Pharmacist-led Therapeutic Nutritional Intervention in Type 2 Diabetes
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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. |
Outcome Measures
Primary Outcome Measures
- Proportion of participants not on glucose-lowering medications [12 weeks]
Number of individuals taking no medications divided by the total number of participants.
Secondary Outcome Measures
- 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
- Body mass [12 weeks]
Body mass in kg
- Health related quality of life [12 weeks]
Short-form (SF)-20 questionnaire
- Reduction in non-glucose lowering medications [12 weeks]
Dose of medications other than glucose-lowering
- 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
- 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
Other Outcome Measures
- Habitual physical activity [12 weeks]
Godin leisure-time exercise questionnaire
- Energy intake [Baseline, 6 weeks, and 12 weeks]
3-day diet record
- Macronutrient intake [Baseline, 6 weeks, and 12 weeks]
3-day diet record
- Intervention Satisfaction [12 weeks]
Satisfaction with intervention delivery questionnaire
Eligibility Criteria
Criteria
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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Recent (within the last 2 years) diagnosis of coronary heart disease, stroke, or a heart attack.
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Unstable cardiovascular disorder.
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History of liver disease.
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History of kidney disease or impaired renal function.
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Previously undergone bariatric surgery.
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Multiple sclerosis or other diagnosed neurological disease.
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Currently pregnant or lactating, or planning on becoming pregnant in the next 12 months.
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Any form of cancer within the last 5 years.
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Body mass index (BMI) of <30.
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Dietary restrictions that do not allow you to follow a low-carbohydrate, energy-restricted, high-protein diet (e.g., vegan, food allergies).
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Any sensitivities to the ingredients in the pre-packaged foods
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of British Columbia | Kelowna | British Columbia | Canada | V1V1V7 |
Sponsors and Collaborators
- University of British Columbia
- Mitacs
- Pharmasave
Investigators
- Principal Investigator: Jonathan P Little, PhD, University of British Columbia
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- H16-01539