garzon MDM, Lyu X, McKelvey S, Singer J, Batterham AM, Long JZ, Johnson JD, Little JP. A secondary analysis of indices of hepatic and beta cell function following 12 weeks of carbohydrate and energy restriction vs. free-living control in adults with type 2 diabetes. Nutr Metab (Lond). 2024 May 27;21(1):29. doi: 10.1186/s12986-024-00807-x. | |
| 34508090 |
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Individual values will be reported in figures if applicable.
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Pragmatic effectiveness trial of diet intervention led by community pharmacists versus treatment-as-usual waitlist control.
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Participants will know group assignments
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|
| 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 |
| Macronutrient intake | 3-day diet record | Baseline, 6 weeks, and 12 weeks |
| Intervention Satisfaction | Satisfaction with intervention delivery questionnaire | 12 weeks |
| 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. |
| 31881991 | Derived | 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. |