Diet Modification
Conditions
Keywords
Low-carbohydrate, Low calorie, Energy restricted
Brief summary
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.
Interventions
BEHAVIORALLow-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.
Sponsors
Mitacs
Pharmasave
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Participants will know group assignments
Intervention model description
Pragmatic effectiveness trial of diet intervention led by community pharmacists versus treatment-as-usual waitlist control.
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants not on glucose-lowering medications | 12 weeks | Number of individuals taking no medications divided by the total number of participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body mass | 12 weeks | Body mass in kg |
| Liver enzymes | 12 weeks | liver alanine amino transferase, aspartate aminotransferase, gamma-gluatmyl transpeptidase |
| Fasting plasma glucose | 12 weeks | Fasting plasma glucose |
| Systolic Blood Pressure | 12 weeks | Systolic Blood Pressure measured by automatic cuff |
| Diastolic Blood Pressure | 12 weeks | Diastolic Blood Pressure measured by automatic cuff |
| Reduction in non-glucose lowering medications | 12 weeks | Dose of medications other than glucose-lowering |
| Hemoglobin A1C | 12 weeks | Blood test to measure glucose control |
| Reduction in glucose-lowering medications | 12 weeks | Reduction in total dose of glucose-lowering medications |
| Body mass index | 12 weeks | Body mass in kilograms divided by height in meters squared. |
| Waist circumference | 12 weeks | Waist circumference in centimeters |
| Body fat percentage | 12 weeks | Body fat percentage measured by bioelectrical impedance analysis |
| Health related quality of life | 12 weeks | Short-form (SF)-20 questionnaire |
| Blood lipid profile | 12 weeks | triglycerides, HDL and LDL cholesterol |
| Fasting insulin | 12 weeks | Fasting insulin |
| Fasting C-peptide | 12 weeks | fasting C-peptide |
| C-reactive protein | 12 weeks | Fasting high-sensitivity C-reactive protein |
Other
| Measure | Time frame | Description |
|---|---|---|
| Macronutrient intake | Baseline, 6 weeks, and 12 weeks | 3-day diet record |
| Intervention Satisfaction | 12 weeks | Satisfaction with intervention delivery questionnaire |
| Habitual physical activity | 12 weeks | Godin leisure-time exercise questionnaire |
| Energy intake | Baseline, 6 weeks, and 12 weeks | 3-day diet record |
Countries
Canada
Outcome results
None listed